NCT07338812

Brief Summary

we measure balance and quadriceps strength in Duchenne muscular dystrophy children after applying virtual reality and whole body vibration

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1 month

First QC Date

January 4, 2026

Last Update Submit

January 4, 2026

Conditions

Keywords

Virtual realitywhole-body vibrationmuscle strengthbalancechildrenDuchenne muscular dystrophy

Outcome Measures

Primary Outcomes (2)

  • balance

    Biodex Balance System (BBS) (BSS; Biodex, Inc, Shirley, NY) was used to evaluate each child's dynamic balance. It is a multiaxial tool that records and evaluates a person's capacity to maintain joint stability under dynamic stress. The BBS uses a circular platform that can move concurrently in the anterior-posterior and medial-lateral axes, unlike force plate technologies.

    12 weeks

  • quadriceps muscle strength

    The Lafayette Manual Muscle Tester (MMT) Model Number 01163 combines accuracy and precision with contemporary ergonomic design to generate exact, impartial, and reliable results. The three replaceable, cushioned stirrups made it possible to employ established methods with assurance and effectiveness while preserving patient comfort

    12 weeks

Study Arms (2)

virtual reality

EXPERIMENTAL

group (A) had designed physical therapy in addition to virtual reality

Device: virtual reality

whole-body vibration

EXPERIMENTAL

group (B) had the same physical therapy program with whole-body vibration

Device: whole body vibration

Interventions

Group (B) had the same physical therapy program with WBV (Power Plate Pro 5) for a total of 10 minutes per session. The apparatus was set at 30 Hz frequency, 2 mm amplitude, and 5 minutes of operating time. The children were squatted down completely on a vibrating, side-alternating platform and were told to stay that way throughout the experience, communicating any pain they felt to the researchers. The vibration feature automatically shuts off after 5 minutes. After that, the children took a one-minute break. Then, with the same settings as those used in the squatting position, children stood on the vibration platform for 5 minutes. In each session, WBV was used for a total of 10 minutes three times per week for three consecutive months.

whole-body vibration

Group (A) had designed physical therapy in form of Warm up with gentle stretching movements to prevent injuries. The lower limb muscles on both sides were stretched for 20 seconds, followed by 20 seconds of relaxation, five times. The quadriceps, hamstrings, anterior tibial group, calf muscles, biceps, and triceps were also contracted isometrically. Every muscle contraction was held for 5 seconds, followed by 5 seconds of relaxation, and the process was repeated five times in addition to virtual reality inform of VR program. Nintendo Wii Fit Balance Board (Nintendo, Kyoto, Japan) was used to perform the exercises. In each session, VR was used for a total of 10 minutes three times per week for three consecutive months.

virtual reality

Eligibility Criteria

Age6 Years - 10 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmuscular dystrophy predominantly affecting boys
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children diagnosed with DMD
  • aged between 6 and 10 years
  • having lower extremities and trunk muscle strength of grade 3+
  • were able to move their upper and lower limbs normally and being able to walk unhindered at levels I and II of the Ambulation function classification system for DMD (AFCSD)

You may not qualify if:

  • cardiopulmonary dysfunction or skeletal abnormalities that are either congenital or acquired
  • had previously experienced lower limb surgical procedure
  • had neurological conditions that affected their balance and gait or had poor motor development
  • exhibited behavioural disorders preventing them from cooperating during the trial
  • being overweight (body mass index (BMI) \>25 kg/ m2) because a lot of fat makes it hard for the ultrasound to measure thickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cairo university

Cairo, 11432, Egypt

Location

Cairo university

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, X-LinkedGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

January 4, 2026

First Posted

January 14, 2026

Study Start

April 11, 2025

Primary Completion

May 20, 2025

Study Completion

October 12, 2025

Last Updated

January 14, 2026

Record last verified: 2026-01

Locations