Calcaneal Taping on Balance, Gait and Range of Motion in Chronic Stroke Survivors

NCT ID: NCT03974009

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-02

Study Completion Date

2020-03-19

Brief Summary

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Background:

Stroke is highly prevalence neurological condition and causing many disabilities worldwide. Impaired Balance, Gait disability and limited Range of motion are the major problems in the chronic stage of stroke. Taping technique increases the sense of proprioception and improves the accurate position of joint by limiting or facilitating the movements. Calcaneal taping technique helps to correct the determinants of gait, improvement of balance and ankle range of motion.

Aim:

The goal of the study is to verify the effect of calcaneal taping technique on balance, gait and range of motion in patients with chronic stroke.

Methods:

This randomized clinical trial study will recruit patients with chronic stroke (≥6 months) on the basis of selection criteria. Patients with age between 40-80 years and grade ≥ 2 of modified asworth scale for ankle joint will be included. Patients with any Cognition problems, balance disorders, any case of fracture and history of surgery in ankle, diabetic foot and neuropathic joints will be excluded from the study. Participants will be selected randomly by criterion based sampling method and will be allocated into two groups (experimental and control group).Experimental group will receive calcaneal taping and conventional therapy whereas control group will receive sham taping and conventional therapy. Assessment of balance, gait and range of motion will be taken prior and after the intervention.

Data Analysis:

Estimation of normal distribution will be done by Shapiro Wilk test. Descriptive statistics data will be expressed as mean ± standard deviation and median ± interquartile range, based on the normality. Between groups comparison will be done by independent t-test /Mann Whitney U test and within group comparison will be done by Paired t-test/ Wilcoxon signed rank test.

Detailed Description

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1. Introduction

Stroke leads to many disabilities such as balance impairment,weakness in various groups of muscles, impairment of gait parameters and limitations of range of motion.Balance and gait disability are the main impairments among chronic stroke survivors.Lower extremity dysfunctions affect the walking ability and balance. Ankle dorsiflexion (weakness in dorsiflexor muscles) and increase in the tone of triceps surae (plantar flexor muscles) is the major leading cause of impairment of balance and gait parameters.Application of taping on calcaneus (favouring dorsiflexion \& eversion) will provide normal determinants of gait and improve balance, as it significantly improving the accurate joint position by limiting or facilitating the movement.

1.1.Problem Statement: In patients with chronic stroke immediate effects of different types of taping technique \& targeted areas to determine its impact on balance , gait and range of motion has been checked.This study thus aims to evaluate the long term effects and application of calcaneal taping in the improvement of balance ,gait and range of motion in chronic stroke survivors .

1.2.Purpose of the study: The study is targeting the calcaneus bone for the application of taping technique in patients with chronic stroke for the improvement of balance, gait and range of motion.

1.3.Objectives of the study: To improve the balance (static \& dynamic), gait parameters and ankle joint range of motion by the application of calcaneal taping in patients with chronic stroke.
2. Procedure:

Patients with chronic stroke on the basis of selection criteria will be randomly selected for both groups(experimental and control group).Procedure will be explained to the patients and written consent will be taken from them.

Outcome measurements will be taken prior and after the intervention.Foot print method will be used for the analysis of gait parameters( step length, stride length and cadence ).Balance error scoring system (BESS) will be used for the assessment of static balance.Timed Up \& Go test (TUG) will be performed for the assessment of dynamic balance.Universal goniometer will be used for the measurement of ankle joint range of motion.

Interventions: In experimental group - Calcaneal taping will be provide to the patients by focusing the dorsiflexion with eversion (with stretch) in long sitting position foot out of edge. Conventional therapy (muscle strengthening exercises, balance related activities ) will be given to the patients.

In control group- Sham taping (without stretch) will be provide and conventional therapy (muscle strengthening exercises, balance related activities ) to the patients.

Conditions

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Chronic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two group pretest postest randomized control group design
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Calcaneal taping and Conventional therapy

Calcaneal Taping Technique along with Conventional therapy will given to the patients for 3 days/week for 4 weeks.

Group Type EXPERIMENTAL

Calcaneal taping

Intervention Type OTHER

Calcaneal taping will be given in long sitting position foot out of the edge.BSN Medical Leukotape P Sports Tape (3.8cm×137m,1.5inch× 15yds) on focusing the calcaneus with the aim of choosing dorsiflexion with eversion. First strap of tape will be applied below the medial malleolus,stretch towards lateral malleolus on affected side. Second strap of tape will be applied repetitively placing the first strap,another will be applied to fix the small tapes.

Conventional therapy

Intervention Type OTHER

Balance activities (Forward, backward and sideways walking in between 2 parallel lines;Ball kicking against wall(reducing upper limb support)to raising the distance from the wall, kicking to the fixed target; Obstacle walking and Strengthening exercises (Sit to Stand from several heights of chair, Forward \& backward and sideward stepping onto blocks of several heights. Each acitivity will be given for 5 minutes.

Sham taping and Conventional therapy

Sham taping along with Conventional therapy will given to the patients for 3 days/week for 4 weeks.

Group Type ACTIVE_COMPARATOR

Sham taping

Intervention Type OTHER

Sham taping will be given to the control group patients.Simple clinical tape will be applied on calcaneus without stretch.It will be applied for 3 days/week for 4 weeks.

Conventional therapy

Intervention Type OTHER

Balance activities (Forward, backward and sideways walking in between 2 parallel lines;Ball kicking against wall(reducing upper limb support)to raising the distance from the wall, kicking to the fixed target; Obstacle walking and Strengthening exercises (Sit to Stand from several heights of chair, Forward \& backward and sideward stepping onto blocks of several heights. Each acitivity will be given for 5 minutes.

Interventions

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Calcaneal taping

Calcaneal taping will be given in long sitting position foot out of the edge.BSN Medical Leukotape P Sports Tape (3.8cm×137m,1.5inch× 15yds) on focusing the calcaneus with the aim of choosing dorsiflexion with eversion. First strap of tape will be applied below the medial malleolus,stretch towards lateral malleolus on affected side. Second strap of tape will be applied repetitively placing the first strap,another will be applied to fix the small tapes.

Intervention Type OTHER

Sham taping

Sham taping will be given to the control group patients.Simple clinical tape will be applied on calcaneus without stretch.It will be applied for 3 days/week for 4 weeks.

Intervention Type OTHER

Conventional therapy

Balance activities (Forward, backward and sideways walking in between 2 parallel lines;Ball kicking against wall(reducing upper limb support)to raising the distance from the wall, kicking to the fixed target; Obstacle walking and Strengthening exercises (Sit to Stand from several heights of chair, Forward \& backward and sideward stepping onto blocks of several heights. Each acitivity will be given for 5 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with Chronic Stroke(≥ 6 months)
* Modified Ashworth scale of the ankle (grade \<2)
* Mini Mental examination score (minimum 24)

Exclusion Criteria

* Cognition problems
* Balance disorders (vertigo, dizziness etc.)
* History of pain \& surgery at ankle joint
* Cases of fracture
* Neuropathic joints
* Diabetic foot
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asir John Samuel

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Supervisor and Associate Professor,Department of Pediatric and Neonatal Physiotherapy

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Satkarjit K Jhandi, BPT, (MPT)

Role: PRINCIPAL_INVESTIGATOR

Department of Neurological Physiotherapy, MMIPR

Nidhi Sharma, MPT

Role: STUDY_DIRECTOR

Department of Neurological Physiotherapy, MMIPR

Locations

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Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, India

Site Status

Countries

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India

References

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Park D, Lee JH, Kang TW, Cynn HS. Immediate effects of talus-stabilizing taping on balance and gait parameters in patients with chronic stroke: a cross-sectional study. Top Stroke Rehabil. 2018 Sep;25(6):417-423. doi: 10.1080/10749357.2018.1466972. Epub 2018 May 2.

Reference Type RESULT
PMID: 29717946 (View on PubMed)

Other Identifiers

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U1111-1233-8844

Identifier Type: OTHER

Identifier Source: secondary_id

MMDU/IEC/1466

Identifier Type: -

Identifier Source: org_study_id

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