The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Kinesiology tape

About this trial

This is an interventional supportive care trial for Balance focused on measuring kinesiology taping, balance, Duchenne Muscular Dystrophy

Eligibility Criteria

5 Years - 14 Years (Child)MaleDoes not accept healthy volunteers

Inclusion Criteria:

DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle

Exclusion Criteria:

children who did not meet the above criteria were not included

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kinesiology taping

Arm Description

For tibialis anterior muscle taping, each children's feet were placed at plantar flexion and eversion position while knees were extended, and I-shaped band was applied over tibialis anterior from origin to insertion of muscle with approximately 25-50% tension of the original length of the band. No tension was applied to the first and last 5 cm section of the bands in both applications because it were used as anchor. The tapes were remained for 1 hour on skin of both quadriceps and tibialis anterior muscles, and in this time the children were rested.

Outcomes

Primary Outcome Measures

Balance Test-Timed up and go test

Timed up and go test is a valid and practical objective measure for the pediatric population that measuring various components such as walking speed, postural control, functional mobility and balance. The children were asked to stand up from a chair, walk during 3 meters, turn, and walk back to chair and sit down. This time was recorded as second

Secondary Outcome Measures

Pediatric Berg Balance Test

Pediatric Berg Balance Test is a modified version of the Berg Balance Scale that a valid and reliable test for the elderly population, for children in school age with mild to moderate motor impairment. The patients were asked to maintain their balance at the positions indicated in the test. The score of each item varies according to the parameters of the test. The score of this test is between 0-4 and the highest total score is 56.

duration in standing on one leg

Duration in standing on right and left leg was recorded as second

Full Information

NCT ID

NCT03541070

First Posted

May 15, 2018

Last Updated

May 29, 2018

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT03541070

Brief Title

The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy

Official Title

The Effect of Kinesiology Taping on Balance in Duchenne Muscular Dystrophy

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

June 10, 2017 (Actual)

Primary Completion Date

September 15, 2017 (Actual)

Study Completion Date

November 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

Brief Summary

Investigators investigated that the effects of kinesilogy taping on balance in patients with Duchenne Muscular Dystrophy

Detailed Description

Forty-five patients from Level 1 and 2 according to the Brooke Lower Extremity Functional Classification were included in the study. Balance was assessed by Pediatric Berg Balance Test (PBBT), Timed and Go Test (TUGT), and standing on one leg test. Kinesiology taping (KT) with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles and the assessments were repeated 1 hour after application. The comparison between before and after taping was analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Balance, Duchenne Muscular Dystrophy

Keywords

kinesiology taping, balance, Duchenne Muscular Dystrophy

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Kinesiology taping

Arm Type

Experimental

Arm Description

For tibialis anterior muscle taping, each children's feet were placed at plantar flexion and eversion position while knees were extended, and I-shaped band was applied over tibialis anterior from origin to insertion of muscle with approximately 25-50% tension of the original length of the band. No tension was applied to the first and last 5 cm section of the bands in both applications because it were used as anchor. The tapes were remained for 1 hour on skin of both quadriceps and tibialis anterior muscles, and in this time the children were rested.

Intervention Type

Device

Intervention Name(s)

Kinesiology tape

Intervention Description

Kinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method

Primary Outcome Measure Information:

Title

Balance Test-Timed up and go test

Description

Timed up and go test is a valid and practical objective measure for the pediatric population that measuring various components such as walking speed, postural control, functional mobility and balance. The children were asked to stand up from a chair, walk during 3 meters, turn, and walk back to chair and sit down. This time was recorded as second

Time Frame

About 15 seconds

Secondary Outcome Measure Information:

Title

Pediatric Berg Balance Test

Description

Pediatric Berg Balance Test is a modified version of the Berg Balance Scale that a valid and reliable test for the elderly population, for children in school age with mild to moderate motor impairment. The patients were asked to maintain their balance at the positions indicated in the test. The score of each item varies according to the parameters of the test. The score of this test is between 0-4 and the highest total score is 56.

Time Frame

15 minutes

Title

duration in standing on one leg

Description

Duration in standing on right and left leg was recorded as second

Time Frame

about 1 minute

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria: DMD diagnosis being Level I and II according to Brooke Lower Extremity Functional Classification no cooperation problem no injury or orthopedic/neurologic surgery within the past 6 months no severe contracture at ankle Exclusion Criteria: children who did not meet the above criteria were not included

Overall Study Officials: