Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Mrs Chin Maguire


Contact details

Health Services Research
School of Health & related Research (ScHARR) Regents Court
30 Regent Street
S1 4DA
United Kingdom

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

What is the clinical effectiveness of hydrotherapy in maintaining physical function in people with Duchenne muscular dystrophy?


Hydrotherapy for Duchenne Muscular Dystrophy (DMD)

Study hypothesis

Duchenne muscular dystrophy (DMD) is a rare disease mainly affecting boys. DMD causes muscle cells to gradually break down so that with time, a patient’s muscles become weak to the point where they are unable to conduct many of the activities they used to. There is no cure for this disease, but doctors and physiotherapists try to slow down its progression and the development of complications by prescribing steroids and a physical management programme. Clinical experience shows that physical activity helps to maintain functional abilities. Mostly physical management programmes are done on dry land. However they can also be performed in warm water, under supervision by a physiotherapist; this is known as 'hydrotherapy' or 'aquatic therapy'. Hydrotherapy enables affected people to perform exercises which may not be possible on land due to the support provided by the water. Additionally the activity is seen as fun for them and their carers. Despite this, hydrotherapy is difficult to access in many places in the UK. Many NHS trusts do not fund it or have not got the facilities to offer it. While we know people with DMD value hydrotherapy, we are not sure whether it really adds anything to land-based exercises alone in terms of helping with walking and other daily activities. We are therefore undertaking a small scale pilot study to help decide if a larger scale trial would be feasible and if so, how we should best conduct it.

Ethics approval


Study design

Randomised; Interventional; Design type: Treatment

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Topic: Children, Genetics; Subtopic: All Diagnoses, Genetics Research and Congenital Disorders (all subtopics); Disease: Genetics Research and Congenital Disorders, All Diseases


Participants will be allocated on a ratio of 1:1 using simple randomisation with permuted blinded block size to:
1. Control group to receive optimised land-based exercises (as defined by local community physiotherapy services and recorded by trial team) (n=20)
2. The intervention group will receive the same plus hydrotherapy (30 min, twice weekly, for 6 months: active assisted and/or passive stretching regime; simulated or real functional activities; sub-maximal exercise) (n=20)

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 a number of outcomes relating to the feasibility of conducting the trial which will include interviews with participants.

Intervention type



Not Applicable

Drug names

Primary outcome measure

The feasibility of recruitment to the main trial

Secondary outcome measures

Not provided at time of registration

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Genetically or biopsy confirmed DMD
2. Age 7-16 years
3. Established on glucocorticosteroids
4. North Star Ambulatory Assessment score 8-34 (stable over 4 weeks)
5. Able to complete 10 metre walk (6 minute walk test)

Participant type


Age group




Target number of participants

Planned Sample Size: 40; UK Sample Size: 40

Participant exclusion criteria

1.More than a 20% variation between baseline North Star Ambulatory Assessment scores
2.Unable to commit to the programme of twice weekly hydrotherapy for 6 months
3.Any absolute contraindications or precautions to hydrotherapy

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research, School of Health & related Research (ScHARR) Regents Court
S1 4DA
United Kingdom

Sponsor information


Sheffield Children's Hospital (UK)

Sponsor details

Western Bank
S10 2TH
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

NIHR Evaluation, Trials and Studies Coordinating Centre (NETSCC) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

31/03/2017: Publication reference added.