| CTRI Number |
CTRI/2025/08/092816 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of kinesio taping and Mc-connell taping on knee hyperextension and gait parameters in individuals with stroke using kinovea software and wisconsin gait scale. |
|
Scientific Title of Study
|
Comparing the efficacy of kinesio and Mc-connell taping on knee hyperextension and gait parameters in individuals with stroke. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prachi Bhanushali |
| Designation |
Phd scholar |
| Affiliation |
Bharati vidyapeeth Deemed university Medical college and hospital sangli |
| Address |
OPD NO-18 Neurophysiotherapy Department Bharati vidyapeeth (deemed to be university) Medical college and hospital,sangli
sangli-416416
Maharashtra
India
Sangli
MAHARASHTRA
416416
India |
| Phone |
9284193198 |
| Fax |
|
| Email |
prachibhanushali241@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shilpa khandare |
| Designation |
Professor |
| Affiliation |
|
| Address |
OPD NO -18 NEUROPHYSIOTHERAPY OPD BHARATI VIDYAPEETH (DEEMED TO BE UNIVERITY)
SANGLI 416416
MAHARASHTRA
INDIA
Sangli
MAHARASHTRA
416416
India |
| Phone |
08149853651 |
| Fax |
|
| Email |
shilpa.khandare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prachi Bhanushali |
| Designation |
Phd scholar |
| Affiliation |
Bharati vidyapeeth Deemed university Medical college and hospital sangli |
| Address |
OPD NO-18 Neurophysiotherapy Department Bharati vidyapeeth (deemed to be university) Medical college and hospital,sangli
sangli-416416
Maharashtra
India
Sangli
MAHARASHTRA
416416
India |
| Phone |
9284193198 |
| Fax |
|
| Email |
prachibhanushali241@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO-18 Neurophysiotherapy Department Bharati vidyapeeth (deemed to be university) Medical college and hospital,sangli
sangli-416416
Maharashtra
India |
|
|
Primary Sponsor
|
| Name |
Prachi Bhanushali |
| Address |
OPD NO-18 Neurophysiotherapy Department Bharati vidyapeeth (deemed to be university) Medical college and hospital,sangli
sangli-416416
Maharashtra
India |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prachi Bhanushali |
Bharati Vidyapeeth (deemed to be university) Medical College and Hospital |
OPD NO-18 Neurophysiotherapy Department.
Sangli
MAHARASHTRA |
9284193198
prachibhanushali241@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G931||Anoxic brain damage, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
kinesiotaping along with the routine physiotherapy with prowling.
|
This study involves post-stroke subjects with knee hyperextension. Eligible participants will be screened based on inclusion and exclusion criteria. Subjects will be randomly allocated into two groups using block randomization with allocation concealment ensured through sequentially numbered, sealed opaque envelopes.each goup consist of 34 participants Pre- and post-intervention gait analysis will be performed using smartphone video recording (1920×1080 resolution, 60 fps), mounted on a tripod at hip height and placed 4 meters perpendicular to the midpoint of a 5-meter walkway. Reflective markers will be placed on the greater trochanter, lateral femoral condyle, lateral malleolus, and head of the 5th metatarsal. Videos will be analyzed using Kinovea software (version 0.8.15) to measure knee hyperextension, ankle dorsiflexion, and time to walk 5 meters. Spatiotemporal parameters will be evaluated using the Wisconsin Gait Scale (WGS). An independent assessor blinded to group allocation will conduct all outcome assessments. Both groups will receive 20 sessions of routine physiotherapy over one month (60–90 minutes per session, which inludes stretching,strengthening, gait training and balance training including rest). The experimental group will receive prowling gait training (10–15 minutes) with kinesio taping, focusing on bilateral knee flexion (15–45 degrees) and mild trunk forward flexion during stance, with emphasis on maintaining this pattern during daily activities. Manual assistance will be provided when required. Taping will be reapplied every third day. Post-intervention assessments will be performed using the same tools and methods as the pre-assessment. The primary outcome is the change in degree of knee hyperextension, while secondary outcomes include ankle dorsiflexion, 5-meter walk time, and Wisconsin gait scale.
|
| Comparator Agent |
Mcconnell taping with routine physiotherapy with prowling |
This study involves post-stroke subjects with knee hyperextension. Eligible participants will be screened based on inclusion and exclusion criteria. Subjects will be randomly allocated into two groups using block randomization with allocation concealment ensured through sequentially numbered, sealed opaque envelopes. Pre- and post-intervention gait analysis will be performed using smartphone video recording (1920×1080 resolution, 60 fps), mounted on a tripod at hip height and placed 4 meters perpendicular to the midpoint of a 5-meter walkway. Reflective markers will be placed on the greater trochanter, lateral femoral condyle, lateral malleolus, and head of the 5th metatarsal. Videos will be analyzed using Kinovea software (version 0.8.15) to measure knee hyperextension, ankle dorsiflexion, and time to walk 5 meters. Spatiotemporal parameters will be evaluated using the Wisconsin Gait Scale (WGS). An independent assessor blinded to group allocation will conduct all outcome assessments. Both groups will receive 20 sessions of routine physiotherapy over one month (60–90 minutes per session, which inludes stretching,strengthening, gait training and balance training including rest). The comparator group will receive prowling gait training (10–15 minutes) with Mcconnell taping, focusing on bilateral knee flexion (15–45 degrees) and mild trunk forward flexion during stance, with emphasis on maintaining this pattern during daily activities. Manual assistance will be provided when required. Taping will be reapplied every third day. Post-intervention assessments will be performed using the same tools and methods as the pre-assessment. The primary outcome is the change in degree of knee hyperextension, while secondary outcomes include ankle dorsiflexion, 5-meter walk time, and Wisconsin gait scale. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
BOTH GENDER INCLUDED.
FIRST EPISODE STROKE.
SUBJECT REFERRED BY NEUROLOGIST WITH PRESENCE OF
KNEE HYPEREXTENDED IN POST STROKE.
MONTREALCOGNITIVE ASSESSMENT GREATER THAN 26.
ABILITY TO WALK WITH OR WITHOUT SUPPORT
INCLUDING ASSISTIVE DEVICES.
BRUNNSTROM RECOVERY STAGE OF LOWERLIMB EQUAL TO GREATER THAN STAGE 3. |
|
| ExclusionCriteria |
| Details |
SEVERE MUSCLE CONTRACTURE.
MSK OR CARDIOPULMONARY OR ANY OTHER.
NEUROLOGICAL DEFICITS OTHER THAN STROKE
THAT INFLUENCE PERFORMANCE.
ALLERY TO TAPING.
UNCOOPERATIVE PATIENTS. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bi-dimensional tool kinovea software-dorsiflexion angle and knee hyperextension angle |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is considered to be a leading cause of disability throughout the world.(1) After a stroke, many patients have unilateral sensorimotor deficits, resulting in reduced ambulation ability, with approximately thirty percent unable to walk independently (2) . Even when walking unassisted, hemiparetic gait in post-stroke patients leads to many unique motions and abnormal muscle activities with various joint trajectories (3) . Restoring the ability to walk safely and efficiently is one of the major goals in stroke rehabilitation. There are considerable variations in gait abnormality in patients with stroke, depending on the severity of paresis, spasticity, limited range of motion, impaired proprioception, impaired cognition, and the difference of duration from stroke onset; however, certain typical patterns have been identified. (4-6) Genu recurvatum, or hyperextension of the knee during the stance phase of the gait which extends beyond full knee extension (zero degrees), is common in patients who experience limb paresis that is sufficiently severe to extensively impair walking speed impairs gait efficiency, augments energy expenditure during gait, and may give rise to knee pain, which can further lead to gait asymmetry, thereby affecting the cosmetic appearance. (4,5) Genu recurvatum is defined as hyperextension of the knee of the paretic leg during the stance phase of walking, with or without the use of a walking aid and/or an orthosis. (7) Approximately 65% of stroke subjects are reported to have knee hyperextension. (8) It may result from weakness in the hip extensors, weakness or spasticity in the knee extensors, limited dorsiflexion of the ankle due to spasticity or decreased range of motion, impaired proprioception, or a combination of these factors. (9) okada et.al characterized Knee hyperextension patterns by the strength of knee flexion, trunk motor function, and spasticity of ankle plantarflexors. (10) Longstanding hyperextension may lead to laxity of posterior capsule and anterior cruciate ligament resulting in altered length-tension relationship predisposing to early degenerative changes of knee joint leading to chronic knee pain (11) , poor proprioceptive control of terminal knee extension, knee pain as a result of stress to the ligaments and tendons and reduced independence in daily activities.In addition to the above undesirable effects, knee hyperextension makes knee flexion difficult for adequate ground clearance during the swing phase (12) promoting circumduction and increasing energy consumption while walking. (9,13) Neurophysiological techniques address gait abnormalities; however they do not focus on correction of knee hyperextension. Several interventions have been reported for the treatment of knee hyperextension in post-stroke gait like functional electrostimulation (FES) and electro goniometric feedback, surgical treatment, and orthotic treatment. (9) The evidence available towards robotic devices and brain computer interface in lower limb and gait training is limited. (14) Evidences suggest that the effect of orthotic devices on the paretic lower limb muscle activity is inconclusive and the subjects had concerns with respect to appearance and difficulty with application. (15) Neuromuscular electrical stimulation may lead to muscle fatigue, difficulty in electrode placement, skin irritation and discomfort. (16) In addition to the above, the quadriceps control, specifically eccentric control during loading response, which deserves emphasis due to its crucial role in normal gait, is not addressed in any of the above techniques. Kinesiotaping (KT) is an elastic adhesive tape attached to the surface of the body and is currently used to promote lymphatic circulation, ease pain, provide mechanical support, and improve proprioception. KT has long been used to strengthen weakened muscles, control muscle tone, improve the active range of motion, balance, functional use, and gait ability as a cost effective treatment (17) . It is effective in improving gait ability and muscle function among stroke patients with hemiplegia, KT therapy helps prevent falls and promotes recovery among stroke patients with hemiplegia. The McConnell MT is structurally supportive and uses a tape that is rigid, highly adhesive, and can be worn for up to 18 hours. Based on a previous study finding by Noyes FR, (18) the current study included subjects with stroke who were made to walk with knee flexion and trunk held mild forward flexion, similar to “prowling” i.e. walking in a predatory manner. (19)Walking with bilateral knee bent attitude provides dual advantage by activating quadriceps and changing the direction of moment arm of quadriceps increasing mechanical advantage. (18) It is easily adaptable by the subjects and without the use of any external support devices to reduce knee hyperextension. As there is no strong evidence for rehabiliation of knee hyperextension in post stroke , the purpose of this study was to compare the effectiveness of the prowling with kinesio taping and that of the McConnell therapy with prowling in patients with hyperextended gait in stroke patients by using bi-dimensional tool that is kinovea software to provide quantative data. It is inexpensive 2D technologies available, some of which may match leading high-end reference systems in terms of precision. Kinovea is one such software licensed under GPLv2, created in 2009 via the non-profit collaboration of several researchers, athletes, coaches and programmers from all over the world, it is one such low-cost technology that is free 2D motion analysis software. This tool evaluates the distance, angle, coordinates and spatial temporal parameter. (20) . Wisconsin Gait Scale (WGS) was used as a secondary measure that quantifies gait quality and documents major body part positions during each phase of gait cycle (21–22) . Degree of knee hyperextension, degree of ankle dorsiflexion, time taken to cover 5 m distance.It is a useful tool to rate qualitative gait alterations of post-stroke hemiplegic subjects and to assess changes over time during rehabilitation training. It may be used when a targeted and standardized characterization of hemiplegic gait is needed for tailoring rehabilitation and monitoring results.(22) |