Condition category
Nervous System Diseases
Date applied
08/01/2021
Date assigned
11/01/2021
Last edited
11/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

Trial website

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

Contact information

Type

Public

Primary contact

Mrs Rachel Rapson

ORCID ID

http://orcid.org/0000-0001-8265-5358

Contact details

Torbay and South Devon NHS Foundation Trust
Vowden Hall
Torbay Hospital
Torquay
TQ2 7AA
United Kingdom
+44 (0)7971246592
rachel.rapson@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ACCEPT Study protocol version 2_11.09.2020, IRAS 269948, CPMS 44763

Study information

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

Acronym

ACCEPT

Study hypothesis

Training on the Happy Rehab interactive device improves outcomes of dynamic balance when compared to usual physiotherapy care.

Ethics approval

Approved 03/02/2020, North of Scotland Research Ethics Committee (1) (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; nosres@nhs.net), REC ref: 20/NS/0018

Study design

Mixed methods feasibility randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Home

Trial type

Treatment

Patient 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

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 a 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

Phase

Not Applicable

Drug names

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 trial start date

01/09/2019

Overall trial end date

01/08/2022

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

40

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

01/12/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Torbay and South Devon NHS Foundation Trust
John Parkes Unit Newton Road
Torquay
TQ2 7BA
United Kingdom

Trial participating centre

Vranch House Charity
Vranch House School Pinhoe Road
Exeter
EX4 8AD
United Kingdom

Trial participating centre

University Hospitals Plymouth NHS Trust
Plymouth Child Development Centre Scott Business Park Deacon Park Road
Plymouth
PL2 2PQ
United Kingdom

Trial participating centre

Royal Cornwall Hospitals NHS Trust
Dolphin House Treliske
Truro
TR1 3LJ
United Kingdom

Sponsor information

Organisation

Plymouth University

Sponsor details

Drake Circus
Plymouth
PL4 8AA
United Kingdom
+44 (0)1752600600
plymouth.sponsor@plymouth.ac.uk

Sponsor type

University/education

Website

https://www.plymouth.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in Child Health and Development

IPD sharing statement
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.

Intention to publish date

01/05/2023

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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).