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

Primary Purpose

Muscular Dystrophy, Duchenne Type

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
trunk oriented exercise
whole body vibration
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscular Dystrophy, Duchenne Type

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • marwa S saleh

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

study group (A)

Study group (B)

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 8, 2023
Last Updated
April 17, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05688072
Brief Title
Trunk Oriented Exercises Versus Whole-body Vibration for Duchenne Muscular Dystrophy
Official Title
Trunk Oriented Exercises Versus Whole-body Vibration on Abdominal Thickness and Balance in Children With Duchenne Muscular Dystrophy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscular Dystrophy, Duchenne Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group (A)
Arm Type
Active Comparator
Arm Title
Study group (B)
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
trunk oriented exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
whole body vibration
Intervention Description
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.
Primary Outcome Measure Information:
Title
abdominal muscle thickness
Description
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 Outcome Measure Information:
Title
balance assessment
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
marwa S saleh
City
Giza
Country
Egypt

12. IPD Sharing Statement

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

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