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CompletedNCT05688072Updated Apr 18, 2023

Trunk Oriented Exercises Versus Whole-body Vibration for Duchenne Muscular Dystrophy

An interventional study of trunk oriented exercise and whole body vibration in Muscular Dystrophy, Duchenne Type, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 6 Years to 10 Years. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
6 Years to 10 Years
Sex
All
01

Study summary

The abdominal muscles play an important role in stabilizing the trunk and providing postural stability. Children with Duchene muscular dystrophy have weak muscles, which may impair postural adjustments. These postural adjustments are required for gait and dynamic balance during the daily living activities.

02

Conditions studied

  • Muscular Dystrophy, Duchenne Type
03

In context

Muscular Dystrophies

548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.

This study's enrollment of 30 is above the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.

Browse Muscular Dystrophies studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosed as Duchenne muscular dystrophy,
  • aged from 6 to 10 years,
  • having grade 3+ muscle strength in lower limbs and trunk muscles.
  • had functional range of motion for upper and lower limb joints,
  • able to walk alone level I and II of Ambulation function classification system for DMD (AFCSD)

Exclusion criteria

  • congenital or acquired skeletal deformities or cardiopulmonary dysfunction,
  • had undergone previous orthopedic surgery in lower limbs,
  • had abnormal motor development or neurological disease that affect balance
  • and gait, and
  • behavioral problems causing inability to cooperate during the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    study group (A)

    Other: trunk oriented exercise

  • Active comparator
    Study group (B)

    Other: whole body vibration

Interventions

  • Othertrunk oriented exercise

    trunk oriented exercises include: stretching exercises, stabilization exercises (active or active-assisted), arm exercises in fixed trunk position, trunk-oriented exercises (active or active-assisted), trunk mobilization (sitting and lying position), and functional reaching exercises with different ranges of motion in shoulder elevation

  • Otherwhole body vibration

    WBV application technique. The children assume a full squatting position on a vibration platform. The apparatus will set at a frequency of 30 Hz, an amplitude of 2 mm, and a duration of 5 min. The children were instructed to remain in squatting position after the vibration started and to report any discomfort that arose. At the end of 5 min, the vibration turned off automatically. Thereafter, the children rested for 1 min. They were then asked to stand on the vibration platform while supported by the therapist for 5 min, with the same parameters as those used in the squatting position. The total time of application of WBV in each session was 10 min.

06

What researchers measure

Primary outcomes

  1. abdominal muscle thickness

    The thickness of four abdominal muscles will be measured with ultrasonography (device type GE Logiq P6) with a frequency of 7.5 MHz. The probe will be placed 2 or 3 cm from the midline, using the umbilicus as a landmark, then will be moved in a semi-circular motion until the deepest image on the screen, the TA, will be visible. To confirm this position and measure the thickness, a skin marker pen will be used. The probe will be then moved in an oblique manner to detect the thickness of the EO, IO, RA, and TA. A large amount of contact gel will be used, and the probe pressure will be adjusted to obtain optimal values of muscle thickness. After image capture, a vertical line will drawn between the superficial and deep aponeurosis to determine muscle thickness.

    Time frame: change from base line at 4 weeks.

Secondary outcomes

  1. balance assessment

    the Biodex Balance System (BBS) (Biodex medical system, Shirley, New York) will be used for balance assessment. Before the evaluation procedures all children will be given an explanatory session to be aware about the different test steps, also the support rails and biofeedback display screen will be adjusted for each child to ensure comfort and safety during the test procedure, then each child will be trained 1 min for adaptation to the machine. During the test, children will be instructed to stand on the platform in the most comfortable posture, and maintain their visual level by focusing straight ahead on the monitor. The platform will be unlocked and children will be allowed to adjust their foot placement until a comfortable standing position will be achieved while they simultaneously maintained a moving pointer at the center point on the monitor and children will be encouraged to maintain the moving pointer at the center point throughout the test.

    Time frame: change from base line at 4 weeks.

07

Study locations

1 site
  • marwa S saleh
    Giza, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05688072
Lead sponsor
Cairo University
Responsible party
Marwa Shafiek Mustafa Saleh (assistance professor doctor, Cairo University) — Principal investigator
First posted
Jan 18, 2023
Start date
Jan 15, 2023
Primary completion
Mar 15, 2023
Completion
Apr 15, 2023
Last update
Apr 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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