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

Trunk Oriented Exercises Versus Whole-body Vibration on Abdominal Thickness and Balance in Children With Duchenne Muscular Dystrophy

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.

Study Overview

• Status: Completed
• Conditions: Muscular Dystrophy, Duchenne Type
• Intervention / Treatment: Other: trunk oriented exercise; Other: whole body vibration

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marwa S saleh; Phone Number: 01008342466; Email: marwa_shafiek2000@yahoo.com
• Study Contact Backup: Name: Marwa S Saleh; Phone Number: 01008342466; Email: marwa_shafiek2000@cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt
    • marwa S saleh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group (A)	Other: trunk 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
Active Comparator: Study group (B)	Other: whole 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	change from base line at 4 weeks.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2023
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): April 15, 2023

Study Registration Dates

• First Submitted: January 8, 2023
• First Submitted That Met QC Criteria: January 8, 2023
• First Posted (Actual): January 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Muscular Disorders, Atrophic; Muscular Dystrophies; Muscular Dystrophy, Duchenne
• Other Study ID Numbers: Treatment of Duchenne syndrome

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No