NCT05425212

Brief Summary

In stroke; gait deviation occurs usually due to weakness in the tibialis anterior and over activation/spasticity of planter flexors. The lack of ability to dorsiflex properly contributes to foot drop that leads to the issue in proper foot clearance. This results in decreased walking speed, decreased stance and asymmetrical step length. If these issues will be addressed through application of kinesio tape and functional activation pattern throughout the gait cycle; this may improve lower limb kinematics in terms of gait parameters and dynamic balance. Therefore, current study gives us insight to gain the combined effects of KT and functional activation patterns in chronic stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Apr 2022

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

Study Start

First participant enrolled

April 4, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2022

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

5 months

First QC Date

June 15, 2022

Last Update Submit

January 28, 2024

Conditions

Keywords

tape, gait, balance, stroke

Outcome Measures

Primary Outcomes (5)

  • 6 Minute Walk Test

    Use: Clinically, the 6-Minute Walk Test (6MWT) is a known beneficial tool to evaluate walking endurance in patients with post stroke hemiparesis. It provides a criterion to judge whether people can walk independently in the community environment. In general, walking capacity after stroke influences the outcome of the 6MWT and may be potentially meaningful to demonstrate clinical benefit from training.

    4th week

  • Timed Up and Go

    Use: to determine fall risk and measure the progress of balance, sit to stand and walking.

    4th week

  • Modified Ashworth Scale

    Use: To assess muscle tone. It is a six point scale with scores ranging from 0 - 4, where low score represents normal muscle tone and high score represents spasticity.

    4th week

  • Observational Gait Scale (OGS)

    OGS was reported to have very good inter-rater reliability, however only the sagittal plane (ankle/foot and knee joints) items scored maximum agreement. (19) OGS had acceptable inter rater and intra rater reliability for knee and foot position in midstance, initial foot contact and heel rise. There were also lower intra rater reliabilities found for hindfoot position and base of support.

    4th week

  • Berg Balance Scale

    Use: Objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg Balance Scale can be used to predict the degree of improvement in walking for patients with stroke.

    4th week

Study Arms (2)

Functional activation with kinesio tapping

EXPERIMENTAL

given 5 cm wide kinesio tape at tibialis anterior and gastrocnemius to facilitate dorsiflexion of the ankle and inhibit planter flexion simultaneously along with conventional treatment.

Other: Functional activation with kinesio tapping

Conventional physical therapy

ACTIVE COMPARATOR

strengthening and stretching, combined with Ankle ranges and Hip strengthening. (6) The exercises performed will be Calf stretches, Heel and Toe raises, Hip marching in sitting/standing; Heel walk; Pebble picking; Single leg standing; and Ankle range of motions

Other: Conventional physical therapy

Interventions

These exercises will be carried out thrice a week for 4 weeks. The exercises will be performed for approximately 35-45 minutes, 1 to 2 times a day, in sitting or standing position

Functional activation with kinesio tapping

strengthening and stretching, combined with Ankle ranges and Hip strengthening. (6) The exercises performed will be Calf stretches, Heel and Toe raises, Hip marching in sitting/standing; 4 days a week for 4 weeks

Conventional physical therapy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ● Both male and female, with age between 45-65 years
  • Patients diagnosed with stroke for at least 6 months confirmed with MRI or CT.
  • Patients depicting reduced range of motion at ankle joint after stroke causing gait disturbances.
  • Ability to walk at least 3 meters by itself with or without assistive device.
  • No surgical procedure performed on lower limbs.
  • Normal vision with or without correction by spectacles or contact lenses
  • Patients with spasticity \<2/5 on modified Ashworth scale

You may not qualify if:

  • Patients with pre-existing neurological conditions who are Unable to understand and answer a simple verbal command.
  • Patients with deep vein thrombosis (DVT). Using KT near the DVT can increase mobility and blood flow. This may cause the blood clot to dislodge and may put you at risk for pulmonary embolism.
  • Cognitively impaired patients.
  • Patients with open wounds in the lower extremity.
  • Patients with ankle fracture or any skin allergy to adhesives.
  • Patients with sensory loss due to any pathology, altered sensation such as in peripheral neuropathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahore general Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • Song S, Park J, Song G, Lee S, Jo Y, Jin M, Lee D, Jung S, Hong S, Lee S, Pyo S, Lee G. Usability of the Thera-Band(R) to improve foot drop in stroke survivors. NeuroRehabilitation. 2018;42(4):505-510. doi: 10.3233/NRE-172338.

    PMID: 29660954BACKGROUND
  • Lee D, Bae Y. Short-Term Effect of Kinesio Taping of Lower-Leg Proprioceptive Neuromuscular Facilitation Pattern on Gait Parameter and Dynamic Balance in Chronic Stroke with Foot Drop. Healthcare (Basel). 2021 Mar 3;9(3):271. doi: 10.3390/healthcare9030271.

    PMID: 33802448BACKGROUND
  • In T, Lee K, Song C. Virtual Reality Reflection Therapy Improves Balance and Gait in Patients with Chronic Stroke: Randomized Controlled Trials. Med Sci Monit. 2016 Oct 28;22:4046-4053. doi: 10.12659/msm.898157.

    PMID: 27791207BACKGROUND
  • van Duijnhoven HJ, Heeren A, Peters MA, Veerbeek JM, Kwakkel G, Geurts AC, Weerdesteyn V. Effects of Exercise Therapy on Balance Capacity in Chronic Stroke: Systematic Review and Meta-Analysis. Stroke. 2016 Oct;47(10):2603-10. doi: 10.1161/STROKEAHA.116.013839. Epub 2016 Sep 15.

    PMID: 27633021BACKGROUND
  • Huzmeli I, Sari Z, Hallaceli H, Gokcek O, Davut S. Immediate Effect of Kinesiology Tape on Functionality, Static and Dynamic Balance, Exercise Capacity, and Posture in Users of High-Heeled Shoes. J Am Podiatr Med Assoc. 2023 Jul-Aug;113(4):21-037. doi: 10.7547/21-037.

    PMID: 34698768BACKGROUND
  • Shin YJ, Lee JH, Choe YW, Kim MK. Immediate effects of ankle eversion taping on gait ability of chronic stroke patients. J Bodyw Mov Ther. 2019 Jul;23(3):671-677. doi: 10.1016/j.jbmt.2018.06.008. Epub 2018 Jun 28.

    PMID: 31563387BACKGROUND
  • Choi SH, Lim CG. Immediate Effects of Ankle Non-elastic Taping on Balance and Gait Ability in Patients With Chronic Stroke: A Randomized, Controlled Trial. J Manipulative Physiol Ther. 2020 Nov-Dec;43(9):922-929. doi: 10.1016/j.jmpt.2019.12.007. Epub 2020 Jul 16.

    PMID: 32684325BACKGROUND
  • Hu Y, Zhong D, Xiao Q, Chen Q, Li J, Jin R. Kinesio Taping for Balance Function after Stroke: A Systematic Review and Meta-Analysis. Evid Based Complement Alternat Med. 2019 Jul 16;2019:8470235. doi: 10.1155/2019/8470235. eCollection 2019.

    PMID: 31379969BACKGROUND
  • Agarwala P, Salzman SH. Six-Minute Walk Test: Clinical Role, Technique, Coding, and Reimbursement. Chest. 2020 Mar;157(3):603-611. doi: 10.1016/j.chest.2019.10.014. Epub 2019 Nov 2.

    PMID: 31689414BACKGROUND
  • Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.

    PMID: 15788341BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Binash Afzal, PHD*

    Riphah international university lahore campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 15, 2022

First Posted

June 21, 2022

Study Start

April 4, 2022

Primary Completion

September 15, 2022

Study Completion

October 20, 2022

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations