Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01954940|
Recruitment Status : Completed
First Posted : October 7, 2013
Last Update Posted : August 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Duchenne Muscular Dystrophy||Device: Whole Body Vibration Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||THE EFFECT OF WHOLE BODY VIBRATION THERAPY UPON MUSCLE STRENGTH & FUNCTION IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY|
|Study Start Date :||March 2013|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Experimental: Whole Body Vibration Therapy
Group will receive daily whole body vibration therapy for up to 9 minutes maximum at a maximum of 18 Hz.
Device: Whole Body Vibration Therapy
No Intervention: Control group
Group will not receive whole body vibration therapy. This group will conduct all other tests and outcomes except whole body vibration therapy.
- Assess the safety of using whole body vibration therapy in boys with Duchenne muscular dystrophy. To assess whether whole body vibration therapy can improve muscle strength and prolong ambulation from baseline to 8 weeks of therapy. To asses. [ Time Frame: 8 weeks ]Is WBVT safe, convenient and well-tolerated when administered daily to ambulatory to boys with DMD?
- Does WBVT result in any change in muscle strength. [ 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)
- Does WBVT result in any muscle function change. [ 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)?
- Does WBVT result in any measurable change in muscle endurance. [ Time Frame: 8 weeks ]Does WBVT result in any measurable change in muscle endurance (total number of steps taken each day, measured by pedometer)?
- Quality of life changes. [ 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.
- Gait changes. [ 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)
- Bone health [ Time Frame: 8 weeks ]Does WBVT result in any change in bone health indices (as measured by pQCT and routine skeletal imaging)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954940
|Children's Hospital of Eastern Ontario|
|Ottawa, Ontario, Canada, K1H 8L1|
|Principal Investigator:||Leanne Ward, MD||Children's Hospital of Eastern Ontario|