NCT04287582

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 7, 2020

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

February 23, 2020

Last Update Submit

February 25, 2020

Conditions

Keywords

duchenne muscular dystrophysurface electromyographymuscle activationstair climbing

Outcome Measures

Primary Outcomes (1)

  • Surface Electromyographic Measurement

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

    40 minutes

Secondary Outcomes (4)

  • Muscle Strength Measurement

    15 minutes

  • Timed Performance Test

    20 minutes

  • Muscle shortness assessment

    10 minutes

  • Six minute walk test

    6 minutes

Study Arms (3)

Level 1 DMD

According to Brooke Lower Extremity Functional Classification Level 1

Other: Electromyographic device

Level 2-3 DMD

According to Brooke Lower Extremity Functional Classification Level 2 or 3

Other: Electromyographic device

Healthy Group

healthy children with similar demographic characteristics with children with DMD

Other: Electromyographic device

Interventions

An 8-channel surface EMG system (DELSYS Trigno Wireless System) will be used to measure signals from muscles during stair climbing activity by surface electromyography measurements.Surface EMG measurements will be carried out during stair climbing activity without any intervention in the body. Surface EMG electrodes will be placed bilaterally in the vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles.

Healthy GroupLevel 1 DMDLevel 2-3 DMD

Eligibility Criteria

Age5 Years - 12 Years
Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study included 20 children with DMD applied in the Hacettepe University Pediatric Neuromuscular Disorders Unit and 10 children aged 5-12 years living in Ankara who do not have any disease.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06680, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • Uchikawa K, Liu M, Hanayama K, Tsuji T, Fujiwara T, Chino N. Functional status and muscle strength in people with Duchenne muscular dystrophy living in the community. J Rehabil Med. 2004 May;36(3):124-9. doi: 10.1080/16501970410023461.

    PMID: 15209455BACKGROUND
  • Bakker JP, De Groot IJ, Beelen A, Lankhorst GJ. Predictive factors of cessation of ambulation in patients with Duchenne muscular dystrophy. Am J Phys Med Rehabil. 2002 Dec;81(12):906-12. doi: 10.1097/00002060-200212000-00004.

    PMID: 12447089BACKGROUND
  • Rainoldi A, Melchiorri G, Caruso I. A method for positioning electrodes during surface EMG recordings in lower limb muscles. J Neurosci Methods. 2004 Mar 15;134(1):37-43. doi: 10.1016/j.jneumeth.2003.10.014.

    PMID: 15102501BACKGROUND
  • Ropars J, Lempereur M, Vuillerot C, Tiffreau V, Peudenier S, Cuisset JM, Pereon Y, Leboeuf F, Delporte L, Delpierre Y, Gross R, Brochard S. Muscle Activation during Gait in Children with Duchenne Muscular Dystrophy. PLoS One. 2016 Sep 13;11(9):e0161938. doi: 10.1371/journal.pone.0161938. eCollection 2016.

    PMID: 27622734BACKGROUND
  • Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.

    PMID: 11018445BACKGROUND
  • Bora M, Yalcin A, Bulut N, Yilmaz O, Karaduman A, Topuz S, Alemdaroglu-Gurbuz I. Investigation of surface electromyography amplitude values during stair climbing task in children with Duchenne muscular dystrophy. Neurol Sci. 2022 Apr;43(4):2791-2801. doi: 10.1007/s10072-021-05643-y. Epub 2021 Oct 4.

Related Links

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

Central Study Contacts

Merve B Bora, PT

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 27, 2020

Study Start

April 3, 2019

Primary Completion

March 7, 2020

Study Completion

April 1, 2020

Last Updated

February 27, 2020

Record last verified: 2020-02

Locations