Back to resultsImmediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Nonelastic taping
Conservative physiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring balance, gait, immediate, stroke, taping
Eligibility Criteria
Inclusion Criteria: having a stroke diagnosis at least 6 months ago, being between the ages of 18 and 75, having a spasticity grade of 0, 1, 1+, 2 according to the Modified Ashworth Scale, having no cooperation problems and being mobilized without support. Exclusion Criteria: orthopedic problems such as surgical intervention, fracture history, presence of cognitive, visual, or cardiovascular diseases skin sensitivity in the foot and ankle that may affect gait.
Sites / Locations
- Uskudar University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group
control group
Arm Description
The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support.
The control group received 45 min of conventional physiotherapy
Outcomes
Primary Outcome Measures
Dynamic Gait Index (DGI)
The dynamic gait index includes 8 items: walking, walking at different speeds, crossing an obstacle, walking around an obstacle, suddenly turning 180 degrees while walking and stopping, climbing steps, walking by turning the head left and right in the horizontal plane, and walking by turning the head up and down in the vertical plane. The performance of each item was graded with 4 points. The score scale is as follows; 3 independent walking, 2 mild impairment, 1 moderate impairment and 0 severe impairment; the total score that can be obtained varies between 0-24 points. If the total score is between 22and24, it can be said that individuals have safe ambulation, 20-21 points are considered to be a harbinger of fall risk, and scores of 19 or lower have been associated with an increased incidence of falls
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05940792
Brief Title
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
Official Title
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
October 15, 2022 (Actual)
Study Completion Date
December 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar 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
After a stroke, most patients have poor ankle control and difficulty walking. Considering that proper foot placement will provide a more balanced and controlled gait, the aim of this study was to investigate the immediate effect of non-elastic ankle taping providing eversion support on gait balance in stroke patients.
Detailed Description
The study included 30 stroke patients. Participants were randomly assigned to two groups: intervention group(n=15) and the control group(n=15). The control group received 45 min of conventional physiotherapy. The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support. The gait balance of both groups was evaluated using the Dynamic Gait Index before and after treatment. . Pre- and post-intervention data were statistically analyzed and compared.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
balance, gait, immediate, stroke, taping
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The control group received 45 min of conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Nonelastic taping
Intervention Description
Non-elastic taping was placed on the ankle of the affected side with a plaster band starting from the middle of the sole of the foot and extending from the lateral side of the foot to the level below the knee to provide eversion support.
Intervention Type
Other
Intervention Name(s)
Conservative physiotherapy
Intervention Description
The conventional physiotherapy programme included range of motion exercises, balance and gait training and neuromuscular electrical stimulation.
Primary Outcome Measure Information:
Title
Dynamic Gait Index (DGI)
Description
The dynamic gait index includes 8 items: walking, walking at different speeds, crossing an obstacle, walking around an obstacle, suddenly turning 180 degrees while walking and stopping, climbing steps, walking by turning the head left and right in the horizontal plane, and walking by turning the head up and down in the vertical plane. The performance of each item was graded with 4 points. The score scale is as follows; 3 independent walking, 2 mild impairment, 1 moderate impairment and 0 severe impairment; the total score that can be obtained varies between 0-24 points. If the total score is between 22and24, it can be said that individuals have safe ambulation, 20-21 points are considered to be a harbinger of fall risk, and scores of 19 or lower have been associated with an increased incidence of falls
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
having a stroke diagnosis at least 6 months ago,
being between the ages of 18 and 75,
having a spasticity grade of 0, 1, 1+, 2 according to the Modified Ashworth Scale,
having no cooperation problems and being mobilized without support.
Exclusion Criteria:
orthopedic problems such as surgical intervention, fracture history, presence of cognitive, visual, or cardiovascular diseases
skin sensitivity in the foot and ankle that may affect gait.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beyzanur Dikmen Hoşbaş
Organizational Affiliation
Uskudar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berna Karamancıoglu
Organizational Affiliation
Uskudar University
Official's Role
Study Chair
Facility Information:
Facility Name
Uskudar University
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
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