| CTRI Number |
CTRI/2024/09/073281 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
29/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which works better for Stroke Recovery: Imagined Movements with Taping or Traditional exercises for stiff Muscles in the Legs? |
|
Scientific Title of Study
|
Effectiveness of Motor Imagery Based Rehabilitation with Kinesio Taping versus Motor Imagery with Conventional Rehabilitation Training in Lower Limb Spasticity in Post Stroke Patients: A Pilot Randomized Clinical Trial |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Komalpreet Saini |
| Designation |
MPT Student |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of Allied Medical Sciences ,Lovely Professional University , Phagwara , Punjab 144411,India
Kapurthala
PUNJAB
144411
India |
| Phone |
7901891120 |
| Fax |
|
| Email |
komalsaini2406@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetanjali Saggar |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of Allied Medical Sciences ,Lovely Professional University , Phagwara , Punjab 144411,India
Kapurthala
PUNJAB
144411
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
geetanjalisaggar11@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetanjali Saggar |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Department of Physiotherapy, Block-3 Room No-105 ,School of Allied Medical Sciences ,Lovely Professional University , Phagwara , Punjab 144411,India
Kapurthala
PUNJAB
144411
India |
| Phone |
8427509407 |
| Fax |
|
| Email |
geetanjalisaggar11@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Phagwara ,Punjab, 144411,India |
|
|
Primary Sponsor
|
| Name |
Dr Geetanjali Saggar |
| Address |
Department of Physiotherapy, Block 3- Room no -105,School of Allied Medical Sciences, Lovely Professional University , Phagwara , Punjab , 144411,India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geetanjali Saggar |
Gurjot Spinal Rehab & Physiotherapy |
SCO 100, opposite - Indian oil petrol pump , Phase 2 , Urban Estate, Jalandhar, Punjab, 144022 ,India
Jalandhar
PUNJAB |
8427509407
geetanjalisaggar11@gmail.com |
| Dr Geetanjali Saggar |
Lovely Professional University |
Department of Physiotherapy, Block 3 -105 ,School of Allied Medical Sciences , Lovely Professional University , Phagwara, 144411,India
Kapurthala
PUNJAB |
8427509407
geetanjalisaggar11@gmail.com |
| Dr Geetanjali Saggar |
Shrimann Superspeciality Hospital ,Jalandhar |
Jalandhar - Pathankot Road Near Reru, Chownk, Jalandhar, Punjab 144012,India
Jalandhar
PUNJAB |
8427509407
geetanjalisaggar11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Lovely Professional University (IEC-LPU) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Motor Imagery with Conventional Rehabilitation |
Motor imagery, also known as motor representation or mental practice, involves mentally visualizing and simulating the performance of a specific motor action without actually doing the movement. This cognitive strategy activates the neural networks responsible for motor planning and execution, even though the physical movement is not carried out. Neuroscientific research supports the concept of motor imagery and has shown that mental practice can improve motor performance and skill acquisition.
Conventional exercises: refer to a wide range of physical activities and workout routines that have been traditionally used to improve and maintain overall fitness, strength, flexibility,
and cardiovascular health. These exercises often involve the use of bodyweight, free weights, resistance bands, or exercise machines and are designed to target specific muscle groups or engage multiple muscle groups simultaneously. Common conventional exercises for stroke rehabilitation include a range of motion exercises, Proprioceptive Neuromuscular Facilitation, strengthening, and weight-bearing exercises. In conventional rehabilitation, the patient will be treated with therapeutic exercises as
stretching exercises of hamstrings, gastrocnemius, Achilles, quadriceps ( 7 repetitions of each with 20 -30 seconds hold ) and
Strengthening exercises include Hip Flexion in a sitting position, sit-to-stand, single leg standing for 10 seconds, for 7 times in a set, lower limb Proprioceptive Neuromuscular Facilitation-10 repetitions of each set with 20 seconds hold, weight-bearing
activities including stepping on the affected leg in standing, and shifting weight on both legs one by one for 10 seconds with 20 repetitions each.
The treatment will be continued for 40 minutes in a Conventional Rehabilitation session, after the 20 minutes of Motor Imagery training, 4 days a week for 6 weeks. |
| Intervention |
Motor Imagery with kinesio Taping |
Motor imagery, also known as motor representation or mental practice, involves mentally visualizing and simulating the performance of a specific motor action without actually doing the movement. This cognitive strategy activates the neural networks responsible for motor planning and execution, even though the physical movement is not carried out. Neuroscientific research supports the concept of motor imagery and has shown that mental practice can improve motor performance and skill acquisition without actually performing the movement.
Kinesio taping is widely used in rehabilitation. This technique involves applying highly elastic tape to the skin of the affected body part to reduce mechanical constraints while providing additional support. It is believed to facilitate treatment outcomes by promoting lymphatic circulation, reducing pain, providing mechanical support, and improving proprioception. Because the tape is thinner and more elastic than conventional tape, it is believed to reduce physical restraint and allow for greater mobility.
Patients will participate in Motor Imagery Training (MIT). First, the patient will relax and practice deep breathing for three minutes. Then a video will be shown of specific lower limb movements and the patient has to spend fifteen minutes mentally visualizing specific lower limb movements shown in the video. These include hip and knee flexion and extension, ankle dorsiflexion and plantarflexion, turning over and sitting on the edge of the bed, transfer from sitting to standing position, standing up for 10 seconds from sitting, lifting the paralyzed leg hold for 5 seconds, relaxing the whole body and walking on a flat surface. They will also visualize stepping up and down stairs. The patient is asked to envision doing these movements 5-6 repetitions per set, with a 30-second rest period after each activity. The session concludes with two minutes of deep breathing to help them re-center. The duration of MIT is 15 minutes, 4 days a week, for 6 weeks. To aid movement after the MIT session of 15 minutes, Kinesio tape will be applied to the anterior tibialis muscles to improve ankle dorsiflexion, the gastrocnemius muscle, and Achilles tendon to inhibit plantarflexion, the rectus femoris to improve knee extension, and the hamstrings to inhibit knee flexion. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
The study will involve patients aged 40-65 who are experiencing physical impairments following an ischemic or hemorrhagic stroke. These patients will have confirmed brain lesions visible on CT or MRI scans. Patients should be in stages II-IV of lower limb motor function, as classified by the Brunnstrom stage classification for hemiplegia, a Grade 2 rating on the Tardieu scale for spasticity. For Motor Imagery Training (MIT), patients must meet several criteria: they need to have a score above 26 on the Mini-Mental State Examination (MMSE), and a score of 25 or higher on the kinesthetic and visual imagery questionnaire. |
|
| ExclusionCriteria |
| Details |
Patients with acute stroke, patients with other neurological issues example Parkinson’s Disease, Multiple Sclerosis, Myasthenia gravis, etc patients with a skin allergy or intolerance to tape, lack of sensation or hypersensitivity, skin lesions or swelling, any psychiatric issues, any serious injury/disease or fracture in the lower extremity bone, or joint deep venous thrombus of the lower extremity.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Tardieu’s Scale – for spasticity.
2. Fugl– Meyr Assessment scale for lower limb motor function [ FMA-LE] |
T1-Baseline week 0
T2-After 2nd week
T3-After 4th week
T4-After 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Modified Barthel Index- for activities of daily living.
|
T1-Baseline week 0
T2-After 2nd week
T3-After 4th week
T4-After 6th week |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2024 |
| 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="0"
Months="6"
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
|
This randomized clinical trial aims to compare the effectiveness of Motor Imagery (MI) combined with Kinesio Taping (KT) versus Motor Imagery with Conventional Rehabilitation (CR) in treating lower limb spasticity in post-stroke patients. The study will involve 30 chronic stroke patients, divided into two equal groups with 15 participants in each group: Group I will receive MI combined with KT, while Group II will receive MI with CR. The participants, aged 40-65, will be selected based on specific inclusion criteria, including verified lesions on CT or MRI, spasticity in the lower limb, and the ability to participate in MI training. Exclusion criteria include acute stroke, other neurological disorders, skin issues, psychiatric problems, and severe lower limb injuries. The treatment will last for six weeks, with patients in Group I receiving 20 minutes of MI followed by KT application, while those in Group II will receive 20 minutes of MI followed by 40 minutes of CR, 4 times a week The effectiveness of the interventions will be assessed using the Tardieu Scale, Fugl-Meyer Assessment (Lower Extremity), Modified Barthel Index, and Brunnstrom Stage of Stroke Recovery. The data collected will be statistically analyzed using IBM SPSS version 22. The findings from this study aim to establish a clinically effective protocol for improving spasticity management and enhancing recovery in post-stroke patients |