Whole-body vibration in children with Neurofibromatosis Type 1 - V1
Research type
Research Study
Full title
Whole-body vibration training compared to muscle-strengthening exercises alone in improving muscle function in children with Neurofibromatosis Type 1
IRAS ID
258178
Contact name
Zulf Mughal
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 0 days
Research summary
Research Summary:
Children with Neurofibromatosis type 1 (NF1) can have weak muscles. In other similar conditions affecting children’s muscles, standing on a vibration device for a few minutes each day can strengthen muscles and improve their ability to perform day-to-day activities. We are looking into whether this vibrating platform can have a similar effect in children with NF1 also, compared to muscle-strengthening exercises alone.Potentially suitable participants (children aged 6-16 years) will be assessed to confirm muscle weakness and that they do not have any other medical problems that would affect use of the vibration device.
Those that have agreed to take part will be randomised either to receive an education session by a physiotherapist advising strengthening exercises that children with weak muscles should perform that they need to continue daily for 6 months; or to receive a vibration device to take home and use for 18 minutes (plus breaks) 5 days a week for 6 months as well as the education session and daily exercises.
All participants will be invited to attend for a variety of tests, just before starting the trial, 6 months later at the end of the trial to see if there is any benefit from the vibration device, and at 9 months to see if there is any persisting effect even after stopping the vibration regime. These tests will involve jumping, hopping and balancing on a board, getting up from a chair, standing on tip-toes, gripping a machine as hard and as long as possible, being fitted with a device that measures your activity for 7 days, walking as far as possible for 6 minutes, scanning muscles, completing a tiredness questionnaire and general well-being questionnaire, and parents completing a questionnaire of the child’s attention.
The trial will be conducted at Manchester University NHS Foundation Trust and Manchester Metropolitan University.
Summary of Results:
Objectives:
Primary - In children with NF1 and muscle weakness, does 6 months of whole-body vibration therapy improve jumping power, compared to muscle-strengthening exercises alone?
Secondary
- In children with NF1 and muscle weakness, does 6 months of whole-body vibration therapy, compared to muscle-strengthening exercises alone, improve hopping force, grip force, balance, walking distance, muscle mass, activity levels, perceived fatigue, perceived well-being and perceived attention?
- Do muscle-strengthening exercises alone improve the above outcome measures from baseline to end of the study?
- Is the currently accepted whole body vibration treatment regime safe and feasible in children with NF1?
- Are changes in jumping power observed earlier than 3 months into the intervention? (unable to assess due to restrictions during lockdown in Covid-19 pandemic)
- On removal of whole-body vibration therapy, do the changes observed in outcomes (if any) persist? (unable to assess due to restrictions during Covid-19 pandemic)Methodology:
Children with NF1 aged 6-16 years with evidence of muscle weakness [grip force standard deviation score (SDS) <-1.0] were randomised following optimal non-bipartite matching to daily muscle-strengthening exercises for 6 months (EXER group), or these daily exercises plus a WBV therapy programme for 6 months (EXER+WBV group). The primary outcome was jumping power SDS measured using mechanography, with secondary and pre-determined exploratory outcomes including jumping efficiency, jumping height, hopping force, grip force, 6-minute walk test, balance, measures of physical activity intensity, measures of perceived fatigue, quality of life and cognition/attention. These outcome measures were undertaken at baseline and at the end of the 6-month intervention period. Qualitative data regarding safety, feasibility and compliance were also collected.Results:
Forty-four children were recruited into the trial (20 males, 24 females; age range 6.1-16.5 years, mean age 10.6 years), with equal allocation to EXER group and EXER+WBV group. There was no effect noted on the primary outcome of jumping power SDS between the two groups at the end of the trial (absolute effect size=-0.1, 95% confidence interval -0.5 to +0.3, relative effect size=0.02, P=0.53). Similarly, no difference was detected with regards to secondary and exploratory outcomes. No significant changes in muscle function SDS were noted from baseline in either intervention group. The regimes within both groups were reported to be feasible. Mean reported compliance to muscle-strengthening exercises was 57%, mean reported compliance to WBV therapy was 50%, and mean measured compliance to WBV therapy was 23%. Compliance was affected by the Covid-19 pandemic and decreased enthusiasm over time. No adverse events were reported.Conclusion:
Six months of daily muscle-strengthening exercises alone or in combination with a WBV therapy programme is safe. No difference in muscle function, balance, physical activity, fatigue or quality of life was detected when WBV therapy was added to daily muscle-strengthening exercises.REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
19/NW/0249
Date of REC Opinion
2 Jul 2019
REC opinion
Further Information Favourable Opinion