NCT05688072

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

January 8, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

2 months

First QC Date

January 8, 2023

Last Update Submit

April 17, 2023

Conditions

Muscular Dystrophy, Duchenne Type

Outcome Measures

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.

    change from base line at 4 weeks.

Secondary Outcomes (1)

  • balance assessment

    change from base line at 4 weeks.

Study Arms (2)

study group (A)

ACTIVE COMPARATOR
Other: trunk oriented exercise

Study group (B)

ACTIVE COMPARATOR
Other: whole body vibration

Interventions

trunk oriented exerciseOTHER

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

study group (A)
whole body vibrationOTHER

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.

Study group (B)

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

marwa S saleh

Giza, Egypt

Location

Related Publications (1)

  • Ali MS, Saleh MS. Trunk-oriented Exercises Versus Whole-body Vibration on Abdominal Thickness and Balance in Children with Duchene Muscular Dystrophy. J Musculoskelet Neuronal Interact. 2024 Mar 1;24(1):47-54.

    PMID: 38427368DERIVED

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
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistance professor doctor

Study Record Dates

First Submitted

January 8, 2023

First Posted

January 18, 2023

Study Start

January 15, 2023

Primary Completion

March 15, 2023

Study Completion

April 15, 2023

Last Updated

April 18, 2023

Record last verified: 2023-04

Locations

EG(1)