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

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.

Study Overview

• Status: Unknown
• Conditions: Duchenne Muscular Dystrophy
• Intervention / Treatment: Other: Electromyographic device

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.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Merve B Bora, PT; Phone Number: +90 5058625335; Email: mervebora95@gmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06680
    • Recruiting
    • Hacettepe University
    • Contact: Merve Bora, PT; Phone Number: 05058625335; Email: mervebora95@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Level 1 DMD; According to Brooke Lower Extremity Functional Classification Level 1	Other: Electromyographic device; 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.
Level 2-3 DMD; According to Brooke Lower Extremity Functional Classification Level 2 or 3	Other: Electromyographic device; 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 Group; healthy children with similar demographic characteristics with children with DMD	Other: Electromyographic device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surface Electromyographic Measurement	Muscle Activation Measurement It is an 8-channel system for measuring signals come from muscles (Delsys)	40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle Strength Measurement	A quantitative and objective method for assessment of muscular strength using a portable hand held dynamometer. Muscle strength measurement included lower limb and trunk muscles.	15 minutes
Timed Performance Test	Timed function tests included time taken to stand from a supine position, time taken to walk 10 m, time taken to climb 4 standard-sized stairs and time taken to descend 4 standard-sized stairs.	20 minutes
Muscle shortness assessment	Shortening assessment of trunk and lower extremity muscles measurement included back extensors, hamstring, hip flexors, quadriceps and gastrocnemius muscles.	10 minutes
Six minute walk test	Children were asked to walk during 6 minutes as fast as possible at a 25 meter corridor.	6 minutes

Collaborators and Investigators

• Sponsor: Hacettepe University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• SENIAM

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2019
• Primary Completion (Anticipated): March 7, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 23, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 27, 2020
• Last Update Submitted That Met QC Criteria: February 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: muscle activation; surface electromyography; duchenne muscular dystrophy; stair climbing
• 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: GO 19/323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

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