Hydrotherapy in Duchenne Muscular Dystrophy (DMD)

NCT06445985 | Active Not Recruiting DMC

• 2 other identifiers: 30463321/PR/1748
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial aims to establish if there are meaningful benefits to providing a hydrotherapy service for young people with Duchenne muscular dystrophy (DMD). The main aims are to: 1. to allocate a clinical physiotherapist to a project implementing hydrotherapy in young patients with DMD to establish whether there are meaningful benefits to their daily life. 2. to conduct patient and parent interviews to understand the barriers to completing a hydrotherapy intervention and ensure future research addresses meaningful outcomes for those with DMD.

Conditions

Duchenne Muscular Dystrophy

Outcome Measures

Primary Outcomes (3)

• Body Mass via Bioelectrical impedance (BIA)

  Fat mass, body fat percentage and fat free mass will be measured using BIA (bioelectrical impedance). BIA has been validated in DMD and is accurate enough to measure longitudinal changes in body composition and muscle mass in this population

  24 weeks

• Pain Scale

  A pain map assessment of the topographic distribution of daily pain will also be competed, consistent with our previous work in DMD. Scale of 1-10

  24 weeks

• PedsQL QoL / DMD QoL - Quality of Life

  PedsQL QoL - Quality of Life for both participants, and the DMD-QoL Proxy for parents - Scale of 0-4

  24 weeks

Secondary Outcomes (3)

• Upper Limb Strength

  24 weeks

• Range of Motion

  24 weeks

• Pulmonary function

  24 weeks

Study Arms (2)

Control

NO INTERVENTION

Participants will have a 12 week period where they will continue with their habitual physical activity behaviour. Diet and physical activity will be monitored

Hydrotherapy

ACTIVE COMPARATOR

Participants will complete 12-weeks of hydrotherapy, involving up to 60 mins of hydrotherapy once a week. Diet and physical activity will be monitored.

Other: Hydrotherapy

Interventions

Hydrotherapy OTHER

Physiotherapy led pool session

Hydrotherapy

Eligibility Criteria

• Age: 6 Years - 25 Years
• Gender Eligibility Details: DMD affects those born male.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Established diagnosis of Duchenne Muscular Dystrophy (either by genetics or muscle biopsy)
• Between 6 and 25 years of age
• On stable dose of steroids or not on steroids

You may not qualify if:

• Younger than 6 years, older than 25 years
• Recent change in steroid dose, less than 3 months prior
• Undertaking formal hydrotherapy supervised by physiotherapist on a regular basis (weekly or more frequent)

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead
• Duchenne UK: collaborator

Study Sites (1)

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, PR2 9HT, United Kingdom

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Interventions

Hydrotherapy

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Christian De Goede

  Lancashire Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with DMD, show great variability in age and speed of deterioration. As such it is difficult to find matched controls for a short randomised intervention study. Instead, due to the progressive nature of DMD and the inherent variance within a mixed age and ability population, the participants will act as their own controls. This single-arm, non-crossover design where the participant acts as his own control, although not as robust as randomized control exercise trials, is advocated for longitudinal interventions in populations such as the present one.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: June 6, 2024
• Study Start: November 2, 2022
• Primary Completion: April 1, 2025
• Study Completion: December 12, 2025
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)