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.
Condition or disease | Intervention/treatment | Phase |
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Chronic Stroke | Other: Calcaneal taping Other: Sham taping Other: Conventional therapy | Not Applicable |
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.
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 18 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Two group pretest postest randomized control group design |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Effect of Calcaneal Taping on Balance, Gait and Range of Motion in Patients With Chronic Stroke |
Actual Study Start Date : | August 2, 2019 |
Actual Primary Completion Date : | March 18, 2020 |
Actual Study Completion Date : | March 19, 2020 |
Arm | Intervention/treatment |
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Experimental: Calcaneal taping and Conventional therapy
Calcaneal Taping Technique along with Conventional therapy will given to the patients for 3 days/week for 4 weeks.
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Other: 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.
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.
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Active Comparator: Sham taping and Conventional therapy
Sham taping along with Conventional therapy will given to the patients for 3 days/week for 4 weeks.
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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.
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.
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Ages Eligible for Study: | 40 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India | |
Maharishi Markandeshwar Hospital, Mullana | |
Ambala, Haryana, India, 133207 |
Principal Investigator: | Satkarjit K Jhandi, BPT, (MPT) | Department of Neurological Physiotherapy, MMIPR | |
Study Director: | Nidhi Sharma, MPT | Department of Neurological Physiotherapy, MMIPR |
Tracking Information | |||||||
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First Submitted Date ICMJE | May 25, 2019 | ||||||
First Posted Date ICMJE | June 4, 2019 | ||||||
Last Update Posted Date | June 16, 2020 | ||||||
Actual Study Start Date ICMJE | August 2, 2019 | ||||||
Actual Primary Completion Date | March 18, 2020 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Calcaneal Taping on Balance, Gait and Range of Motion in Chronic Stroke Survivors | ||||||
Official Title ICMJE | Effect of Calcaneal Taping on Balance, Gait and Range of Motion in Patients With Chronic Stroke | ||||||
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. |
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Detailed Description |
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Two group pretest postest randomized control group design Masking: Single (Participant)Primary Purpose: Treatment |
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Condition ICMJE | Chronic Stroke | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | 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. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE |
18 | ||||||
Original Estimated Enrollment ICMJE |
26 | ||||||
Actual Study Completion Date ICMJE | March 19, 2020 | ||||||
Actual Primary Completion Date | March 18, 2020 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 70 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | India | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT03974009 | ||||||
Other Study ID Numbers ICMJE | MMDU/IEC/1466 U1111-1233-8844 ( Other Identifier: UTN by WHO International Clinical Trial Registry Platform ) |
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Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Asir John Samuel, Maharishi Markendeswar University (Deemed to be University) | ||||||
Study Sponsor ICMJE | Asir John Samuel | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Maharishi Markendeswar University (Deemed to be University) | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |