Plain English Summary
Background and study aims
Cerebral palsy (CP) is the medical term used to describe a number of neurological conditions that affect movement and co-ordination. It is caused by a damage to the parts of the brain responsible for controlling muscles. This can be due to a number of reasons including infections caught by the mother during pregnancy, a difficult birth, bleeding in the baby’s brain and mutations in the genes that affect brain development. Symptoms of CP include muscle stiffness or floppiness, muscle weakness, random and uncontrolled body movements and balance and co-ordination problems. Being able to walk and function independently becomes especially important as children enter adolescence and want to take part in activities outside family life. Just as young adults with CP are becoming more independent, they can experience deterioration in their walking ability making it difficult for them to participate in everyday life. One reason for this deterioration is that it takes more effort for people with CP to walk than people without CP. The increased effort is possibly due to people with CP having less control over their muscles and because the mechanical characteristics of their muscles and tendons are different from people without CP. Resistance training can be used to treat people with CP. Improved muscle strength and altered mechanical properties of muscle and tendons as a result of resistance training could reduce the effort of walking. This in turn could prevent deterioration in walking function and encourage physical activity. The aim of this study is to investigate the effectiveness and acceptability of resistance training in adolescents with CP.
Who can participate?
Adolescents (aged 10-19) with cerebral palsy that are able to walk independently.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 carry out a set of specific exercises including resistance training. Those in group 2 continue with their usual care, provided that this does not include resistance training. The researchers then make assessments in order to answer three important questions: Firstly, is resistance training feasible and acceptable in adolescents with CP? Secondly, does it make walking easier and increase physical activity and participation in everyday life?
What are the possible benefits and risks of participating?
The information collected may help in deciding on the best treatment to provide teenagers with cerebral palsy. Participants in the resistance training group may find that their muscles get stronger and they may find it easier to walk. Possible risks include muscle soreness after the assessments or after the exercises. It may also be painful when the sticky tape used to attach sensors to the participants legs and feet to record their movement, video their muscles and measure how much their muscles are working is removed.
Where is the study run from?
Brunel University London (UK)
When is the study starting and how long is it expected to run for?
August 2015 to July 2018
Who is funding the study?
1. Action Medical Research (UK)
2. Chartered Society of Physiotherapy Charitable Trust (UK)
Who is the main contact?
Dr Jennifer Ryan
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jennifer Ryan
ORCID ID
http://orcid.org/0000-0003-3768-2132
Contact details
Brunel University
Clinical Sciences
Mary Seacole Building
Uxbridge
UB8 3PH
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
19112
Study information
Scientific title
An evaluation of the feasibility, acceptability and efficacy of resistance training in adolescents with cerebral palsy: a randomised controlled trial
Acronym
Study hypothesis
The aim of this study is to investigate the effectiveness and acceptability of resistance training in adolescents with cerebral palsy (CP)
Ethics approval
Brunel University London’s Department of Clinical Sciences’ Research Ethics Committee and the NRES Committee London – Surrey Borders, ref: 15/LO/0843
Study design
Randomised; Interventional; Design type: Screening
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Children, Musculoskeletal disorders; Subtopic: All Diagnoses, Musculoskeletal (all Subtopics); Disease: Musculoskeletal, All Diseases
Intervention
Progressive resistance training will be performed three times per week for 10 weeks; two sessions will be carried out at participants’ homes and one will be a group session carried out in participants’ local physiotherapy departments or gyms. Single-joint plantarflexor exercises will be based on individual strength capacities, to ensure the participant can perform a minimum of eight and a maximum of 12 repetitions, which equates to approximately 65-80% of 1-repetition maximum. To minimise injury risk in adolescents unaccustomed to strength training, the number of repetitions completed during the first training session will depend on their rating of perceived exertion recorded in a familiarisation session. Each group session will be managed by a physiotherapist and will include a 5-10 minute aerobic warm-up of aerobic activity and a 5-10 minute cool-down consisting of aerobic activity and plantarflexor stretches. Adolescents will perform two circuits of four stations: two stations of plantarflexor exercises and two stations of unrelated activities such as basketball shooting or throwing and catching a ball with a partner, to help maintain participant motivation. Plantarflexor exercises will include standing heel raises with or without added resistance from a weighted vest, plantarflexor contractions against the footplate of a recumbent calf-raise machine, and plantarflexor contractions against a Thera-Band resistance band in long-sitting. Home exercises will consist of four sets of 8-12 repetitions of single-leg heel raises with or without a weighted vest, or plantarflexor exercises using a Thera-Band resistance band, at the intensity prescribed in the class. Participants will record the number of reps and sets they perform of each exercise, their rate of perceived exertion on a scale of 0-10, their level of pain on a scale of 0-10, and any potentially related or unrelated adverse effects after each session using a patient support tool. This information will be transmitted directly to the research team. Attendance at the group sessions will also be recorded. All participants, including those in the control group, will be instructed to continue their normal activities. All participants will also be instructed to continue with their usual physiotherapy programme, provided it does not include progressive resistance training.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Gait efficiency measured using indirect calorimetry at 0, 10 and 22 weeks
Secondary outcome measures
1. Physical activity measured using accelerometry
2. Participation measured using Assessment of Life Habits questionnaire (Life-H)
3. Gross Motor Function measured using components D and E of Gross Motor Function Measure (GMFM) and 10m walking trial
4. Muscle strength measured using isokinetic dynamometry
5. Muscle activity during dynamometry and treadmill walking measured using EMG
6. Muscle and tendon force measured using isokinetic dynamometry and ultrasonography
7. Muscle and tendon length measured using ultrasonography and motion analysis
8. Muscle and tendon stiffness measured using ultrasonography and motion analysis
9. Muscle, tendon and fascicle strain measured using ultrasonography
10. Muscle and tendon cross-sectional area measured using ultrasonography
11. Quality of life measured using EQ-5D-Y and CHU 9D
All measured at 0, 10 and 22 weeks
Deleted 04/08/2016:
Movement quality measured using Quality Function Measure
Overall trial start date
03/08/2015
Overall trial end date
31/12/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adolescents with cerebral palsy aged 10-19 years (amended from 12-19 years on 12/07/2016)
2. The ability to walk independently with or without a mobility aid
3. The ability to activate the ankle plantarflexors
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 60; UK Sample Size: 60
Total final enrolment
64
Participant exclusion criteria
1. Orthopaedic surgery in the past year
2. Botulinum toxin type A (Botox) injections or serial casting in the past 6 months
3. Receiving intrathecal baclofen
4. Unable to comply with the protocol
Recruitment start date
21/09/2015
Recruitment end date
01/07/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brunel University
Clinical Sciences
Mary Seacole Building
Uxbridge
UB8 3PH
United Kingdom
Funders
Funder type
Charity
Funder name
Action Medical Research
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
Chartered Society of Physiotherapy Charitable Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
1. Trial protocol: December 2016
2. The effect of resistance training on gait efficiency, physical activity and participation in adolescents with cerebral palsy: December 2018
3. The effect of resistance training on muscle-tendon mechanics in adolescents with cerebral palsy: December 2018
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available publicly, as consent was not obtained to publish the anonymised data.
Intention to publish date
31/12/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2016 protocol in https://www.ncbi.nlm.nih.gov/pubmed/27707836
2020 results in https://pubmed.ncbi.nlm.nih.gov/32588919/ (added 30/06/2020)