Trials / Completed
CompletedNCT01954940
Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy
THE EFFECT OF WHOLE BODY VIBRATION THERAPY UPON MUSCLE STRENGTH & FUNCTION IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 4 (actual)
- Sponsor
- Children's Hospital of Eastern Ontario · Academic / Other
- Sex
- Male
- Age
- 8 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
Whole-body vibration therapy (WBVT) is a novel, non-pharmacological intervention aimed at improving muscle strength and endurance as well as bone density. It holds promise for children with neuromuscular disorders such as Duchenne muscular dystrophy (DMD) since muscle weakness results not only from muscle breakdown but also physical inactivity and muscle disuse atrophy. Weak DMD patients may increasingly limit their physical activity due to fear of falling or loss of independence (e.g. difficulty rising to stand without assistance). Prolonging the length of time boys with DMD are ambulatory is important for delaying complications of this disease (lung hypoventilation, scoliosis) as well as maintaining bone health. We propose to conduct a pilot study of WBVT in young boys with Duchenne muscular dystrophy (DMD). The primary outcome will be to document safety and feasibility of WBVT in this patient population. The secondary outcomes will evaluate changes in muscle strength and endurance. Bone health will also be examined as part of routine clinical care. The study will include 20 ambulatory boys with DMD; patients will be randomized (1:1 allocation) into 2 groups: WBVT treatment or no WBVT treatment (controls). Treatment groups will consist of 10 boys undergoing daily WBVT in an 8-week, open-label trial.
Detailed description
Post-Study Completion Note: Given competition for enrollment in other DMD trials and burden from daily home WBVT training, it was not feasible to study WBVT in the trial setting, nor is it likely to be a feasible modality for optimizing musculoskeletal health in routine care.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Whole Body Vibration Therapy |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2017-03-01
- Completion
- 2017-03-01
- First posted
- 2013-10-07
- Last updated
- 2018-08-31
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT01954940. Inclusion in this directory is not an endorsement.