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 Snapshot
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- 1. Tardieu’s Scale – for spasticity.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
1. Tardieu’s Scale – for spasticity.
Time Frame: T1-Baseline week 0 | T2-After 2nd week | T3-After 4th week | T4-After 6th week
2. Fugl– Meyr Assessment scale for lower limb motor function [ FMA-LE]
Time Frame: T1-Baseline week 0 | T2-After 2nd week | T3-After 4th week | T4-After 6th week
Secondary Outcomes
- 1. Modified Barthel Index- for activities of daily living.
Investigators
Komalpreet Saini
Lovely Professional University