Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption

Back to results

Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Kinesiology Taping

About this trial

This is an interventional supportive care trial for Performance focused on measuring kinesiology taping, performance, energy consumption, gait, Duchenne Muscular Dystrophy

Eligibility Criteria

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

Inclusion Criteria:

Duchenne Muscular Dystrophy diagnosis,
age 5 to 14 years,
able to cooperate with instructions of physiotherapist,
able to walk independently,
climb 4 steps independently/with minimal support from handrails.

Exclusion Criteria:

severe contracture at lower extremities,
other disease except for DMD, and
history of any injury or orthopaedic/neurologic surgery within the past 6 months.

Sites / Locations

Hacettepe University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Kinesiology taping

Arm Description

After performing the baseline assessments, kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles of children. In both applications, the first and last 5 cm section of the bands were used as anchor and no tension was applied.

Outcomes

Primary Outcome Measures

Six Minute Walk Test

Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.

Secondary Outcome Measures

Energy Consumption

Physiologic Consumption Index (PCI) was used to evaluate energy consumption of children during 6MWT. energy consumption was calculated by using the formula of PCI (walking heart rate)-(resting heart rate)/(walking speed)

Gait

Gait analysis of the children was performed by footprint method on 10-meters powdered floor. First and last 2 meters of this floor were dissociated from the assessment, and both the right and left stride lengths, both right and left foot angles, and stride width were analyzed in the middle 6-meter section.. Stride length was measured by measuring the distance between right and left midpoint heels. Double stride length was sum of right and left stride length. Stride width was measured by horizontal distance between heel midpoints. Foot angles were measured by a goniometer considering the line between the first and second metatarsal heads and the heel midpoints of both feet separately 24. The number of steps during 6MWT was also calculated by pedometer (Omron, Walking style One 2.0 HJ-320-E) and recorded.

Timed Performance Test

Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.

Full Information

NCT ID

NCT03529240

First Posted

May 6, 2018

Last Updated

May 17, 2018

Sponsor

Hacettepe University

1. Study Identification

Unique Protocol Identification Number

NCT03529240

Brief Title

Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption

Official Title

Kinesiology Taping in Duchenne Muscular Dystrophy: Effects on Performance, Gait Characteristics, and Energy Consumption

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

August 5, 2017 (Actual)

Study Completion Date

October 5, 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 performance, energy consumption and gait characteristics 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. Performance was assessed by measuring the distance in 6-minute walk test (6MWT) and the duration of timed performance tests; energy consumption by Physiological Consumption Index (PCI), and gait characteristics by footprint method on powdered ground at baseline. Kinesiology taping 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

Performance, Energy, Gait, Duchenne Muscular Dystrophy

Keywords

kinesiology taping, performance, energy consumption, gait, 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

After performing the baseline assessments, kinesiology taping with facilitation technique was applied on bilateral quadriceps and tibialis anterior muscles of children. In both applications, the first and last 5 cm section of the bands were used as anchor and no tension was applied.

Intervention Type

Device

Intervention Name(s)

Kinesiology Taping

Intervention Description

Kinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping. KT is applied by specialized physiotherapists and physicians. This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries. Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation

Primary Outcome Measure Information:

Title

Six Minute Walk Test

Description

Six Minute Walk Test was used commonly in DMD were found to be valid, reliable and easy to apply in the clinic. Children were asked to walk during 6 minutes as fast as they can at a corridor specified by two cones and walking distances were recorded as meter (m) for 6MWT. The time passed during timed performance tests were recorded as seconds.

Time Frame

6 minute

Secondary Outcome Measure Information:

Title

Energy Consumption

Description

Physiologic Consumption Index (PCI) was used to evaluate energy consumption of children during 6MWT. energy consumption was calculated by using the formula of PCI (walking heart rate)-(resting heart rate)/(walking speed)

Time Frame

6 minutes

Title

Gait

Description

Gait analysis of the children was performed by footprint method on 10-meters powdered floor. First and last 2 meters of this floor were dissociated from the assessment, and both the right and left stride lengths, both right and left foot angles, and stride width were analyzed in the middle 6-meter section.. Stride length was measured by measuring the distance between right and left midpoint heels. Double stride length was sum of right and left stride length. Stride width was measured by horizontal distance between heel midpoints. Foot angles were measured by a goniometer considering the line between the first and second metatarsal heads and the heel midpoints of both feet separately 24. The number of steps during 6MWT was also calculated by pedometer (Omron, Walking style One 2.0 HJ-320-E) and recorded.

Time Frame

2 minutes

Title

Timed Performance Test

Description

Ascending-descending standard 4 steps, walking 10m, standing from lying position were used in order to assess the performance of children.The time passed during timed performance tests were recorded as seconds.

Time Frame

10 minutes

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: Duchenne Muscular Dystrophy diagnosis, age 5 to 14 years, able to cooperate with instructions of physiotherapist, able to walk independently, climb 4 steps independently/with minimal support from handrails. Exclusion Criteria: severe contracture at lower extremities, other disease except for DMD, and history of any injury or orthopaedic/neurologic surgery within the past 6 months.

Overall Study Officials: