- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05940792
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients
July 3, 2023 updated by: Beyzanur Dikmen, Uskudar University
Immediate Effect of Non-Elastic Taping on Gait Balance in Stroke Patients: Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Uskudar University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: intervention group
The intervention group received 45 min of conventional physiotherapy after nonelastic taping, which provides eversion support.
|
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.
|
|
Active Comparator: control group
The control group received 45 min of conventional physiotherapy
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The conventional physiotherapy programme included range of motion exercises, balance and gait training and neuromuscular electrical stimulation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dynamic Gait Index (DGI)
Time Frame: 5 months
|
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
|
5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Beyzanur Dikmen Hoşbaş, Uskudar University
- Study Chair: Berna Karamancıoglu, Uskudar University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2022
Primary Completion (Actual)
October 15, 2022
Study Completion (Actual)
December 30, 2022
Study Registration Dates
First Submitted
June 20, 2023
First Submitted That Met QC Criteria
July 3, 2023
First Posted (Actual)
July 11, 2023
Study Record Updates
Last Update Posted (Actual)
July 11, 2023
Last Update Submitted That Met QC Criteria
July 3, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarU1
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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