Hydrotherapy for Duchenne Muscular Dystrophy (DMD)
Research type
Research Study
Full title
What is the clinical effectiveness of hydrotherapy in maintaining physical function in people with Duchenne muscular dystrophy?
IRAS ID
151441
Contact name
Peter Baxter
Contact email
Sponsor organisation
Sheffield Childrens Hospital NHS Foundation Trust
Research summary
Duchenne muscular dystrophy (DMD) is a rare disease mainly affecting boys. Over time their muscles become weak, reducing their ability to conduct many day-to-day activities. There is no cure, but steroids and a physical management programme are recommended to slow progression and the development of complications. While physical management programmes are usually done on dry land, they can also be performed in warm water, under supervision by a physiotherapist; this is called 'hydrotherapy'. Hydrotherapy enables affected people to perform exercises which may not be possible on land, due to the support provided by the water. Additionally many enjoy it.
However there is no data showing whether it adds anything to land-based exercises alone in terms of helping with walking and other daily activities. This is therefore a small scale pilot study to help decide if a larger scale trial would be feasible and if so, how to best conduct it. We plan to recruit 40 boys with DMD in the UK within 4 to 6 sites. Equal numbers will be randomly allocated to either receive hydrotherapy and land based physiotherapy (active intervention group) or land based physiotherapy alone (control group). Study participants will be assessed for key outcome measures at 3 time points: consent and screen 1 visit; baseline visit; 26 week visit. We will collect information on outcomes relating to the feasibility of conducting the trial which will include interviews with study participants in both groups. We will also collect information about the health of boys - how mobile they are, how independent and active they are and what their quality of life is like. Data relating to the cost of the hydrotherapy to the NHS and to carers will also be gathered.
The project is funded by the HTA (Health Technology Assessment) Programme.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
14/EE/0204
Date of REC Opinion
4 Jul 2014
REC opinion
Further Information Favourable Opinion