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

NCT03974009 | Terminated

• 2 other identifiers: MMDU/IEC/1466U1111-1233-8844
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Keywords

Calcaneal taping; Balance; Gait

Outcome Measures

Primary Outcomes (6)

• Step length

  Foot print method is used for the analysis of step length(cm),gait parameter.Patients will be asked to walk along horizontal 10 meters long pathway with lateral borders in their normal speed.It is the distance measured from the heel print of one foot to the heel print of another foot.

  2 weeks

• Stride Length

  Foot print method is used for the analysis of stride length(cm),gait parameter .Patients will be asked to walk along horizontal 10 meters long pathway with lateral borders in their normal speed.Measurement will taken from heel to heel,it is the distance between the successive placements of the same foot.

  2 weeks

• Cadence

  Foot print method is used for the assessment of cadence.It will be assessed by the number of steps taken by the patients in one minute.Patients will be asked to walk along horizontal 10 meters long pathway with lateral borders in their normal speed.

  2 weeks

• Balance error scoring system test

  It is used for the assessment of static balance.Patients will stand without shoe, with hand placed over hips \& eyes closed for 20 seconds on foam and firm surface. The test will be evaluated in 3 postures- double leg stance with feet together, single leg stance on non-dominant foot and tandem stance. Errors will be noted for every single 20 seconds trial. Lifting the hands off the iliac crests; opening of eyes; striding, fall; movement of hip joint more than 30⁰ of abduction; lifting the forefoot or heel; or remaining out of test position for more than 5 seconds. The highest possible score for every single stance will be 10. For statistical analysis the total score will be taken.

  2 weeks

• Timed Up & Go test

  This test will be performed by the patients for the dynamic balance assessment.They will be seated on the chair and will be asked for stand up and walk in their normal speed safely for 3 meters.Then turn \& come back to the chair and sit down.Time will be noted by stopwatch, from the point where patient will get up from the chair until return back to the starting position.

  2 weeks

• Range of motion

  Patients will be in high sitting position, measurement of ankle (dorsiflexion \& plantarflexion) and subtalar joint ( eversion \& inversion)range of motion will be taken by universal goniometer in degrees.

  2 weeks

Study Arms (2)

Calcaneal taping and Conventional therapy

EXPERIMENTAL

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

Other: Calcaneal taping; Other: Conventional therapy

Sham taping and Conventional therapy

ACTIVE COMPARATOR

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

Other: Sham taping; Other: Conventional therapy

Interventions

Calcaneal taping 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.

Calcaneal taping and Conventional therapy

Sham taping 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.

Sham taping and Conventional therapy

Conventional therapy 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.

Calcaneal taping and Conventional therapy; Sham taping and Conventional therapy

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Asir John Samuel: lead

Study Sites (1)

Maharishi Markandeshwar Hospital, Mullana

Ambāla, Haryana, 133207, India

Location

Related Publications (1)

• 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.

  PMID: 29717946 RESULT

Study Officials

• Satkarjit K Jhandi, BPT, (MPT)

  Department of Neurological Physiotherapy, MMIPR

  PRINCIPAL INVESTIGATOR

• Nidhi Sharma, MPT

  Department of Neurological Physiotherapy, MMIPR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Supervisor and Associate Professor,Department of Pediatric and Neonatal Physiotherapy

Model Details: Two group pretest postest randomized control group design

Study Record Dates

• First Submitted: May 25, 2019
• First Posted: June 4, 2019
• Study Start: August 2, 2019
• Primary Completion: March 18, 2020
• Study Completion: March 19, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)