- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05425212
Kinesio Taping Along With Functional Activation Pattern in Stroke Patients
Effect of Kinesio Taping Along With Functional Activation Pattern on Gait Parameters and Dynamic Balance in Stroke Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Lahore General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
● 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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Functional activation with kinesio tapping
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.
|
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
|
|
Active Comparator: Conventional physical therapy
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 Minute Walk Test
Time Frame: 4th week
|
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
Time Frame: 4th week
|
Use: to determine fall risk and measure the progress of balance, sit to stand and walking.
|
4th week
|
|
Modified Ashworth Scale
Time Frame: 4th week
|
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)
Time Frame: 4th week
|
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
Time Frame: 4th week
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Binash Afzal, PHD*, Riphah International University Lahore Campus
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/Lhr/22/0215 Anum Sajid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
Clinical Trials on Functional activation with kinesio tapping
-
Majmaah UniversityScientific research unit, AIHMS New DelhiCompletedOsteo Arthritis Knee | Quadriceps Muscle AtrophyIndia
-
NCS University SystemCompleted
-
Universidade Federal do Rio Grande do NorteUnknown
-
Universidade Federal do Rio Grande do NorteCompleted
-
The University of Hong KongUnknownDevelopmental Coordination DisorderHong Kong
-
Universidade Federal do Rio Grande do NorteCompletedMuscle Soreness | BandagesBrazil
-
Universidade Federal do Rio Grande do NorteCompletedNeuromuscular Performance, Balance and FunctionBrazil
-
Riphah International UniversityRecruitingPatellofemoral Pain SyndromePakistan
-
Universidade Federal do Rio Grande do NorteUnknown
-
Rodrigo Antonio Carvalho AndrausNot yet recruiting