Condition category
Nervous System Diseases
Date applied
18/04/2017
Date assigned
21/04/2017
Last edited
08/11/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Current plain English summary as of 20/06/2019:
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 programme 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 wellbeing. 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.

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. 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 September 2022 (updated 08/11/2019, previously: August 2020)

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. Eemil Aaltonen Foundation (Finland)

Who is the main contact?
Mr Pedro Valadao
pedro.valadao@jyu.fi

Previous plain English summary:
Background and study aims
Cerebral palsy (CP) is a term for a number of conditions that affect movement and co-ordination. It occurs when there is a problem in the parts of the brain responsible for controlling muscles. This can be due to abnormal development of the brain or damage caused before, during or after birth. CP leads to a range of symptoms, including muscle stiffness or weakness, random and uncontrolled body movements and balance and coordination problems. Problems with walking (gait) are the most common problems seen in children with CP. It has been shown that children and adults with CP are less physically active than those who have developed normally. This in turn leads to lower physical fitness, and risks of developing a range of health conditions. There is a lot of evidence to show that exercise programmes (e.g. strength training, aerobic training, functional skill training) are able to enhance physical capacity, functionality and wellbeing in people with CP. The aim of this study is to look at the effects of an individualised exercise programme on children and young people with CP.

Who can participate?
People with CP aged 10 to 23 years old and typically developing people of the same age.

What does the study involve?
There are three parts to this study. Firstly, there is a three month “control period”, in which participants continue as normal. Secondly, there is a three month “intervention period”, in which participants take part in the exercise programme. Thirdly, there is a three month “maintenance period” during which participants continue as normal. Those with CP take part in all three periods, and typically developing participants take part in only 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; skill and functional training, such as balancing and climbing stairs; treadmill walking; and various sport activities, such as swimming, football and volleyball. Before and after the three month control period and the three month maintenance period, participants complete a range of assessments and questionnaires to look at their physical capacity, functionality and wellbeing. In addition, for one week during each study period, participants wear a special device to record their physical activity.

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 further health problems. There are no notable risks involved with taking part other than the general risks associated with exercising such as muscle soreness, tiredness or increased 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 August 2020

Who is funding the study?
University of Jyväskylä (Finland)

Who is the main contact?
Mr Pedro Valadao
pedro.valadao@jyu.fi

Trial website

Contact information

Type

Public

Primary contact

Mr Pedro Valadao

ORCID ID

http://orcid.org/0000-0003-0720-7103

Contact details

University of Jyväskylä
Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland
+358 40 145 9280
pedro.valadao@jyu.fi

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

8U/2017

Study information

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

Acronym

EXECP

Study hypothesis

Current 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

1. Approved 13/04/2017, Ethics Committee of Central Finland Health Care District, ref: 8u/2017.
2. Amendment approved on 17.04.2018.

Study design

Single-centre non-randomised study with multiple baseline design

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cerebral Palsy

Intervention

Current interventions 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 interventions:
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

Phase

Drug names

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 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 trial start date

12/09/2016

Overall trial end date

30/09/2022

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

18 in each group

Participant 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).

Recruitment start date

24/04/2017

Recruitment end date

30/12/2021

Locations

Countries of recruitment

Finland

Trial participating centre

University of Jyväskylä
Neuromuscular Research Center Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland

Sponsor information

Organisation

University of Jyväskylä

Sponsor details

Faculty of Sport and Health Sciences
Jyväskylä
40014
Finland
+358 14 260 2011
taija.m.juutinen@jyu.fi

Sponsor type

University/education

Website

https://www.jyu.fi/sport/en/

Funders

Funder type

University/education

Funder name

Jyväskylän Yliopisto

Alternative name(s)

University of Jyväskylä, JYU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Finland

Funder name

OLVI-Säätiö

Alternative name(s)

Olvi Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Finland

Funder name

Ellen ja Artturi Nyyssösen Säätiö

Alternative name(s)

Ellen and Artturi Nyyssönen Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both publically funded and privately funded)

Location

Finland

Funder name

Academy of Finland

Alternative name(s)

Suomen Akatemia, Finlands Akademi

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

Finland

Funder name

Jane ja Aatos Erkon Säätiö

Alternative name(s)

Jane and Aatos Erkko Foundation, J&AE

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Funder name

Emil Aaltosen Säätiö

Alternative name(s)

Emil Aaltonen Foundation

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Finland

Results and Publications

Publication and dissemination plan

The results will be published in international high-impact peer-reviewed journals.

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.

Intention to publish date

30/09/2023

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.