Does a 10-week physiotherapy programme, using interactive exercise equipment, improve balance and walking in children with cerebral palsy aged 4-18 years when compared to usual care?
| ISRCTN | ISRCTN80878394 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80878394 |
| IRAS number | 269948 |
| Secondary identifying numbers | ACCEPT Study protocol version 2_11.09.2020, IRAS 269948, CPMS 44763 |
- Submission date
- 08/01/2021
- Registration date
- 11/01/2021
- Last edited
- 16/10/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Children with cerebral palsy (CP) frequently have difficulties walking. Walking can be very tiring and difficulties with balance make everyday tasks much harder. This can affect a child’s self-confidence and how children interact with other peers.
Home exercise programmes are designed to help with such problems but children often do not want to do these exercises. When a child’s muscles get stiff and tight they may need costly and burdensome surgery to lengthen the muscles. Where there are several problems that affect movement, it can be difficult for physiotherapists to develop effective home-based treatments.
A novel piece of equipment, similar to a cross-trainer, has been developed that allows the child to do therapy by playing motivating computer games using their leg movement. The device supports the child in a standing position while they work on improving standing posture, balance, strength and mobility in a fun and motivating way. The device uses motors at the ankles and knees to assist or resist the movements that children have difficulties performing. It allows children to carry out precise movements to control a series of interactive, fun computer games. A small study suggested that using the interactive trainer intensively over a 10-week period results in some improvement in children’s walking. This study aims to carry out preliminary work to find out if it is possible to undertake a major study to test the effectiveness of this intervention.
Who can participate?
Children with cerebral palsy (CP) aged 4-18 who are able to walk
What does the study involve?
In the study, children with CP will be allocated at random using a computer to either a group using the interactive trainer or usual physiotherapy management. This will ensure both groups are similar in terms of the age and level of physical impairment at the start of the trial. Twenty children will use the interactive trainer and twenty children will have usual care. The interactive trainer will be based at either home, local school or physiotherapy department and will be set up to the individual child’s training needs by their physiotherapist. Children will then train three times per week, helped by their physiotherapy or teaching assistant. The ‘usual care’ group will undertake home-based exercises. The content of the usual care exercises will be defined and based on current guidelines and the consensus opinion of ten expert physiotherapists.
Training in both groups will take place over 10 weeks. Children will be assessed at the beginning of the study, after 10 weeks of therapy, and 3 months after finishing the training. Measures will include walking and balance ability, and other factors such as strength and overall satisfaction.
Finally, participants’ views will be sought on whether the novel intervention and the usual care exercises were comfortable and motivating. Six children and their parents from each group will be selected and invited to be interviewed. These children will receive an electronic tablet and will be asked to indicate daily how they found the training and how they felt. Over the 10-week training period they will be asked to take 5-20 photos that they feel represent their experiences of their exercise programme. The photos will guide the discussion during an interview to gain a deeper knowledge of their experiences. Parents will also be interviewed about the impact of the exercise programme on family life as well as the feasibility of this study. The researchers will interview a group of physiotherapists about their experiences of the study. The results of this study will be brought together to determine how to design future clinical trials.
What are the possible benefits and risks of taking part?
The results of this study will show whether it is feasible to run a large trial to test whether the interactive trainer is more effective than usual care. Children may benefit from treatments in either group. Children may find the tests tiring to complete. They may feel some fatigue or muscle soreness following strength training.
Where is the study run from?
University of Plymouth (UK)
When is the study starting and how long does it go on for?
September 2019 to August 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK), ref. ICA-CDRF-2017-03-041
Who is the main contact?
Rachel Rapson
rachel.rapson@nhs.net
Contact information
Public
Torbay and South Devon NHS Foundation Trust
Vowden Hall
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom
 ORCID ID |
0000-0001-8265-5358 |
|---|---|
| Phone | +44 (0)7971246592 |
| rachel.rapson@nhs.net |
Study information
| Study design | Mixed methods feasibility randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Participant information sheet | https://www.plymouth.ac.uk/research/a-novel-interactive-training-device-to-improve-walking-ability-and-quality-of-life-for-children-with-cerebral-palsy-trial-accept-study |
| Scientific title | A multi-centre feasibility randomised control trial of a physiotherapy programme using interactive exercise equipment to improve balance in ambulant children with cerebral palsy |
| Study acronym | ACCEPT |
| Study hypothesis | Training on the Happy Rehab™ interactive device improves outcomes of dynamic balance when compared to usual physiotherapy care. |
| Ethics approval(s) |
Approved 03/02/2020, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, United Kingdom; +44 (0)1224 558458; nosres@nhs.net), ref: 20/NS/0018 |
| Condition | Ambulant children with cerebral palsy GMFCS I-III |
| Intervention | The objective of the trial is to assess the feasibility of conducting an RCT evaluating the effect of interactive exercise equipment on balance and walking for children with cerebral palsy, the feasibility of the intervention and investigate participant views of taking part in the trial. Participants will be randomised on a 1:1 using minimisation criteria based on age and gross motor function classification to either the intervention or usual physiotherapy care. The intervention is 20 minutes training using a Happy Rehab™ interactive training device for 20 minutes, 3 times per week for 10 weeks. The device will be used in the home and set up by the usual treating physiotherapist. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Happy Rehab™ |
| Primary outcome measure | Balance measured by two potential primary outcome measures at 0, 10 and 20 weeks: 1. Next step test of dynamic balance, specifically the medio-lateral and antero-posteriori movement of the centre of mass and stepping error 2. Pediatric Balance Scale |
| Secondary outcome measures | 1. Walking kinematics measured using CODAmotion gait analysis at 0, 10 and 20 weeks 2. Muscle strength of quadriceps, hamstrings, and gastrocnemius and hip abductors measured using a handheld dynamometer (three measurements) at 0, 10 and 20 weeks 3. Passive range of movement and spasticity measured using the modified Tardieu scale of quadriceps, hamstrings, gastrocnemius and hip adductors using a goniometer (three measurements) at 0, 10 and 20 weeks 4. Participation measured using the Canadian Occupational Performance Measure (COPM) at 0, 10 and 20 weeks 5. Quality of life measured using CHU-9D at 0, 10 and 20 weeks |
| Overall study start date | 01/09/2019 |
| Overall study end date | 01/08/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 16 |
| Participant inclusion criteria | 1. Diagnosis of cerebral palsy Gross Motor Function Classification Scale (GMFCS) I-III 2. Aged 4-18 years 3. Leg weakness (≤4/5 on the MRC muscle strength rating scale) in at least one muscle group 4. Leg hypertonia (≥1 on the Tardieu scale fast stretch) in at least one muscle group 5. Ability to interact with a computer game using a mouse or joystick |
| Participant exclusion criteria | 1. Selective dorsal rhizotomy or multi-level orthopaedic surgery within the last 12 months 2. Soft tissue surgery in lower limbs in the last 6 months 3. Anti-spasticity botulinum toxin injections within the previous 3 months 4. Training with the Happy Rehab™ in the last 4 months |
| Recruitment start date | 25/01/2021 |
| Recruitment end date | 31/12/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Newton Road
Torquay
TQ2 7BA
United Kingdom
Scott Business Park
Deacon Park Road
Plymouth
PL2 2PQ
United Kingdom
Sponsor information
University/education
Drake Circus
Plymouth
PL4 8AA
England
United Kingdom
| Phone | +44 (0)1752600600 |
|---|---|
| plymouth.sponsor@plymouth.ac.uk | |
| Website | https://www.plymouth.ac.uk/ |
"ROR" |
https://ror.org/008n7pv89 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| Publication and dissemination plan | Planned publication in Child Health and Development |
| IPD sharing plan | The participant-level data will be anonymised and available for access via PEARL at the University of Plymouth after study close down. Participants will be asked for their consent to share this anonymised data. Interested parties can contact Rachel.rapson@plymouth.ac.uk or access it via the PEARL repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version V2 | 11/09/2020 | 11/01/2021 | No | No |
| Protocol article | 30/05/2022 | 08/06/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN80878394_PROTOCOL_V2_11Sep20.docx
- Uploaded 11/01/2021
Editorial Notes
16/10/2023: Vranch House Charity and Royal Cornwall Hospitals NHS Trust were removed from the list of study participating centres.
09/05/2022: The final enrolment number has been added.
08/06/2022: Publication reference added.
10/01/2022: The following changes have been made:
1. The recruitment end date has been changed from 01/12/2021 to 31/12/2021.
2. The total target enrolment and the target number of participants have been changed from 40 to 20.
11/01/2021: Uploaded protocol Version 2, 11 September 2020 (not peer reviewed).
08/01/2021: Trial's existence confirmed by North of Scotland Research Ethics Committee (1).
