- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06318624
Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients
November 5, 2024 updated by: Ismail Okur, Kutahya Health Sciences University
Immediate Effects of Ankle Mobilization With Movement and Mulligan Talocrural Taping on Gait and Balance in Stroke Patients
Disorders caused by stroke may lead to significant limitations, especially in ankle range of motion, and may cause impairments in walking and balance functions.
This limitation in ankle range of motion leads to difficulties in weight transfer, stability, and balance.
As a result, there is a decrease in walking performance and an increased risk of falls.
Various interventions have been used to improve ankle dorsiflexion passive range of motion, including gastrosoleus muscle stretching, muscle strengthening training, functional electrical stimulation training, proprioceptive control training, taping, manual therapy, different mobilization techniques, and ankle mobilization with motion (MWM).There are limited studies investigating the immediate effects of MWM and taping on gait and balance in stroke patients.
This study was planned to investigate the effect of Mulligan's ankle MWM technique and talus stabilization taping on spatiotemporal gait and balance parameters in stroke patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
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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Kütahya, Turkey, 43100
- Kütahya Health Sciences 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 unilateral stroke for more than three months,
- Being able to walk 10 meters without an assistive device,
- Being able to walk unassisted before having a stroke,
- Having a score of 3 or lower on the Modified Ashworth Scale (MAS),
- Be able to follow simple verbal instructions,
- Being Volunteer
Exclusion Criteria:
- Having had more than one stroke,
- Cerebellar involvement,
- Having severe visual impairment,
- Having cognitive impairment,
- Severe aphasia,
- Apraxia,
- Having contraindications for joint mobilization (e.g. ankle hypermobility, trauma, inflammation),
- Have significant lower limb problems such as fractures or arthritis,
- Having undergone musculoskeletal surgery less than 6 months ago,
- Having joint contracture in the paretic ankle that prevents walking.
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 |
|---|---|
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Experimental: Intervention Group
Movement with Motion technique of Mulligan Concept to the ankle joint and taping will be performed on the participants in the Intervention Group.
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For MWM for the talocrural joint, the hemiparetic side of the participant is positioned in a standing position on a stool.
A non-elastic belt is passed behind the patient's distal tibia and secured around the therapist's pelvis.
The patient is asked to perform active knee flexion and ankle dorsiflexion with weight on the hemiparetic side.
Meanwhile, the therapist performs forward sliding of the tibia with the help of the belt.
For 10 seconds active and painless sliding takes place and then return to the starting position.
This application is applied as 10 repetitions, 6 sets, and 1 minute rest between sets.
Following the MWM application, Mulligan talus stabilization taping is performed.
For this taping, the participants' ankles are placed on a stool at a height of 30 cm and their feet are placed in the dorsiflexion position.
The therapist starts taping from the plantar surface of the calcaneus using rigid tape and will wrap and stabilize the talus.
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Sham Comparator: Sham Group
Movement with Motion technique of Mulligan Concept to the ankle joint with lower amplitude and taping with minimal tension will be performed on the participants in the Sham Group.
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During joint mobilization with movement, the therapist will stabilize the ankle while performing knee flexion and ankle dorsiflexion by actively moving the center of mass to the affected side, but the shear force required to slide the tibia forward with the belt will not be given.
Placebo taping following the application will be applied in such a way that there is no stabilization effect without tension between the same start and end points.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Stride length
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
Stride length spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as a millimeter.
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Pre-intervention/sham and immediately after the intervention/sham
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Stride width
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
Stride width spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as a millimeter.
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Pre-intervention/sham and immediately after the intervention/sham
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Cadance
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
Cadance spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as the number of steps per minute.
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Pre-intervention/sham and immediately after the intervention/sham
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Walking speed
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
Walking speed spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as m/s.
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Pre-intervention/sham and immediately after the intervention/sham
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The symmetry of the center of pressure changes during walking
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
The symmetry of the center of pressure changes during walking spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as a millimeter.
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Pre-intervention/sham and immediately after the intervention/sham
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The maximum force on the feet during walking
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
The maximum force on the feet during walking spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as N/cm2.
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Pre-intervention/sham and immediately after the intervention/sham
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The distribution of pressure on the feet
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Spatiotemporal parameters of gait will be evaluated with the Zebris FDM-2 device.
The distribution of pressure on the feet spatiotemporal parameters of gait will be obtained from this platform.
The date will recorded as percentages.
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Pre-intervention/sham and immediately after the intervention/sham
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Balance
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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Zebris FDM-2 device will also be used for the evaluation of balance parameters.
Participants will be asked to stand on the device for 60 seconds without shoes, arms at their sides, eyes open and looking at a point 3 meters away.
As a result of the evaluation, changes in the center of pressure will be recorded.
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Pre-intervention/sham and immediately after the intervention/sham
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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10-meter walk test
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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The 10-meter walk test will be used to assess the walking speed of stroke patients.
Patients will be asked to walk a 10-meter track.
Walking times will be recorded in seconds.
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Pre-intervention/sham and immediately after the intervention/sham
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Timed up and go test
Time Frame: Pre-intervention/sham and immediately after the intervention/sham
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The timed get up and walk test will be used to measure the dynamic balance of individuals.
It includes the measurement of the time it takes for the participant to get up from the chair, walk 3 meters at their own pace, turn around, return to the chair and sit back in the chair.
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Pre-intervention/sham and immediately after the intervention/sham
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: İsmail Okur, Dr., Kütahya Health Sciences University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- An CM, Jo SO. Effects of Talocrural Mobilization with Movement on Ankle Strength, Mobility, and Weight-Bearing Ability in Hemiplegic Patients with Chronic Stroke: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2017 Jan;26(1):169-176. doi: 10.1016/j.jstrokecerebrovasdis.2016.09.005. Epub 2016 Oct 17.
- An CM, Won JI. Effects of ankle joint mobilization with movement and weight-bearing exercise on knee strength, ankle range of motion, and gait velocity in patients with stroke: a pilot study. J Phys Ther Sci. 2016 Jan;28(2):689-94. doi: 10.1589/jpts.28.689. Epub 2016 Feb 29.
- Altmis H, Oskay D, Elbasan B, Duzgun I, Tuna Z. Mobilization with movement and kinesio taping in knee arthritis-evaluation and outcomes. Int Orthop. 2018 Dec;42(12):2807-2815. doi: 10.1007/s00264-018-3938-3. Epub 2018 May 10.
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)
February 14, 2024
Primary Completion (Actual)
September 15, 2024
Study Completion (Actual)
October 11, 2024
Study Registration Dates
First Submitted
February 14, 2024
First Submitted That Met QC Criteria
March 15, 2024
First Posted (Actual)
March 19, 2024
Study Record Updates
Last Update Posted (Actual)
November 6, 2024
Last Update Submitted That Met QC Criteria
November 5, 2024
Last Verified
November 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHSU-2023/11
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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