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StrokeNCT05425212

Kinesio Taping Along With Functional Activation Pattern in Stroke Patients

A study testing Functional activation with kinesio tapping and Conventional physical therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

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

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. Read more about this study

Who is it for?
Ages 45 to 65 years
Conditions the study is for
Stroke
What is being tested?
Functional activation with kinesio tapping and Conventional physical therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 sitePakistan
Study dates
4 Apr 2022to 20 Oct 2022
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 45 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ● 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Lahore general Hospital

    Lahore, Punjab Province, 54000

Other trials in Pakistan

About this study

Official title: Effect of Kinesio Taping Along With Functional Activation Pattern on Gait Parameters and Dynamic Balance in Stroke Patients

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.

Read the detailed description

Stroke is a cerebrovascular disease caused by ischemia or hemorrhage of the brain tissues. Chronic stroke patients usually present compensatory movement of the hip, knee and ankle instead of having normal movement. Stroke survivors face difficulty in clearing off the ground. This abnormality results from weakness of ankle dorsiflexors or excessive activity of plantar flexors. Ineffective ankle dorsiflexion may result in an abnormal gait pattern. The focus of stroke rehabilitation is largely on the recovery of impaired movements and functions as it often leads to balance impairment, impaired postural control, mobility and gait abnormalities. Various approaches have been used to improve these long-term disabilities. Two out of those are taping and functional activation. Taping is used to improve motor control, postural stability and joint alignment adjustment. This happens through facilitation of ankle dorsiflexors, whereas functional activation improves gait and balance.In chronic movement disability, deficits of foot and ankle proprioception are most highly associated with falls. The disturbance in motor function can cause muscle weakness, spasticity, and a decrease in the ability to maintain balance, as well as abnormal gait patterns. There are different imaging modalities (magnetic resonance imaging or computed tomography) used for the confirm diagnosis of stroke.

In a recent study, application of Kinesio tape has been reported to improve balance ability and gait performance. It restricts the excessive movements on the joints. It also acts as a facilitator helping the weak muscle to perform movement. In our study, we will apply Kinesio tape to the Tibialis Anterior Muscle (Prime dorsiflexor) and to the gastrocnemius. KT is a thin, air permeable, water resistant and elastic adhesive tape which can be stretched to up to 120-140% of its resting length. The protective effect provided by KT is purportedly related to its ability to improve proprioception by stimulating mechanoreceptors located in muscle, tendon, joint capsule or skin.Therefore, strengthening of muscle and improvement of range of motion of the ankle are also required to improve balance and gait ability.

Activation of the tibialis anterior muscle in particular enables enough dorsiflexion to prevent the toes from dragging on the ground during the swinging phase. According to recent studies, the application of Kinesio tape can reduce the hyperactivity of the gastrocnemius and increase the activity of the tibialis anterior (TA) in the correction of foot drop (such as neutralizing the foot), and aid in the correction of equinus deformity, with a more positive effect on joint angle and walking ability in stroke patients with foot drop. Applying a Kinesio tape to the lower extremity during post-stroke rehabilitation is reported to relieve lower-extremity spasticity, improving lower-extremity motor function, improving balance, and enhance ambulation and gait parameters in patients.

This will be a randomized controlled trial and will recruit patients through convenience sampling. Diagnosed patients of Stroke will be confirmed for inclusion through Computed Tomography or Magnetic Resonance Imaging. The patients will be divided into 2 groups. Group 1 will receive conventional treatment and Group 2 will receive taping and functional activation along with Conventional Treatment. This treatment will be given for 30-40 mins for 3 days a week for 4 continuous weeks. The outcome measures will be 6 Min walk test (test- retest reliability for those require an assistive device to walk (ICC = 0.914, TUG (timed up and go) for mobility, Berg Balance Scale (for balance and fall risks), OGA (Observational Gait Analysis) for gait parameters (cadence, gait velocity, step length) before and after the interventions. The data will be analyzed using SPPS software version 25.

Conditions
Stroke
Being tested
Functional activation with kinesio tapping, Conventional physical therapy
Keywords
tape, gait, balance, stroke
Medical subject headings
Stroke

What participants receive

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

  • Functional activation with kinesio tappingOther

    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

  • Conventional physical therapyOther

    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

Study groups in NCT05425212
Study groupRoleWhat they receive
Functional activation with kinesio tappingExperimentalgiven 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.
Receives: Other: Functional activation with kinesio tapping
Conventional physical therapyActive comparatorstrengthening 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
Receives: Other: Conventional physical therapy

What is being measured

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

  1. 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.

    Measured: 4th week

  2. Timed Up and Go

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

    Measured: 4th week

  3. 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.

    Measured: 4th week

  4. 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.

    Measured: 4th week

  5. 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.

    Measured: 4th week

Timeline

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

  1. First posted21 Jun 2022
  2. Study start4 Apr 2022
  3. Primary completion15 Sep 2022
  4. Study completion20 Oct 2022

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
Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425212
Sponsor's protocol ID
REC/Lhr/22/0215 Anum Sajid
Status last verified
Jan 2024
First submitted
15 Jun 2022
Last updated
30 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29660954
  • 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.

    PubMed 33802448
  • 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.

    PubMed 27791207
  • 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.

    PubMed 27633021
  • 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.

    PubMed 34698768
  • 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.

    PubMed 31563387
  • 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.

    PubMed 32684325
  • 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.

    PubMed 31379969
  • 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.

    PubMed 31689414
  • 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.

    PubMed 15788341

Questions about this trial

What is this clinical trial studying?

A study testing Functional activation with kinesio tapping and Conventional physical therapy in people with Stroke, run by Riphah International University at 1 site in Pakistan.

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 7 inclusion and 6 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 30 Jan 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 Pakistan. 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. 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?

6 Minute Walk Test (time frame: 4th week). The study lists 5 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 NCT05425212, which also lists 10 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 30 Jan 2024.

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