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Clinical Trials/NCT04287582
NCT04287582
Unknown
Not Applicable

The Evaluation of Muscle Activation in Climbing up Stairs Activity in Children With Duchenne Muscular Dystrophy

Hacettepe University1 site in 1 country30 target enrollmentApril 3, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Duchenne Muscular Dystrophy
Sponsor
Hacettepe University
Enrollment
30
Locations
1
Primary Endpoint
Surface Electromyographic Measurement
Last Updated
6 years ago

Overview

Brief Summary

Children with Duchenne Muscular Dystrophy (DMD) have difficulties towards the end of the ambulatory period, especially in activities that require lower extremity proximal muscle strength such as walking, climbing stairs, standing up without sitting. Stair climbing / descending activity is a complex activity that requires joint stability, correct muscle synergy and timing. When the literature is examined; It has been observed that the performance of stair climb up and down activity in individuals with neuromuscular disease has been evaluated with various clinical applications. In recent studies, there are surface electromyography (EMG) studies evaluating various aspects of stair climbing and descending activity.

Surface EMG; is a technique for neuromuscular evaluations that is frequently used in both research and clinical applications, noninvasive, and can be used in areas such as neurophysiology, sports science and rehabilitation.

Our study was planned to examine the muscle activations in the lower limb muscles involved in climbing up stairs activity in children with DMD and to compare healthy children with children with DMD and children with different levels of DMD.

Hypothesis originating from the investigation:

H0: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.

H1: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between level 1 and level 2-3 children with early DMD.

H2: There is no difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.

H3: There is a difference in the muscle activations measured by surface electromyography (EMG) of the involved lower extremity muscles during climbing up stairs activity between children with DMD and healthy children.

Detailed Description

In our study, children will be assessed using the surface Electromyography (EMG) device by using electrodes placed in the relevant lower limb muscles that take part during the stair climbing activity. The study included 10 children with DMD levels were 1 and 10 children with DMD levels were 2-3 according to the Brooke Lower Limb Functional Classification scale and 10 healthy children. Muscle activation of vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles will be measured by superficial electromyographic measurement. Muscle activation according to SENIAM (surface EMG for a non-invasive assessment of muscles) for will be evaluated. Stair climbing activity will be performed 3 times and at 1 minute intervals.

Registry
clinicaltrials.gov
Start Date
April 3, 2019
End Date
April 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Bora

Principal Investigator

Hacettepe University

Eligibility Criteria

Inclusion Criteria

  • Children with DMD:
  • Having been diagnosed with Duchenne Muscular Dystrophy by a pediatric neurologist,
  • Volunteering to participate in the study,
  • Being in the 5-12 age range
  • According to the Brooke Lower Limb Functional Classification developed for classifying lower extremity functions of children with DMD, it should be between level 1-3 (children who continue ambulation and can go up and down with assisted / unassisted stairs),
  • To be able to cooperate with the instructions of the physiotherapist
  • Healthy Group:
  • Not having a known acute or chronic illness
  • The children with DMD included in the study have similar demographic characteristics (age, height, weight, body mass index),
  • The physiotherapist should cooperate with the instructions.

Exclusion Criteria

  • Children with DMD:
  • Have undergone any lower limb injuries and / or surgery,
  • Started steroid treatment in the last 6 months,
  • Having any systemic disease other than DMD,
  • Not having permission from his family and himself.
  • Healthy Group:
  • Having had any injury and / or surgery ,
  • Children with DMD have relatives,
  • Not having permission from his family and himself

Outcomes

Primary Outcomes

Surface Electromyographic Measurement

Time Frame: 40 minutes

Muscle Activation Measurement It is an 8-channel system for measuring signals come from muscles (Delsys)

Secondary Outcomes

  • Timed Performance Test(20 minutes)
  • Muscle shortness assessment(10 minutes)
  • Six minute walk test(6 minutes)
  • Muscle Strength Measurement(15 minutes)

Study Sites (1)

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