Effects of Low-level Mechanical Vibration on Bone Density in Ambulant Children Affected by Duchenne Muscular Dystrophy
NCT ID: NCT05281120
Last Updated: 2022-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2006-11-30
2007-11-30
Brief Summary
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Detailed Description
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The 20 boys were randomly assigned to two groups:
group 1 (mechanical intervention group) = a mechanical device (a small platform designed to induce vertical, sinusoidal acceleration) was installed in the home of each boy of group 1.
group 2 (placebo control group) = a placebo device was installed in the home of each boy of group 2
All boys were instructed to stand on the platform for 10 minutes each day for 12 months.
Compliance was followed and stimulated through weekly telephone contacts with parents and children.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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mechanical intervention group
20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm.
Intervention: to stand on the active platform (inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months.
Low-level mechanical vibrations WITH vertical sinusoidal acceleration
Small platform designed to induce vertical, sinusoidal acceleration.
mechanical placebo group
20 subjects participated to the study (1 year double-blind, randomized, placebo controlled, parallel group study) and 10 subjects were randomized to this arm.
Intervention: to stand on the placebo platform (not inducing vertical, sinusoidal acceleration) for 10 minutes each day for 12 months.
Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
Small platform designed to NOT induce vertical, sinusoidal acceleration
Interventions
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Low-level mechanical vibrations WITH vertical sinusoidal acceleration
Small platform designed to induce vertical, sinusoidal acceleration.
Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
Small platform designed to NOT induce vertical, sinusoidal acceleration
Eligibility Criteria
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Inclusion Criteria
* Ability to stand up and walk (some balance assistance allowed, but full weight-bearing necessary)
* All the children must already be on glucocorticoid therapy for at least 6 months before the start of the study.
Exclusion Criteria
* The inability to regularly use the vibratory platform.
7 Years
10 Years
MALE
No
Sponsors
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Istituto Auxologico Italiano
OTHER
Responsible Party
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Principal Investigators
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Maria Luisa Bianchi
Role: PRINCIPAL_INVESTIGATOR
Istituto Auxologico Italiano
References
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Mendell JR, Moxley RT, Griggs RC, Brooke MH, Fenichel GM, Miller JP, King W, Signore L, Pandya S, Florence J, et al. Randomized, double-blind six-month trial of prednisone in Duchenne's muscular dystrophy. N Engl J Med. 1989 Jun 15;320(24):1592-7. doi: 10.1056/NEJM198906153202405.
Bonifati MD, Ruzza G, Bonometto P, Berardinelli A, Gorni K, Orcesi S, Lanzi G, Angelini C. A multicenter, double-blind, randomized trial of deflazacort versus prednisone in Duchenne muscular dystrophy. Muscle Nerve. 2000 Sep;23(9):1344-7. doi: 10.1002/1097-4598(200009)23:93.0.co;2-f.
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Other Identifiers
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02C701
Identifier Type: -
Identifier Source: org_study_id
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