The Evaluation of Muscle Activation in Climbing up Stairs Activity in Children With Duchenne Muscular Dystrophy
1 other identifier
observational
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2019
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
April 3, 2019
CompletedFirst Submitted
Initial submission to the registry
February 23, 2020
CompletedFirst Posted
Study publicly available on registry
February 27, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFebruary 27, 2020
February 1, 2020
11 months
February 23, 2020
February 25, 2020
Conditions
Keywords
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
Level 2-3 DMD
According to Brooke Lower Extremity Functional Classification Level 2 or 3
Healthy Group
healthy children with similar demographic characteristics with children with DMD
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.
Eligibility Criteria
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)
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: 15209455BACKGROUNDBakker 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: 12447089BACKGROUNDRainoldi 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: 15102501BACKGROUNDRopars 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: 27622734BACKGROUNDHermens 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: 11018445BACKGROUNDBora 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.
PMID: 34608577DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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