Multicentre, randomised controlled feasibility study to compare a 10-week physiotherapy programme using an interactive exercise training device to improve walking and balance, to usual care of children with cerebral palsy aged 4-18 years: the ACCEPT study protocol

Rachel Rapson; Jonathan Marsden; Jos Latour; Wendy Ingram; Kara Nicola Stevens; Laura Cocking; Bernie Carter

doi:10.1136/bmjopen-2021-058916

Multicentre, randomised controlled feasibility study to compare a 10-week physiotherapy programme using an interactive exercise training device to improve walking and balance, to usual care of children with cerebral palsy aged 4-18 years: the ACCEPT study protocol

BMJ Open. 2022 May 30;12(5):e058916. doi: 10.1136/bmjopen-2021-058916.

Authors

Rachel Rapson^{1

2}, Jonathan Marsden³, Jos Latour⁴, Wendy Ingram⁵, Kara Nicola Stevens⁶, Laura Cocking⁷, Bernie Carter⁸

Affiliations

¹ Physiotherapy, Children and Family Health Devon, Torbay and South Devon National Health Service Foundation Trust, Torquay, UK rachel.rapson@nhs.net.
² Faculty of Health and human Sciences, University of Plymouth, Plymouth, UK.
³ University of Plymouth Faculty of Health and Human Sciences, Plymouth, UK.
⁴ University of Plymouth School of Nursing and Midwifery, Plymouth, UK.
⁵ Peninsula Clinical Trials Unit, Plymouth University Peninsula Schools of Medicine and Dentistry, Plymouth, UK.
⁶ Medical Statistics, University of Plymouth, Plymouth, UK.
⁷ Peninsula Clinical Trials Unit at Plymouth University (PenCTU), University of Plymouth, Plymouth, UK.
⁸ Faculty of Health and Social Care, Edge Hill University, Ormskirk, UK.

Abstract

Introduction: Children with cerebral palsy (CP) frequently undertake physiotherapy programmes to improve walking and balance. They often require adult support to exercise in a functional position. A novel interactive exercise trainer has been devised to enable children to exercise with against resistance in a functional position, but its efficacy has yet to be proved. A novel protocol has been developed to determine whether a randomised controlled trial (RCT) is feasible.

Aim: To establish whether it is feasible to conduct an RCT to assess the effectiveness of a 10-week physiotherapy intervention using an interactive trainer in children with CP.

Methods and analysis: This study is multicentre randomised controlled feasibility trial with an embedded qualitative study. Forty children with CP, Gross Motor Function Classification System (GMFCS) I-III will be recruited from community paediatric physiotherapy caseloads. Participants will be randomised to 10 weeks of training with the interactive training device or to usual physiotherapy care. The mediolateral motion of the centre of mass estimate and Paediatric Balance Scale will be explored as potential primary outcomes measures, tested at baseline, 10 weeks and follow-up at 20 weeks. The views of child participants, their parents and physiotherapists will be gained through e-diaries and qualitative interviews.Feasibility will be determined by examining recruitment and retention rates, completeness of, adherence to the intervention, appropriateness of outcome measures and effectiveness of blinding. Results will be reported in accordance to Consolidated Standards of Reporting Trials (CONSORT) guidelines.

Ethics and dissemination: Physiotherapists, children and parents have informed trial design and information leaflets. Results will be disseminated via publications, conferences and to families. This study has approval from North of Scotland Research Ethics Committee (20/NS/0018).

Trial registration number: ISRCTN80878394.

Keywords: Developmental neurology & neurodisability; Paediatric neurology; REHABILITATION MEDICINE.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Cerebral Palsy*
Child
Exercise
Feasibility Studies
Humans
Multicenter Studies as Topic
Physical Therapy Modalities
Randomized Controlled Trials as Topic
Walking

Associated data

ISRCTN/ISRCTN80878394