Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
NCT Number: NCT01954940
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.
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Notify Me8 year–14 year
Male
Interventional
Not applicable
Ottawa, Ontario, K1H 8L1, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 8 weeks
Is WBVT safe, convenient and well-tolerated when administered daily to ambulatory to boys with DMD?
Time frame: 8 weeks
Does WBVT results in any measurable change in muscle strength measured by the maximum resistance of deltoid, hip flexor and knee extensor (measured with microFET2 dynamometer) and grip strength (measured by Jamar hand-held dynamometer)
Time frame: 8 weeks
Does WBVT results in any measurable change in muscle function as measured by timed functional testing (timed 10m walk test; timed 4-stair climb; timed Gower manoeuvre, 6-minute walk test)?
Time frame: 8 weeks
Does WBVT result in any measurable change in muscle endurance (total number of steps taken each day, measured by pedometer)?
Time frame: 8 weeks
Does WBVT result in any change in patient and family reported quality of life report? Measured by the Peds Q of L questionnaire.
Time frame: 8 weeks
Does WBVT result in any change in patient's gait (as measured by Gangway gait analysis and Leonardo force plate analysis)
Time frame: 8 weeks
Does WBVT result in any change in bone health indices (as measured by pQCT and routine skeletal imaging)
Children's Hospital of Eastern Ontario
Other
THE EFFECT OF WHOLE BODY VIBRATION THERAPY UPON MUSCLE STRENGTH & FUNCTION IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY
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