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StrokeNCT06318624

Immediate Effects of Ankle MWM and Taping on Gait and Balance in Stroke Patients

A study testing Mobilisation with Movement and Taping in people with Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Stroke
What is being tested?
Mobilisation with Movement and Taping
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
14 Feb 2024to 11 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Having had more than one stroke,
  • Cerebellar involvement,
  • Having severe visual impairment,
  • Having cognitive impairment,
  • Severe aphasia,
  • Apraxia,
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Kutahya Health Sciences University

    Kütahya, 43100

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Conditions
Stroke
Being tested
Mobilisation with Movement and Taping, Sham
Keywords
stroke, gait, mobilisation, Mulligan, balance
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mobilisation with Movement and TapingOther

    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.

  • ShamOther

    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.

Study groups in NCT06318624
Study groupRoleWhat they receive
Intervention GroupExperimentalMovement with Motion technique of Mulligan Concept to the ankle joint and taping will be performed on the participants in the Intervention Group.
Receives: Other: Mobilisation with Movement and Taping
Sham GroupSham comparatorMovement 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.
Receives: Other: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  2. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  3. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  4. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  5. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  6. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  7. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  8. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

Secondary outcomes (2)

  1. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

  2. 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.

    Measured: Pre-intervention/sham and immediately after the intervention/sham

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start14 Feb 2024
  3. Primary completion15 Sep 2024
  4. Study completion11 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06318624
Sponsor's protocol ID
KHSU-2023/11
Status last verified
Nov 2024
First submitted
14 Feb 2024
Last updated
6 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27065565

  • 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.

    PubMed 29750315

  • 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.

    PubMed 27765557

Questions about this trial

What is this clinical trial studying?

A study testing Mobilisation with Movement and Taping in people with Stroke, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stride length (time frame: Pre-intervention/sham and immediately after the intervention/sham). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06318624, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.

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