Standing Frames in Cerebral Palsy
| ISRCTN | ISRCTN82916961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82916961 |
| Protocol serial number | HTA 13/144/01 |
| Sponsor | Newcastle Upon Tyne NHS Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 05/10/2015
- Registration date
- 16/10/2015
- Last edited
- 21/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
One in 400 UK children has cerebral palsy, leading to difficulty with movement, coordination and muscle tightness. Children with severe cerebral palsy may be unable to walk and have associated learning or communication difficulties. Cerebral palsy is caused by damage to the brain while it is rapidly developing, before birth or in the first year of life. Although the brain damage does not worsen, effects on the body such as pain, spasms, limb and joint deformity do. These children need physiotherapy, including management of posture. One aspect of this is the use of a Standing Frame, a rigid frame with a wide base. A child is positioned in the frame with fastenings to enable him/her to be vertical, yet free to use his/her arms and hands. There is much variation in type of frame and how long children are positioned in them. Standing frames have many proposed benefits such as improvement in limb movement, bone strength, bladder and bowel control, breathing and participation in activities as well as the prevention of hip dislocation. There is little evidence to support such benefits. Frames also have disadvantages such as taking up space, being uncomfortable, needing time to position children in them, cost, and therapist time to monitor use. In order to assess the usefulness of standing frames, we would ideally carry out a trial in which children were assigned by chance to having treatment with a frame or not. However, withholding treatment with a frame may not be acceptable to some children, parents and healthcare providers who have firm views that they are helpful. So, before designing a trial, we must find out:
1. Current practice: How are frames used? How long are children being asked to stand in them? What are the difficulties with using frames?
2. Attitudes: What do users think about frames? Why do they think they are useful? Are trials needed? What are the pros and cons of frame use?
3. Thoughts on proposed trial designs: Would users be prepared to change the time spent in a frame each day? Would users be prepared to stop using a frame, or be allocated by chance to different treatments in a research trial?
Here, two surveys will be carried out and discussions held with children, parents and healthcare providers to prepare for a trial or trials of the effectiveness of standing frames to help children with cerebral palsy.
Who can participate?
Parents of young children using standing frames for cerebral palsy, healthcare and educational professionals working with children who use standing frames and children and young people (aged 8-18) that have cerebral palsy and use standing frames.
What does the study involve?
The study involves three steps. The first is a survey asking professionals and parents about how standing frames are currently used. The second step involves discussions using focus groups with parents and healthcare staff and one to one interviews with children using the frames in order to understand attitudes to standing frame use and how acceptable they would consider a trial. The third step involves a second survey to bring together the findings from the first two steps and ask for opinions on potential trial designs. Both surveys are sent via internet or post to parents and health and named education staff, with questions adjusted for each group. This will help in designing future trials to assess the benefits of standing frames.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Newcastle University, Great North Children's Hospital, Robert Jones and Agnes Hunt Hospital (Oswestry) and Chailey Heritage Clinical Services (UK)
When is the study starting and how long is it expected to run for?
October 2015 to July 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Jill Kisler
Contact information
Scientific
Associate: Institute of Neuroscience. Newcastle University
Level 3: Sir James Spence Institute of Child Health
Royal Victoria Infirmary
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Sequential, mixed-methods (quantitative and qualitative) studies |
| Secondary study design | Sequential, mixed-methods (quantitative and qualitative) studies |
| Study type | Participant information sheet |
| Scientific title | Standing Frames as part of Postural Management for Children with spasticity. What is the acceptability of a trial to determine the efficacy of standing frames. |
| Study objectives | The aim is to answer the question: What is the likely acceptability of a future trial to determine the efficacy of standing frames? We plan to undertake two surveys and qualitative research to assess the feasibility and inform the design of a trial (or trials) of standing frame use for children with cerebral palsy (CP). |
| Ethics approval(s) | East Midlands - Nottingham 1 Research Ethics Committee, 07/12/2015, ref: 15/EM/0495 |
| Health condition(s) or problem(s) studied | Cerebral palsy |
| Intervention | Participants will be completing surveys and there will be focus groups of parents and professionals and in-depth interviews with young people. Steps include: 1. Survey 1: Professionals (health and education staff) and parents: to identify current use of standing frames. 2. Qualitative research: focus group work with parents and professionals; in-depth interviews with children to understand attitudes to standing frame use and acceptability of a trial. 3. Synthesis of findings from survey 1 and qualitative research, and development of potential trial designs with appropriate comparators and outcome measures. 4. Survey 2: Professionals and parents: regarding acceptability and feasibility of potential trial designs, including willingness to recruit (professionals), to have their child randomized (parents), comparators and outcome measures. 5. Propose a design for a substantive trial or trials. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Description of current standing frame use for children with CP (including treatment indications, treatment goals, types of frame, durations of intended and actual use; perceptions and practicalities of standing frame use) |
| Key secondary outcome measure(s) |
N/A |
| Completion date | 31/07/2017 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Mixed |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | 1. Parents of young children using standing frames for cerebral palsy 2. Healthcare professionals working with children who use standing frames 3. Education professionals and other carers working with children who use standing frames 4. Children and young people age 8-18 years who have cerebral palsy GMFCS IV or V and use standing frames |
| Key exclusion criteria | Severe cognitive impairment and/or significant communication difficulties resulting in inability to be able to make simple choices or communicate “yes” vs. “no” responses. |
| Date of first enrolment | 01/01/2016 |
| Date of final enrolment | 30/04/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
United Kingdom
Newcastle
NE1 4LP
United Kingdom
Shropshire
SY10 7AG
United Kingdom
Lewes
East Sussex
BN8 4JN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/12/2020: Internal review.
09/02/2017: Internal review.
30/03/2016: Ethics approval information added.
