Clinical trial NCT03974009: Calcaneal Taping on Balance, Gait and Range of Motion in Chronic Stroke Survivors
Official title: Effect of Calcaneal Taping on Balance, Gait and Range of Motion in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Stroke
Keywords: Calcaneal taping
Balance
Gait
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2019-06-04
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two group pretest postest randomized control group design
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Step length
timeFrame: 2 weeks
measure: Stride Length
timeFrame: 2 weeks
measure: Cadence
timeFrame: 2 weeks
measure: Balance error scoring system test
timeFrame: 2 weeks
measure: Timed Up & Go test
timeFrame: 2 weeks
measure: Range of motion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ambala
country: India
facility: Maharishi Markandeshwar Hospital, Mullana
state: Haryana
Study officials:
affiliation: Department of Neurological Physiotherapy, MMIPR
name: Satkarjit K Jhandi, BPT, (MPT)
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurological Physiotherapy, MMIPR
name: Nidhi Sharma, MPT
role: STUDY_DIRECTOR
References:
citation: 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.