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21/23 Strengthening programme for ambulant adolescents with cerebral palsy commissioning brief

 

Contents

Introduction

The aim of the Health Technology Assessment (HTA) Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the clinical effectiveness of a strengthening programme for ambulant adolescents with cerebral palsy?

  • Intervention: Adolescent-specific strengthening or progressive resistance therapy programme (applicants to define and justify).
  • Patient group: Ambulant adolescents with spastic cerebral palsy (applicants to define and justify their eligibility criteria, including age).
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  • Setting: Clinical/community setting.
  • Comparator: Usual practice fitness or physical activity programme without specific strengthening exercises (applicants to define and justify).
  • Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  • Important outcomes: Activities of daily living (including participation in recreation); gross motor function; gait; measurements of strength.
  • Other outcomes: Patient and carer acceptability; treatment fidelity; adherence; independence; balance; educational outcomes; quality of life; adverse effects.
    Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise. 
  • Minimum duration of follow-up: Six months.
  • Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Cerebral palsy (CP) is a lifelong condition affecting movement and co-ordination. It is caused by a problem with the brain that occurs before, during, or shortly after birth, such as a reduction in oxygen supply. It is estimated to affect one in every 400 children in the UK. The underlying brain damage which causes CP will not change over time, but the effects it has on the individual will. Gross motor skills (GMS) such as sitting and walking can improve in early to mid-childhood, levelling off in adolescence and may begin to decline in young adulthood. GMS directly impact on a child and young person’s ability to participate in many aspects of daily living and therefore it is important to maintain GMS for as long as possible.

Physiotherapy is one of the most important treatments for children and adolescents with CP and involves exercises to maintain and hopefully improve movement. Strength or progressive resistance therapy for legs may include, for example, leg press and sit-to-stand exercises. Whilst strengthening exercises are currently widely used, there is a lack of standardisation of both the specific programmes and usual care. As adolescence is a time when young people with CP are likely to lose function, it is important that young people with CP are participating in exercise which is most beneficial to them in terms of maintaining the function they already have.

As such, the British Academy of Childhood Disability Strategic Research Group in conjunction with the Castang Foundation identified this as one of the top research priorities to address the number one uncertainty identified by the James Lind Alliance Childhood Disability Research Priority Setting Partnership. Applications should be co-produced, demonstrating an equal partnership with service commissioners, providers and service users (including carers) in order to provide evidence and actionable findings of immediate utility to decision-makers, should be embedded throughout the life cycle of the project from application to completion. Applicants may wish to consult the NIHR guidance on co-producing research.

A separate call is available for a stretching programme for ambulant children with cerebral palsy: applicants should consider whether synergies between the two calls offer opportunities for efficiency, and we would welcome applicants to propose shared infrastructure between the two calls.

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 28 July 2021. Applications will be considered by the HTA Funding Committee at its meeting in September 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in January 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us at htacommissioning@nihr.ac.uk.