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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06318624
Other study ID # KHSU-2023/11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 14, 2024
Est. completion date October 11, 2024

Study information

Verified date March 2024
Source Kutahya Health Sciences University
Contact Ismail Okur, Dr
Phone +905444548950
Email fzt.ismailokur@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date October 11, 2024
Est. primary completion date September 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. Having a unilateral stroke for more than three months, 2. Being able to walk 10 meters without an assistive device, 3. Being able to walk unassisted before having a stroke, 4. Having a score of 3 or lower on the Modified Ashworth Scale (MAS), 5. Be able to follow simple verbal instructions, 6. Being Volunteer Exclusion Criteria: 1. Having had more than one stroke, 2. Cerebellar involvement, 3. Having severe visual impairment, 4. Having cognitive impairment, 5. Severe aphasia, 6. Apraxia, 7. Having contraindications for joint mobilization (e.g. ankle hypermobility, trauma, inflammation), 8. Have significant lower limb problems such as fractures or arthritis, 9. Having undergone musculoskeletal surgery less than 6 months ago, 10. Having joint contracture in the paretic ankle that prevents walking.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mobilisation with Movement and Taping
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.
Sham
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.

Locations

Country Name City State
Turkey Kutahya Health Sciences University Kütahya

Sponsors (1)

Lead Sponsor Collaborator
Kutahya Health Sciences University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stride length 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. Pre-intervention/sham and immediately after the intervention/sham
Primary Stride width 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. Pre-intervention/sham and immediately after the intervention/sham
Primary Cadance 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. Pre-intervention/sham and immediately after the intervention/sham
Primary Walking speed 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. Pre-intervention/sham and immediately after the intervention/sham
Primary The symmetry of the center of pressure changes during walking 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. Pre-intervention/sham and immediately after the intervention/sham
Primary The maximum force on the feet during walking 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. Pre-intervention/sham and immediately after the intervention/sham
Primary The distribution of pressure on the feet 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. Pre-intervention/sham and immediately after the intervention/sham
Primary Balance 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. Pre-intervention/sham and immediately after the intervention/sham
Secondary 10-meter walk test 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. Pre-intervention/sham and immediately after the intervention/sham
Secondary Timed up and go test 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. Pre-intervention/sham and immediately after the intervention/sham
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