NCT06318624

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 14, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 19, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

7 months

First QC Date

February 14, 2024

Last Update Submit

November 5, 2024

Conditions

Keywords

strokegaitmobilisationMulliganbalance

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • 10-meter walk test

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

  • Timed up and go test

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

Movement with Motion technique of Mulligan Concept to the ankle joint and taping will be performed on the participants in the Intervention Group.

Other: Mobilisation with Movement and Taping

Sham Group

SHAM COMPARATOR

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.

Other: Sham

Interventions

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.

Intervention Group
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.

Sham Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 27065565BACKGROUND
  • 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.

    PMID: 29750315BACKGROUND
  • 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.

    PMID: 27765557BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Movementsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • İsmail Okur, Dr.

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
There are 2 different groups in the study. One of them is the intervention group and the other is the sham group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

February 14, 2024

First Posted

March 19, 2024

Study Start

February 14, 2024

Primary Completion

September 15, 2024

Study Completion

October 11, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations