- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01954940
Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy
August 28, 2018 updated by: Dr. Leanne Ward, Children's Hospital of Eastern Ontario
THE EFFECT OF WHOLE BODY VIBRATION THERAPY UPON MUSCLE STRENGTH & FUNCTION IN AMBULATORY BOYS WITH DUCHENNE MUSCULAR DYSTROPHY
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Ottawa, Ontario, Canada, K1H 8L1
- Children's Hospital of Eastern Ontario
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 14 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
Diagnosis of Duchenne muscular dystrophy confirmed by at least one of the following:
- Dystrophin immunofluorescence and/or immunoblot showing complete dystrophin deficiency, and clinical presentation consistent with typical DMD
- Positive gene deletion test (missing one or more exons) in the central rod domain (exons 25-60) of dystrophin, where reading frame can be predicted as "out-of-frame", and clinical presentation consistent with typical DMD
- Complete dystrophin gene sequencing showing an alteration (point mutation, duplication, or other mutation resulting in a stop codon mutation) definitively associated with DMD, and clinical presentation consistent with typical DMD
- Age between 5 - 14 yrs old (inclusive)
- Positive Gower sign (indicating ability to rise from the floor & presence of proximal muscle weakness).
- Able to walk 10 meters in <12 seconds
- Able to stand upon WBVT plate (with knees flexed) for entire treatment protocol (i.e. 15-minutes)
- Stable absolute dose of glucocorticoids (i.e. prednisone or deflazacort) for at least 3 months prior
- Stable absolute doses of all medication that may affect muscle function (i.e. coenzyme Q10, green tea extract, creatine, arginine, glutamine, nutritional supplements, etc.) for at least 3 months prior
- Stable absolute dose of all medication that may affect bone metabolism (i.e. vitamin D and calcium supplementation) for at least 3 months prior
Exclusion Criteria:
- Clinical presentation, genetic testing and/or muscle biopsy consistent with Becker muscular dystrophy
- History of recent surgery (within past 6-months)
- History of a recent fracture (long-bone or vertebral) within past 6-months.
- Acute inflammatory processes of lower extremities (e.g. cellulitis, etc) due to risk of pain and/or worsening inflammatory process
- History of venous thrombosis (theoretically risk of inducing thromboembolic event).
- History of kidney or bladder stones
- History of uncontrolled seizures or severe migraines
- History of cardiac arrhythmia
- Intracranial pathology or hardware (e.g. ventriculoperitoneal shunt, cochlear implant).
- Use of any investigational or experimental products within last 6-months and/or concomitant participation in another study
- Inability or refusal to follow the study requirements (e.g. autism, severe cognitive or behaviour problems)
- Inability or refusal to provide informed consent (parent) and/or assent (child)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
8 weeks
|
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)?
|
8 weeks
|
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)?
|
8 weeks
|
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.
|
8 weeks
|
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)
|
8 weeks
|
Bone health
Time Frame: 8 weeks
|
Does WBVT result in any change in bone health indices (as measured by pQCT and routine skeletal imaging)
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
September 13, 2013
First Submitted That Met QC Criteria
October 4, 2013
First Posted (Estimate)
October 7, 2013
Study Record Updates
Last Update Posted (Actual)
August 31, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- # 12/17E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Duchenne Muscular Dystrophy
-
Cairo UniversityCompletedMuscular Dystrophy, Duchenne TypeEgypt
-
Medical University of GdanskRecruitingDuchenne Muscular Dystrophy (DMD)Poland
-
ItalfarmacoCompletedDuchenne Muscular Dystrophy (DMD)Italy
-
Santhera PharmaceuticalsTerminatedDuchenne Muscular Dystrophy (DMD)United States, Spain, Netherlands, Sweden, Germany, France, Belgium, United Kingdom, Italy, Ireland, Switzerland, Austria, Bulgaria, Hungary, Israel
-
Sarepta Therapeutics, Inc.CompletedDuchenne Muscular Dystrophy (DMD)United States
-
Hospital RudolfstiftungOesterreichische MuskelforschungCompletedCarrier of Duchenne Muscular DystrophyAustria
-
General Hospital of Chinese Armed Police ForcesUnknownDuchenne Muscular Dystrophy (DMD)China
-
Chaitanya Hospital, PuneUnknownMuscular Dystrophy | Duchenne Muscular Dystrophy,India
-
University of FloridaU.S. Army Medical Research and Development CommandRecruitingDuchenne Muscular Dystrophy (DMD)United States
-
PTC TherapeuticsCompletedNonsene Mutation Duchenne Muscular DystrophyUnited States
Clinical Trials on Whole Body Vibration Therapy
-
The Hong Kong Polytechnic UniversityCompleted
-
The Hong Kong Polytechnic UniversityUnknown
-
OHSU Knight Cancer InstituteOregon Health and Science UniversityCompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Chemotherapy-Induced Peripheral NeuropathyUnited States
-
University of SevilleAsociación de Enfermos de Parkinson de SevillaNot yet recruiting
-
The Hong Kong Polytechnic UniversityThe University of Hong Kong; Manchester Metropolitan UniversityTerminatedSpinal Muscular Atrophy Type 3Hong Kong
-
The Hong Kong Polytechnic UniversityCompleted
-
Medway NHS Foundation TrustCompletedUrinary Stress IncontinenceUnited Kingdom
-
Georgia State UniversityTerminatedFalls PreventionUnited States
-
Gazi UniversityGulhane Training and Research HospitalRecruitingArthropathy of Knee | Whole-body Vibration | Swelling/ EdemaTurkey
-
University Hospital Inselspital, BerneBern University of Applied SciencesTerminated