Regression of Hamstring Flexibility and Performance in Children With Duchenne Muscular Dystrophy

Investigator investigated that regression of hamstring flexibility and performance in children with Duchenne Muscular Dystrophy.

Study Overview

• Status: Completed
• Conditions: Performance; Duchenne Muscular Dystrophy; Flexibility

Detailed Description

Flexibility of hamstrings was evaluated by Popliteal Angle test. Performance was evaluated 6 Minute Walk Test (6 MWT). Regression of hamstring flexibility and performance was examined regression tests. Correlation was examined between popliteal angle test and parameter of North Star Ambulation Assessment.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Sıhhiye
    • Ankara, Sıhhiye, Turkey
      • Hacettepe University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 14 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

Sixty children will participated this study. Fourty-two children was assessed, and eighteen children will assess in a few months.

Description

Inclusion Criteria:

• To be a Duchenne Muscular Dystrophy diagnosis,
• Being in the ambulatory period and climbing four steps independently,
• to be Level 1 and Level 2 according to Brooke Lower Functional Classification Test
• To be able to cooperate
• No any severe contracture in the lower limbs which may prevent assessments,

Exclusion Criteria:

• Children who fail to meet these criteria study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Popliteal Angle Test	The Popliteal Angle Test was used to assess hamstring flexibility. Child asked to rise lower leg straight. Incomplete angle degree of full extension is popliteal angle.	5 minute

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 Minute Walk Test	6 Minute Walk Test was used to assess performance with children Duchenne MUscular Dystropy.	6 minute
North Star Ambulation Assessment	The North Star Ambulatory Assessment (NSAA) is used to assess mobility for in ambulatory children with DMD for 5 years. NSAA is consist of 17 items from stand to run.	20 minute

Collaborators and Investigators

• Sponsor: Hacettepe University
• Investigators: Principal Investigator: Ayşe Karaduman, Prof., Hacettepe University; Principal Investigator: İpek Gürbüz, Assoc.Prof., Hacettepe University; Principal Investigator: Güllü Aydın, Msc., Hacettepe University; Principal Investigator: Numan Bulut, Msc, Hacettepe University; Study Director: Oznur Yılmaz, Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2018
• Primary Completion (Actual): January 24, 2019
• Study Completion (Actual): January 24, 2019

Study Registration Dates

• First Submitted: July 5, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (Actual): July 18, 2018

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Duchenne Muscular Dystrophy; regression; performance; hamstring flexibility
• 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 16/740-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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