AzTrials
AzTrials

Duchenne Muscular DystrophyNCT01954940

Whole Body Vibration Therapy in Boys With Duchenne Muscular Dystrophy

A study testing Whole Body Vibration Therapy in people with Duchenne Muscular Dystrophy, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 8 to 14 years, men only
Conditions the study is for
Duchenne Muscular Dystrophy
What is being tested?
Whole Body Vibration Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteCanada
Study dates
Mar 2013to Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 14 years
  • Men only
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Being tested
Whole Body Vibration Therapy
Keywords
Whole body vibration therapy, muscle strength testing, bone health, ambulatory, endurance.
Medical subject headings
Muscular Dystrophy, Duchenne

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Whole Body Vibration TherapyDevice

Study groups in NCT01954940
Study groupRoleWhat they receive
Whole Body Vibration TherapyExperimentalGroup will receive daily whole body vibration therapy for up to 9 minutes maximum at a maximum of 18 Hz.
Receives: Device: Whole Body Vibration Therapy
Control groupNo interventionGroup will not receive whole body vibration therapy. This group will conduct all other tests and outcomes except whole body vibration therapy.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Is WBVT safe, convenient and well-tolerated when administered daily to ambulatory to boys with DMD?

    Measured: 8 weeks

Secondary outcomes (6)

  1. Does WBVT result in any change in muscle strength.

    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)

    Measured: 8 weeks

  2. Does WBVT result in any muscle function change.

    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)?

    Measured: 8 weeks

  3. Does WBVT result in any measurable change in muscle endurance.

    Does WBVT result in any measurable change in muscle endurance (total number of steps taken each day, measured by pedometer)?

    Measured: 8 weeks

  4. Quality of life changes.

    Does WBVT result in any change in patient and family reported quality of life report? Measured by the Peds Q of L questionnaire.

    Measured: 8 weeks

  5. Gait changes.

    Does WBVT result in any change in patient's gait (as measured by Gangway gait analysis and Leonardo force plate analysis)

    Measured: 8 weeks

  6. Bone health

    Does WBVT result in any change in bone health indices (as measured by pQCT and routine skeletal imaging)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2013 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2017
  4. Study completionMar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01954940
Sponsor's protocol ID
# 12/17E
Status last verified
Aug 2018
First submitted
13 Sep 2013
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Whole Body Vibration Therapy in people with Duchenne Muscular Dystrophy, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01954940.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in