Exercise therapy intervention for children and young adults with cerebral palsy
| ISRCTN | ISRCTN69044459 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69044459 |
| Secondary identifying numbers | 8U/2017 |
- Submission date
- 18/04/2017
- Registration date
- 21/04/2017
- Last edited
- 01/05/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Cerebral palsy (CP) is a term for a number of conditions that affect movement, posture and coordination. It occurs due to abnormal development or damage in the brain before, during or after the birth in the areas responsible for controlling muscles. CP leads to a range of symptoms, including muscle weakness, decrease in joint flexibility and coordination problems. These secondary symptoms hinder the person’s ability to perform everyday activities such as walking or negotiating steps. It has been shown that children and adults with CP are less physically active than those who have developed normally. Sedentarism leads to lower physical fitness, and elevates the risk of developing a range of health conditions. Since CP has no cure, it is of upmost importance to develop interventions to increase function, health and participation in everyday activities. The aim of this study is to evaluate the effects of an individualized exercise programme consisting of strength, flexibility and gait training for children and young adults with CP.
Who can participate?
People with spastic CP aged 9 to 24 years old, and age and sex-matched typically developing controls.
What does the study involve?
The study is divided into three parts. The first part consists of a three-month “control period”, in which participants are tested while continuing their normal living. In the second part, participants go through the three-month EXECP intervention period, in which The last part is a three-month “maintenance period” during which participants continue their normal living and choose if they want to keep following the training programe or not. The CP group take part in all three parts, and typically developing group take part only in the control period. The exercise programme involves two to three supervised exercise sessions per week for 12 weeks. These sessions involve strength and flexibility training for the legs and trunk muscles and inclined-treadmill walking. Before and after the control period (Pre-tests 1 and 2 respectively) and before and after the maintenance period (Post-tests 1 and 2), participants complete a range of assessments and questionnaires to measure their physical capacities, functionality, cardiometabolic health and factors influencing participation in physical activities. Also, families will be involved in this study by answering a questionnaire exploring motivational factors towards their children’s physical activity participation. In addition, for one week during each study part (i.e. control, intervention and maintenance), participants wear an accelerometer to record their physical activity levels.
In addition to this, a sub-study called I-SENS involving new data collection will be performed in Jyväskylä to complement the study on musculoskeletal properties, gait analysis, and behavioral proprioception. From the participants within EXECP-study, 10 children with CP and 10 TD children will be re-called and asked to participate in 3D freehand ultrasound data collection and behavioral proprioception testing.
What are the possible benefits and risks of participating?
Participants may benefit from an improvement to their physical abilities, which could help them exercise more and decrease their risk of developing health problems. Participants will receive a comprehensive neuromuscular evaluation with the possibility to personalize their treatments. There are no notable risks involved with taking part other than the general risks associated with exercising such as muscle soreness, tiredness or risk of falling.
Where is the study run from?
University of Jyväskylä (Finland)
When is the study starting and how long is it expected to run for?
September 2016 to January 2023
Who is funding the study?
1. University of Jyväskylä (Finland)
2. Olvi Foundation (Finland)
3. Ellen and Artturi Nyyssönen Foundation (Finland)
4. Academy of Finland (Finland)
5. Jane and Aatos Erkko Foundation (Finland)
6. European Commission, via its Marie Skłodowska-Curie Actions (MSCA) Postdoctoral Fellowships program
Who is the main contact?
Mr Pedro Valadao
pedro.valadao@jyu.fi
Contact information
Public
University of Jyväskylä
Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland
 ORCID ID |
0000-0003-0720-7103 |
|---|---|
| Phone | +358 40 145 9280 |
| pedro.valadao@jyu.fi |
Scientific
Rautpohjankatu 8a (VIV227)
Jyväskylä
40700
Finland
| ORCID ID |
0000-0002-7697-2813 |
|---|---|
| Phone | +358 40 5566582 |
| taija.m.juutinen@jyu.fi |
Scientific
Rautpohjankatu 8a (VIV222)
Jyväskylä
40700
Finland
| ORCID ID |
0000-0001-8637-8853 |
|---|---|
| Phone | +358 50 4156366 |
| francesco.l.cenni@jyu.fi |
Study information
| Study design | Single-centre non-randomized study with multiple baseline design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Effects of a tailored exercise therapy intervention on physical capacities and function, neuromuscular mechanisms and cardiometabolic risk factors of children and young adults with cerebral palsy |
| Study acronym | EXECP and sub-study I-SENS |
| Study objectives | Current study hypothesis as of 26/11/2021: The primary hypothesis to be tested is gait performance: 1. The EXECP intervention will enhance gait performance by: a) increasing walking distance in the 6 minutes walking test; b) increasing ankle dorsiflexion during the swing and stance phase of gait; c) increasing maximal walking velocity, joint net moments and ranges of motion in the lower limb joints. The secondary hypotheses to be tested are: 2. Physical activity (PA) level will remain constant throughout the study. Furthermore, PA is expected to be inversely correlated with the cardiometabolic risk factors in the control period and positively correlated with the retention of the adaptations during the maintenance period. 3. The EXECP intervention will: a) increase maximal isometric and concentric torque for plantarflexors, dorsiflexors, knee extensors and flexors; b) increase torque-angle curve width (Reid et al.2010) for all four muscle actions; c) increase torque steadiness during submaximal isometric dorsiflexion; d) increase gross motor function measure (GMFM; Russel et al. 2000) score; e) not affect cardiometabolic risk factors such as arterial stiffness, sedentarism-related blood biomarkers and body adiposity. 4. The EXECP intervention will: a) increase lower limb joint flexibility (i.e. range of motion) of the trained muscle groups; b) increase triceps surae muscle passive resistance, average joint stiffness and energy (i.e. area under the torque-angle curve) during slow passive stretching. 5. The EXECP intervention will: a) decrease antagonist muscle electromyography (EMG) during maximal voluntary isometric and concentric plantarflexion and dorsiflexion; b) not change the tonic stretch reflex threshold angle ); c) not change soleus post-activation depression; d) not change the H-reflex normalized by the maximum M-wave of soleus muscle; d) increase the passive-movement evoked fields in the primary somatosensory cortex (i.e. cortical proprioceptive responses); e) increase cortico-muscular and intramuscular coherence in tibialis anterior during a submaximal isometric dorsiflexion; f) increase tibialis anterior intramuscular coherence during the swing phase of the gait cycle. No changes in any of the studied variables are expected during the 3-month control period, except if the participant is going through the growth spurt. After the 3-month maintenance period, the studied variables values are expected to be in between the control and post intervention values. All study variables are hypothesized to be different between the TD and CP groups. 6. Within the I-SENS study, the extent to which ankle joint proprioception at the cortical level is impaired in children with CP will be associated with the level of ankle joint spasticity. We hypothesize to find such an association between spasticity and cortical proprioception. 7. Within the I-SENS study, musculoskeletal properties will be quantified both in passive and active conditions, and relate to gait performance. We intend to find the relationship that explains how the altered passive muscle-tendon properties influence their active behavior during gait. 8. Within the I-SENS study, we examined spasticity, musculoskeletal properties, cortical and behavioural proprioception. We hypothesize that musculoskeletal properties will have the predominant effect on altering (reducing) the stimulation on load-sensitive afferents during gait. _____ Previous study hypothesis as of 20/06/2019: The primary hypothesis to be tested is gait performance: 1. The EXECP intervention will enhance gait performance by: a) increasing walking distance in the 6 minutes walking test; b) increasing ankle dorsiflexion during the swing and stance phase of gait; c) increasing maximal walking velocity, joint net moments and ranges of motion in the lower limb joints. The secondary hypotheses to be tested are: 2. Physical activity (PA) level will remain constant throughout the study. Furthermore, PA is expected to be inversely correlated with the cardiometabolic risk factors in the control period and positively correlated with the retention of the adaptations during the maintenance period. 3. The EXECP intervention will: a) increase maximal isometric and concentric torque for plantarflexors, dorsiflexors, knee extensors and flexors; b) increase torque-angle curve width (Reid et al.2010) for all four muscle actions; c) increase torque steadiness during submaximal isometric dorsiflexion; d) increase gross motor function measure (GMFM; Russel et al. 2000) score; e) not affect cardiometabolic risk factors such as arterial stiffness, sedentarism-related blood biomarkers and body adiposity. 4. The EXECP intervention will: a) increase lower limb joint flexibility (i.e. range of motion) of the trained muscle groups; b) increase triceps surae muscle passive resistance, average joint stiffness and energy (i.e. area under the torque-angle curve) during slow passive stretching. 5. The EXECP intervention will: a) decrease antagonist muscle electromyography (EMG) during maximal voluntary isometric and concentric plantarflexion and dorsiflexion; b) not change the tonic stretch reflex threshold angle ); c) not change soleus post-activation depression; d) not change the H-reflex normalized by the maximum M-wave of soleus muscle; d) increase the passive-movement evoked fields in the primary somatosensory cortex (i.e. cortical proprioceptive responses); e) increase cortico-muscular and intramuscular coherence in tibialis anterior during a submaximal isometric dorsiflexion; f) increase tibialis anterior intramuscular coherence during the swing phase of the gait cycle. No changes in any of the studied variables are expected during the 3-months control period, except if the participant is going through the growth spurt. After the 3-months maintenance period, the studied variables values are expected to be in between the control and post intervention values. All study variables are hypothesized to be different between the TD and CP groups. Previous study hypothesis: 1. The intervention will enhance gait performance, increase muscle strength, neuromuscular coordination and joint range of motion. 2. The intervention will increase daily physical activity levels and improve cardiometabolic risk factors |
| Ethics approval(s) | 1. Approved 13/04/2017, Ethics Committee of Central Finland Health Care District, ref: 8u/2017. 2. Amendment approved 17/04/2018 3. Amendment approved 11/04/2019 (added 23/07/2020) 4. Amendment approved 21/09/2021 (added 26/11/2021) |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Current intervention as of 26/11/2021: The EXECP exercise therapy intervention will have two to three supervised sessions per week during 12 weeks. The intervention will be tailored to address deficits identified by instrumented gait analysis, strength and flexibility tests. The intervention will include: 1. Strength training for the lower limb and trunk muscles (ankle plantar flexors and dorsiflexors, knee, hip and trunk flexors and extensors). 2. Flexibility training for lower limb muscles diagnosed short (e.g. hip and knee flexors, hip adductors) 3. Inclined treadmill walking All sessions will have 90 minutes of duration and will be interspaced by a minimum of 48 hours. For participants with CP, the study starts with a familiarization session, then 1 week later the pre-test 1. After the control period (3 months), the pre-test 2 is done and the intervention period (three months) starts. At the end of the intervention period, post-test 1 is done, and after the end of the maintenance period (3 months) the study is finalized with post-test 2. There is no intervention on the control and maintenance periods. Pre-tests 1 and 2, and Post-tests 1 and 2 are similar, consisting of three testing sessions in which most research variables will be collected (only exception is Post-test 2, in which there will be no magnetoencephalography measurements). Physical activity data will be collected in each of the three periods, during normal daily living. For control participants, only the control period will be performed, meaning one familiarization session, and two testing sessions three month apart (Pre-tests 1 and 2). Physical activity data will be collected during this period. During the I-SENS sub-study, both CP and control participants will be invited for an additional visit to the laboratory where musculoskeletal properties, gait analysis, and behavioral proprioception will be assessed. _____ Previous intervention as of 20/06/2019: The EXECP exercise therapy intervention will have two to three supervised sessions per week during 12 weeks. The intervention will be tailored to address deficits identified by instrumented gait analysis, strength and flexibility tests. The intervention will include: 1. Strength training for the lower limb and trunk muscles (ankle plantar flexors and dorsiflexors, knee, hip and trunk flexors and extensors). 2. Flexibility training for lower limb muscles diagnosed short (e.g. hip and knee flexors, hip adductors) 3. Inclined treadmill walking All sessions will have 90 minutes of duration and will be interspaced by a minimum of 48 hours. _____ Previous intervention: For participants with Cerebral Palsy (CP), there is a three month control period, followed by a three month intervention period, followed by a three month maintenance period. For participants in the control group (typically developing participants), there is a three month control period only (at the same time as those in the CP group undergo their control period. The exercise therapy intervention will have two to three supervised sessions per week during 12 weeks. The intervention will be tailored to address deficits identified by instrumented gait analysis, strength and flexibility tests. The intervention will include: 1. Strength and flexibility training for the main lower limb muscles (quadriceps, hamstrings, triceps surae, tibialis anterior, hip flexors, extensors and abductors) 2. Skill and functional training (e.g. balancing and force matching exercises, climbing stairs) 3. Treadmill walking 4. Various sport activities (e.g. swimming, football, volleyball) All sessions will have 60 to 90 minutes of duration and will be interspaced by a minimum of 48 hours For participants with CP, the study starts with a familiarization session, then 1 week later the pre-test 1. After the control period (3 months), the pre-test 2 is done and the intervention period (three months) starts. At the end of the intervention period, post-test 1 is done, and after the end of the maintenance period (3 months) the study is finalized with post-test 2. There is no intervention on the control and maintenance periods. Pre-tests 1 and 2, and Post-tests 1 and 2 are similar, consisting of three testing sessions in which most research variables will be collected (only exception is Post-test 2, in which there will be no magnetoencephalography measurements). Physical activity data will be collected in each of the three periods, during normal daily living. For control participants, only the control period will be performed, meaning one familiarization session, and two testing sessions three month apart (Pre-tests 1 and 2). Physical activity data will be collected during this period. |
| Intervention type | Other |
| Primary outcome measure | Current primary outcome measure as of 20/06/2019: Gait performance is assessed using a six minute walking test. Gait kinetics/kinematics/mechanical efficiency is assessed using Vicon cameras, force plates and a heart rate monitor at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group. Previous primary outcome measure: Gait performance is assessed using a 6 minutes walking test at baseline (pre-test 1), 3 (pre-test 2), 6 (post-test 1) and 9 (post-test 2) months for participants with CP and at baseline and 3 months for control participants. |
| Secondary outcome measures | Current secondary outcome measures as of 29/11/2021: 1. Physical activity levels are measured using electromyography and accelerometry during 7 days of normal daily living at all three periods (control, intervention and maintenance) 2. Muscle strength is assessed using Isokinetic dynamometry at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 3. Body composition is assessed using Inbody at pre-tests 1 and 2, and post-test for the CP group and pre-tests 1 and 2 for the control group 4. Blood biomarkers, arterial stiffness is assessed through blood sampling and arteriography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 5. H-reflex and, Post-activation depression is assessed through nerve stimulation and Electromyography at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 6. Proprioceptive responses and corticomuscular coherence is assessed through Magnetoencephalography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 7. Spasticity is assessed using the tonic stretch reflex threshold at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 8. Joint Flexibility is assessed using an Isokinetic dynamometer coupled with a linear potentiometer at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 9. Motor Function is assessed using the Gross Motor Function Measure (GMFM-66) at pre-test 2 and post-test 1 for the CP group 10. Motivational factors influencing physical activity in the intervention will be assessed using a questionnaire at the familiarization session 11. Motivational factors influencing physical activity participation will be assessed using a questionnaire at 6 and 9 months 12. Parents' motivational factors towards their children's physical activity participation will be explored using a questionnaire at the familiarization session and 6 months 13. Passive musculoskeletal properties (from medial and lateral gastrocnemius, soleus and Achilles tendon) are measured using 3D freehand ultrasonography (2D ultrasound system and motion tracking system are synchronized and spatially calibrated for implementing this technique) and shear wave elastography, in static ankle joint positions at a single timepoint between January 2022 and December 2022 14. Active musculoskeletal properties (from belly and fascicles of medial gastrocnemius, and Achilles tendon) are measured with 2D ultrasound imaging recorded simultaneously during 3D gait analysis at a single timepoint between January 2022 and December 2022 15. Behavioural proprioception is measured using a silent and motorized ankle-movement actuator to slightly move the joint with different angular velocities at a single timepoint between January 2022 and December 2022. The subjects will be asked to push a button when the movement is perceived. _____ Previous secondary outcome measures as of 26/11/2021: 1. Physical activity levels are measured using electromyography and accelerometry during 7 days of normal daily living at all three periods (control, intervention and maintenance) 2. Muscle strength is assessed using Isokinetic dynamometry at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 3. Body composition is assessed using Inbody at pre-tests 1 and 2, and post-test for the CP group and pre-tests 1 and 2 for the control group 4. Blood biomarkers, arterial stiffness is assessed through blood sampling and arteriography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 5. H-reflex and, Post-activation depression is assessed through nerve stimulation and Electromyography at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 6. Proprioceptive responses and corticomuscular coherence is assessed through Magnetoencephalography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 7. Spasticity is assessed using the tonic stretch reflex threshold at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 8. Joint Flexibility is assessed using an Isokinetic dynamometer coupled with a linear potentiometer at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 9. Motor Function is assessed using the Gross Motor Function Measure (GMFM-66) at pre-test 2 and post-test 1 for the CP group 10. Motivational factors influencing physical activity in the intervention will be assessed using a questionnaire at the familiarization session 11. Motivational factors influencing physical activity participation will be assessed using a questionnaire at 6 and 9 months 12. Parents' motivational factors towards their children's physical activity participation will be explored using a questionnaire at the familiarization session and 6 months 13. Passive musculoskeletal properties (from medial and lateral gastrocnemius, soleus and Achilles tendon) are measured using 3D freehand ultrasonography (2D ultrasound system and motion tracking system are synchronized and spatially calibrated for implementing this technique) and shear wave elastography, in static ankle joint positions 14. Active musculoskeletal properties (from belly and fascicles of medial gastrocnemius, and Achilles tendon) are measured with 2D ultrasound imaging recorded simultaneously during 3D gait analysis 15. Behavioural proprioception is measured using a silent and motorized ankle-movement actuator to slightly move the joint with different angular velocities. The subjects will be asked to push a button when the movement is perceived. _____ Previous secondary outcome measures as of 20/06/2019: 1. Physical activity levels are measured using electromyography and accelerometry during 7 days of normal daily living at all three periods (control, intervention and maintenance) 2. Muscle strength is assessed using Isokinetic dynamometry at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 3. Body composition is assessed using Inbody at pre-tests 1 and 2, and post-test for the CP group and pre-tests 1 and 2 for the control group 4. Blood biomarkers, arterial stiffness is assessed through blood sampling and arteriography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 5. H-reflex and, Post-activation depression is assessed through nerve stimulation and Electromyography at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 6. Proprioceptive responses and corticomuscular coherence is assessed through Magnetoencephalography at pre-tests 1 and 2, and post-test 1 for the CP group and pre-tests 1 and 2 for the control group 7. Spasticity is assessed using the tonic stretch reflex threshold at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 8. Joint Flexibility is assessed using an Isokinetic dynamometer coupled with a linear potentiometer at pre-tests 1 and 2, and post-tests 1 and 2 for the CP group and pre-tests 1 and 2 for the control group 9. Motor Function is assessed using the Gross Motor Function Measure (GMFM-66) at pre-test 2 and post-test 1 for the CP group Previous secondary outcome measures: 1. Physical activity levels are measured using electromyography and accelerometry during 7 days of normal daily living at all three periods (control, intervention and maintenance) 2. Muscle strength is assessed using Isokinetic dynamometry at baseline (pre-test 1), 3 (pre-test 2), 6 (post-test 1) and 9 (post-test 2) months for participants with CP and at baseline and 3 months for control participants 3. Gait kinetics/kinematics/mechanical efficiency is assessed using Vicon cameras, force plates and a heart rate monitor at baseline (pre-test 1), 3 (pre-test 2), 6 (post-test 1) and 9 (post-test 2) months for participants with CP and at baseline and 3 months for control participants 4. Body composition is assessed using Inbody at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 5. Blood biomarkers, arterial stiffness is assessed through blood sampling and arteriography at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 6. H-reflex, Post-activation depression is assessed through nerve stimulation and Electromyography at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 7. Proprioceptive responses and corticomuscular coherence is assessed through Magnetoencephalography at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 8. Spasticity is assessed using the tonic stretch reflex threshold at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 9. Joint Flexibility is assessed using a Isokinetic dynamometer coupled with a linear potentiometer at baseline, 3, 6 and 9 months for participants with CP and at baseline and 3 months for control participants 10. Motor Function is assessed using the Gross Motor Function Measure (GMFM-66) at baseline, 3, 6 and 9 months for participants with CP 11. Perceived competence, relatedness and autonomy are assessed using questionnaires at the familiarization session, 6 and 9 months 12. Parent’s intentions and attitudes towards physical activity of their children are assessed using a questionnaire at the familiarization session and 6 months |
| Overall study start date | 12/09/2016 |
| Completion date | 31/01/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Lower age limit | 9 Years |
| Upper age limit | 24 Years |
| Sex | Both |
| Target number of participants | 24 in each group |
| Total final enrolment | 36 |
| Key inclusion criteria | Current participant inclusion criteria as of 20/06/2019: Experimental group: 1. Spastic CP (diplegic or hemiplegic) 2. Male and Female 3. Age range of 9 to 24 years old 4. Gross Motor Function Classification System (Palisano et al. 2008) levels 1 to 3 Control group: 1. Typically developing 2. Male and Female 3. Age range of 9 to 24 years old Previous participant inclusion criteria: Experimental group: 1. Spastic CP (diplegic or hemiplegic) 2. Male and Female 3. Age range of 10 to 23 years old 4. Gross Motor Function Classification System (Palisano et al. 2008) levels 1 to 3 Control group: 1. Typically developing 2. Male and Female 3. Age range of 10 to 23 years old |
| Key exclusion criteria | 1. Pharmacological treatments (e.g. intrathecal baclofen, botullinum toxin) in the last 6 months 2. Surgical procedures in the last 6 months 3. Selective dorsal rhyzotomy 4. Dystonia 5. Inability to understand basic instructions 6. Current utilization of serial casting 7. Inability to stand with the sole of the foot flat on the floor 8. Participation in the past 3 months in a structured physical training program *Exclusion criteria 1 to 3 may be accepted as a case study (added 20/06/2019). |
| Date of first enrolment | 24/04/2017 |
| Date of final enrolment | 15/12/2020 |
Locations
Countries of recruitment
- Finland
Study participating centre
Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland
Sponsor information
University/education
Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland
| Phone | +358 14 260 2011 |
|---|---|
| taija.m.juutinen@jyu.fi | |
| Website | https://www.jyu.fi/sport/en/ |
"ROR" |
https://ror.org/05n3dz165 |
Funders
Funder type
University/education
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Jyväskylä, Jyväskylä University, University of Jyväskylä - Finland, University of Jyväskylä, Finland, JYU
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Olvi Foundation
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Ellen and Artturi Nyyssönen Foundation
- Location
- Finland
Government organisation / Universities (academic only)
- Alternative name(s)
- Suomen Akatemia, Finlands Akademi, Academy of Finland, AKA
- Location
- Finland
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Jane and Aatos Erkko Foundation, Jane och Aatos Erkkos stiftelse, J&AE
- Location
- Finland
No information available
Results and Publications
| Intention to publish date | 30/09/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | The results will be published in international high-impact peer-reviewed journals. |
| IPD sharing plan | Current IPD sharing plan: The datasets generated during and/or analysed during the current study will be stored in a publicly available repository at https://doi.org/10.17605/OSF.IO/4KBJH or https://osf.io/4kbjh/. The type of data stored: raw data (spike files .smr), processed files (matlab .mat files), analysis code in matlab (.mlx or .m). Data was fully anonymized by destroying the only document that had personal information and subject research ID (consent form). Previous IPD sharing plan: Participant-level data contains sensible information and according to the Finnish Data Protection Act cannot be shared. All data files will be stored on the server of the University of Jyväskylä and protected by individual usernames and passwords. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 26/02/2021 | 01/03/2021 | Yes | No |
| Interim results article | 23/11/2022 | 12/12/2022 | Yes | No | |
| Dataset | 18/09/2023 | No | No | ||
| Results article | 07/08/2023 | 18/09/2023 | Yes | No | |
| Results article | 23/11/2022 | 18/09/2023 | Yes | No | |
| Results article | Cardiometabolic risk factors | 21/10/2024 | 24/10/2024 | Yes | No |
| Results article | Physical activity | 01/05/2025 | 01/05/2025 | Yes | No |
Editorial Notes
01/05/2025: Publication reference added.
24/10/2024: Publication reference added.
11/10/2023: IPD sharing statement updated.
18/09/2023: Publication references and dataset added.
12/12/2022: The following changes were made to the trial record:
1. Publication reference added.
2. The overall end date was changed from 31/12/2022 to 31/01/2023.
29/11/2021: The following changes have been made:
1. The scientific contacts have been added and the plain English summary updated accordingly.
2. The secondary outcome measures have been changed.
26/11/2021: The following changes have been made:
1. The intervention has been changed.
2. The ethics approval has been updated.
3. The overall trial end date has been changed from 31/03/2021 to 31/12/2022.
4. H2020 Marie Skłodowska-Curie Actions has been added to the funders.
5. I-SENS has been added to the acronyms.
6. The study hypothesis has been changed.
7. The secondary outcome measures have been changed.
8. The trial websites have been added.
9. The plain English summary has been updated to reflect the above changes.
22/11/2021: Internal review.
01/03/2021: Publication reference added.
11/12/2020: The following changes were made to the trial record:
1. The overall trial end date was changed from 15/09/2021 to 31/03/2021.
2. Total final enrolment number added.
09/09/2020: Internal review.
03/09/2020: The overall trial end date was changed from 30/09/2022 to 15/09/2021 and the plain English summary was updated accordingly.
01/09/2020: The recruitment end date was corrected from 15/02/2020 to 15/12/2020.
2. The overall end date was changed from 15/02/2020 to 15/12/2020.
28/08/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/12/2021 to 15/02/2020.
2. The target number of participants was changed from "18 in each group" to "24 in each group".
24/07/2020: The funder "Emil Aaltonen Foundation" was removed from the plain English summary.
23/07/2020: The following changes were made to the trial record:
1. The ethics approval was updated.
2. The funder "Emil Aaltonen Foundation" was removed.
08/11/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 05/11/2019 to 30/12/2021.
2. The overall end date was changed from 25/08/2020 to 30/09/2022.
3. The intention to publish date was changed from 31/08/2019 to 30/09/2023.
4. The plain English summary was updated to reflect these changes.
20/06/2019: The following changes were made to the trial record:
1. The intention to publish date was changed from 31/12/2019 to 31/08/2019.
2. The participant inclusion criteria were changed.
3. The participant exclusion criteria were changed.
4. The target number of participants was changed from "24 in each group" to "18 in each group".
5. The primary outcome measure was changed.
6. The secondary outcome measures were changed.
7. The interventions were changed.
8. The study design was changed from "Single-centre non-randomised study with multiple baselines" to "Single-centre non-randomised study with multiple baseline design"
9. The ethics approval was updated to include an amendment.
10. The study hypothesis was changed.
11. The scientific title was changed from "Effects of a tailored exercise therapy intervention on physical capacity and function, neuromuscular mechanisms and cardiometabolic risk factors of children and young adults with cerebral palsy" to "Effects of a tailored exercise therapy intervention on physical capacities and function, neuromuscular mechanisms and cardiometabolic risk factors of children and young adults with cerebral palsy".
12. The following funders were added: Olvi Foundation, Ellen and Artturi Nyyssönen Foundation, Academy of Finland, Jane and Aatos Erkko Foundation, and Eemil Aaltonen Foundation.
13. The plain English summary was updated to reflect these changes.
