CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Low-level mechanical vibrations WITH vertical sinusoidal acceleration +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05281120
NCT05281120N/ACompleted

Low-level Mechanical Vibration, Bone Density, Bone Resorption and Muscular Strength in Ambulant Children Affected by Duchenne Muscular Dystrophy

Istituto Auxologico Italiano·interventional·Posted Mar 16, 2022·Updated Mar 16, 2022

In Brief

A clinical study evaluating Low-level mechanical vibrations WITH vertical sinusoidal acceleration and Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration for Osteoporosis and Duchenne Muscular Dystrophy. Completed, enrolled 20 participants.

Detailed Summary

Duchenne muscular dystrophy (DMD) is a X-linked recessive disorder due to a mutation of the dystrophin gene (Xp21). Dystrophin is a sarcolemmal protein of skeletal and cardiac muscle, and its absence causes progressive muscle degeneration and substitution with fat and connective tissue. The progressive muscle degeneration leads to loss of autonomous walking before the age of 15 years and death for cardiac and/or respiratory failure. There are no specific treatment for DMD, and the standard of care is now based on long-term corticosteroid (CS) use. The studies on bone mass in DMD are very few, but they agree in reporting the presence of a reduced bone mass and an increased rate of fractures probably due to long-term steroid therapy and disuse-osteopenia. The aim of this study, involving 20 ambulant DMD boys (age 7-10 years) has been the evaluation of the effects of low-level mechanical vibrations on bone in a group of ambulant DMD children for 1 year, with RDA-adjusted dietary calcium intake and 25OH vitamin D supplementation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 16, 2022
Enrollment StartNov 1, 2006
Primary CompletionMay 1, 2007
Study CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 4.3 years ago

Interventions

Low-level mechanical vibrations WITH vertical sinusoidal accelerationdevice

Small platform designed to induce vertical, sinusoidal acceleration.

Low-level mechanical vibrations WITHOUT vertical sinusoidal accelerationdevice

Small platform designed to NOT induce vertical, sinusoidal acceleration