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Completed

NCT Number: NCT05425212

Kinesio Taping Along With Functional Activation Pattern 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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahore general Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional activation with kinesio tapping

Other

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 therapy

Other

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

Primary outcomes

  1. 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.

  2. Timed Up and Go

    Time frame: 4th week

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

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jun 21, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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