Chronic StrokeNCT03974009
Calcaneal Taping on Balance, Gait and Range of Motion in Chronic Stroke Survivors
A study testing Calcaneal taping and Conventional therapy in people with Chronic Stroke, run by Asir John Samuel at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Calcaneal taping and Conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteIndia
- Study dates
- 2 Aug 2019to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Chronic Stroke(≥ 6 months)
- Modified Ashworth scale of the ankle (grade <2)
- Mini Mental examination score (minimum 24)
Who cannot join
- Cognition problems
- Balance disorders (vertigo, dizziness etc.)
- History of pain \& surgery at ankle joint
- Cases of fracture
- Neuropathic joints
- Diabetic foot
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Calcaneal Taping on Balance, Gait and Range of Motion in Patients With Chronic Stroke
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.
Read more
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.
Read the detailed description
- 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.
- 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
- Chronic Stroke
- Being tested
- Calcaneal taping, Sham taping, Conventional therapy
- Keywords
- Calcaneal taping, Balance, Gait
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcaneal tapingOther
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.
Sham tapingOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sham taping; Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2019
- Study start2 Aug 2019
- Primary completion18 Mar 2020
- Study completion19 Mar 2020
Why it stopped: Due to COVID-19 lockdown
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group pretest postest randomized control group design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asir John Samuel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Satkarjit K Jhandi, BPT, (MPT), Principal investigator, Department of Neurological Physiotherapy, MMIPRNidhi Sharma, MPT, Study director, Department of Neurological Physiotherapy, MMIPR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974009
- Sponsor's protocol ID
- MMDU/IEC/1466
- Other IDs
- U1111-1233-8844
- Status last verified
- Jun 2020
- First submitted
- 25 May 2019
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not decided yet.
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.
PubMed 29717946
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Calcaneal Taping on Balance, Gait and Range of Motion in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03974009
- Acronym / sponsor ID
- MMDU/IEC/1466
- Conditions
- Chronic Stroke
- Keywords
- Calcaneal taping, Balance, Gait
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to COVID-19 lockdown
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Asir John SamuelUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 4 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two group pretest postest randomized control group design
| Arm | Type | Receives |
|---|---|---|
| Calcaneal taping and Conventional therapy | Experimental | Other: Calcaneal taping, Other: Conventional therapyCalcaneal Taping Technique along with Conventional therapy will given to the patients for 3 days/week for 4 weeks. |
| Sham taping and Conventional therapy | Active comparator | Other: Sham taping, Other: Conventional therapySham taping along with Conventional therapy will given to the patients for 3 days/week for 4 weeks. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with Chronic Stroke(≥ 6 months)
- Modified Ashworth scale of the ankle (grade <2)
- Mini Mental examination score (minimum 24)
Key exclusion criteria (6 listed)
- Cognition problems
- Balance disorders (vertigo, dizziness etc.)
- History of pain \& surgery at ankle joint
- Cases of fracture
- Neuropathic joints
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcaneal tapingCalcaneal 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 | Calcaneal taping and Conventional therapy |
| Sham tapingSham 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 | Sham taping and Conventional therapy |
| Conventional therapyBalance 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. | Other | Calcaneal taping and Conventional therapy, Sham taping and Conventional therapy |
Primary outcome
Step length
Time frame: 2 weeks
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.
Stride Length
Time frame: 2 weeks
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.
Cadence
Time frame: 2 weeks
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.
Balance error scoring system test
Time frame: 2 weeks
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.
Timed Up & Go test
Time frame: 2 weeks
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.
Range of motion
Time frame: 2 weeks
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.
Results and safety
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Results publication: PubMed 29717946Park 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.
- Individual participant dataSharing planned: No. It is not decided yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Satkarjit K Jhandi, BPT, (MPT) principal investigator
Department of Neurological Physiotherapy, MMIPR
Nidhi Sharma, MPT study director
Department of Neurological Physiotherapy, MMIPR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcaneal taping and Conventional therapy in people with Chronic Stroke, run by Asir John Samuel at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to COVID-19 lockdown). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03974009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.