- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06292403
Effects of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy
Effect of Strength Training of Non-paretic Upper and Lower Limb With or Without Mirror Therapy on Motor Function Recovery of the Pareytic Side in Stroke Patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Stroke is defined as rapidly developing clinical signs of focal or global cerebral function disturbance that lasts more than 24 hours or leads to death, with no other apparent cause than that of vascular origin. Hemiplegia shows one side of the body paralysis involving one upper and one lower extremity. The term hemiplegia is often used generically to refer to the wide variety of motor problems that result from stroke.There are several stroke rehabilitation strategies for UL motor impairment including strength training and mirror therapy.
The idea is to re-educate the brain through a simple task, in which the individual performs a series of movements with the healthy arm, which is reflected in the mirror as if it was the injured arm. In this way, the reflex in the mirror of the healthy arm tricks the brain in believing that the injured arm is functioning as it should before the stroke. Isokinetic strengthening may provide motor and functional improvement in paretic upper extremity among patients with post-stroke hemiplegia. This strategy makes use of the brain's adaptability to enhance motor function after a stroke .
Monika Ehrensberger et al (2019) in a study concluded potential effectiveness of mirror-aided cross-education was undertaken and results portray that, in the case of training isometrically, cross-education was not augmented by mirror therapy. (The effectiveness of strength training of the NHS is evidenced in terms of promoting recovery in patients with stroke experiencing balance, mobility, and muscle strength of the paretic side .
Chenlan Shao et al (2022) conducted his study on the effect of strength training of the non-hemiplegic side (NHS) on balance function, mobility, and muscle strength of patients with stroke. He concluded that Strength training of the NHS can promote recovery of balance, mobility, and muscle strength of the paretic side of patients with stroke.
Harris et al demonstrated that leg weakness develops on the non hemiplegic side (NHS) in the first week after acute stroke. This decline in NHS muscle strength must not be ignored in patients with stroke, because it is highly associated with functional performance, and it can be used as an independent predictor of short-term functional gain and outcomes after stroke.
The previous study investigated the feasibility and potential effectiveness of mirror-aided cross-education compared with cross-education alone in post stroke upper limb recovery only. In addition, previous studies, mirror therapy, and contralateral strength training have shown promising results individually, but their direct comparison for both upper and lower limbs remains under-explored in the literature.
The rationale for this study stems from the critical need to understanding the effectiveness of only mirror-therapy performed solely versus mirror-aided treatment coupled with strength training in enhancing motor functionality across both upper and lower limbs can significantly impact rehabilitative protocols.
This research could uncover potential synergies between the two interventions, presenting an opportunity to develop cost effective novel combined approaches that capitalize on their respective strengths. Ultimately, the study's findings have the potential to advance the field of neuroplasticity aided neurorehabilitation and contribute to improved quality of life for individuals dealing with hemiplegia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Aabroo Aabroo, Ms NMPT
- Phone Number: 03155185508
- Email: sara.aabroo@riphah.edu.pk
Study Locations
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Punjab
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Rawalpindi, Punjab, Pakistan
- Fatima Hospital
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Contact:
- Sara Aabroo, NMPT
- Phone Number: 03155185508
- Email: sara.aabroo@riphah.edu.pk
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Contact:
- Farwa Akhtar, NMPT
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Girls aged 17-24 years with regular --Menstrual cycle
- Unmarried girls
Exclusion Criteria:
- Athletes
- Married women
- Girls who were regularly exercising
- Having any pelvic pathology
- Abnormal menstrual cycle.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Strength Training
Non-hemiplegic lower limb stepping forward training Non-hemiplegic upper limb pulling elastic belt in standing position repeatedly Hemiplegic lower limb stepped over an obstacle or climbed a platform The patients will stretch their arms to touch distant objects in a standing position repeatedly.
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training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks.
were allowed to rest for 3-5 min during each training.
|
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Experimental: Mirror Therapy and strength Training Group
Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror.
Participants in the (control group) strength training only group will exercise without a mirror entirely.
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training time will be 30 minutes therapy, once a day, 3 days a week for 8 weeks.
were allowed to rest for 3-5 min during each training.
Participants in the (trial group) mirror and strength training group observed the reflection of the exercising arm and leg in the mirror.
Participants in the (control group) strength training only group will exercise without a mirror entirely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Barthel Index
Time Frame: 8 weeks
|
MBI is a five-level rating scale, including evaluation of bathing, grooming, feeding, dressing, bowels, bladder, toilet, stairs, chair/bed transfers, and walking.
Higher scores represent higher degree of ADL independence.
MBI was an efficient, reliable, and valid assessment of ADL for stroke patients.
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8 weeks
|
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Dynamic Gait Index
Time Frame: 8 weeks
|
Dynamic Gait Index (DGI) is a performance-based tool that quantifies the dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking.
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8 weeks
|
|
Berg Balance Scale
Time Frame: 8 weks
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Consists of 14 tasks and total score of 56.score of 0-20 indicates severe fall risk, 20-45 includes moderate risk of fall and 45-60 illustrates thr functional balances state.
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8 weks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara Aabroo Aabroo, Nmpt, Riphah International University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Farwa Akhtar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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