- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07780435
Whole-body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Duchene Muscular Dystrophy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Duchenne Muscular Dystrophy (DMD) is a progressive X-linked neuromuscular disorder characterized by muscle fiber degeneration due to mutations in the dystrophin gene (Birnkrant et al., 2018). As muscle weakness advances, children with DMD experience impaired postural control, reduced balance function, and increased risk of falls, all of which significantly contribute to limitations in daily activities and loss of independence (Ricotti et al., 2016). Early therapeutic interventions are essential to slow functional decline and promote motor stability for as long as possible.
Whole-body vibration (WBV) has emerged as a potential modality to enhance neuromuscular activation, proprioception, and balance in individuals with muscle weakness or neurological impairments. Studies suggest that low-frequency WBV can improve muscle spindle sensitivity, postural reactions, and balance performance in pediatric and neuromuscular populations (Brunetti et al., 2015; Saquetto et al., 2015). Although research involving children with DMD is limited, preliminary evidence indicates that WBV may transiently enhance motor function without excessive muscle strain.
Gravity-force stimulation (GFS)-often delivered through tilt platforms, vertical acceleration devices, or graded gravitational loading-has been proposed as another means to stimulate proprioceptive pathways and increase postural control. GFS can enhance sensory input from weight-bearing structures and may promote improved equilibrium response strategies in children with neuromotor impairments (Bates & Hanson, 2019). However, its application specifically in DMD remains under-studied, and direct comparisons with WBV have not been adequately explored.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Giza Governorate
-
Giza, Giza Governorate, Egypt, 11432
- Cairo University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children diagnosed with Duchenne Muscular Dystrophy (DMD).
- Age between 6 and 10 years.
- Lower extremity and trunk muscle strength graded at least 3+, based on the manual muscle testing criteria.
- Ability to move the upper and lower limbs within functional limits without severe joint restriction.
- Ability to walk independently without assistive devices, corresponding to Levels I and II of the Ambulation Function Classification System for DMD (AFCSD).
Exclusion Criteria:
- Presence of cardiopulmonary dysfunction or congenital or acquired skeletal abnormalities that may interfere with participation.
- History of lower-limb surgical procedures.
- Neurological conditions affecting balance or gait, or evidence of poor motor development not attributable to DMD.
- Behavioral disorders that would prevent cooperation during assessment or intervention sessions.
- Overweight status, defined as a body mass index (BMI) greater than 25 kg/m²
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: whole body vibration group
whole body vibration intervention
|
we use vibrating platform •
|
|
Experimental: force gravity stimulation group
force gravity stimulation intervention
|
Thirty children received: • Gravity-Force Stimulation (GFS), which included:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
abdominal muscle thickness
Time Frame: 3 months
|
measure the abdominal muscle thickness
|
3 months
|
|
postural stability
Time Frame: 3 months
|
• BIODEX MEDICAL SYSTEM used for assessment of postural stability and balance
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mostafa S. Ali, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- P.T.REC/012/006366
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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