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Trials / Completed

CompletedNCT06807814

COMPERATIVE EFFECTS of CONSTRAINT- INDUCED MOVEMENT THERAPY and MIRROR THERAPY on FUNCTIONAL AMBULATION and QUALITY of LIFE in CHRONIC STROKE PATIENTS

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
56 (actual)
Sponsor
University of Lahore · Academic / Other
Sex
All
Age
21 Years – 70 Years
Healthy volunteers
Not accepted

Summary

Stroke is a global health issue as this happens when the blood flow to the brain is disrupted or reduced, depriving the brain tissue of sugar and oxygen. This interruption affects the brain cells hence leading to the loss of a cell Various physical, cognitive and emotional losses are experienced. Cerebrovascular accident or simply stroke, is the fifth cause of mortality and one of the most common causes of disability in the United States of America (Campbell et al., 2019). There are two main types of stroke: ischemic and hemorrhagic. An ischemic stroke is characterized by an occlusion of a cerebral artery by an embolus or thrombus while hemorrhagic stroke results from a hemorrhage in the brain due to rupture of a blood vessel. A TIA or so-called mini stroke occurs when the clot is not severe enough to result in lasting symptoms (Feigin et al., 2022; Strilciuc et al., 2023). Strokes substantially affect an individual mobility and overall quality of life, although few comparative studies comparing CIMT and MT exist in the literature. This research therefore seeks to systematically compare the effects of these two interventions on functional ambulation and quality of life of chronic stroke patients. Hereby, the research compares structured, task specific CIMT with the less structured, more general approach of MT in order to offer clinicians empirically founded recommendations on what course of action might prove effective for patients. This study also provides new insights to the field given that it not only describes the potential of CIMT within outpatient physiotherapy treatment but also provides an overview of the long-term effects for patients with stroke. These outcomes of this study will be useful in developing rehabilitative research, improving clinical practice protocols, and thereby improve the lifestyles of people living with chronic stroke.

Detailed description

To compare the effects of MT and CIMT on functional ambulation and quality of life in chronic stroke patients. Study Design: This was a randomized controlled trial with two parallel groups: 1. Group A (Constraint-Induced Movement Therapy (CIMT)): A well-defined and structured rehabilitation program that restricts the use of the unaffected limb to promote the functional recovery of the affected limb in chronic stroke patients(Franck et al., 2019). 2. Group B (Mirror Therapy): A specific intervention that uses a mirror to create a visual illusion of the affected limb, with the goal of improving motor function and quality of life in chronic stroke patients * Screening: Patients was screened to meet inclusion criteria. The consent form was taken from patients then patients was randomly allocated into two groups (33 in each group). * Randomization: Patients fulfilling the inclusion criteria will be randomly divided into experimental and control groups using the computer software. * Blinding: The study will be single blinded. The assessor, who has 5 years of experience in both clinical practice and research, will be unaware of the treatment given to both groups and will assess the participants objectively. * Allocation: Allocation of the participants will be concealed, and envelope concealment method will be used for it. * Outcome Measures: * Functional Ambulation Categories (FAC) * Tinetti gait and balance score (POMA) * Short Form Health Survey (SF-12) Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants. Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Conditions

Interventions

TypeNameDescription
COMBINATION_PRODUCTConstraint-Induced Movement Therapy (CIMT))A well-defined and structured rehabilitation program that restricts the use of the unaffected limb to promote the functional recovery of the affected limb in chronic stroke patients(Franck et al., 2019). Sit-to-stand transitions, Indoor overground walking (forward, backward, and sideways), Weight-bearing movements in different directions: Stepping over obstacles and climbing stairs, Ideally, specific tasks to involve the paretic limb according to the activity of stroke survivors. This task was repeated ten times as part of the therapy sessions. Dynamic strengthening exercises like squats and lunges are integrated, progressively increasing intensity as patients gain confidence and strength. Balance and core stability exercises, including single-leg stances and seated weight shifts on therapy balls, address postural control and stability.(Cabanas-Valdés \& Boix-Sala, 2021)
BEHAVIORALMirror TherapyA specific intervention that uses a mirror to create a visual illusion of the affected limb, with the goal of improving motor function and quality of life in chronic stroke patients. The MT protocol included 10 minutes of warm-up, 1 hour of mirror box training, and 50 minutes of functional task practice. The warm-up activities included stretching and passive range of motion exercises. During the mirror box training, a mirror box that reflected the image of the unaffected arm was placed in the participant's midsagittal plane. Participants were required to symmetrically move both hands as simultaneously as possible while watching the reflection of the unaffected arm in the mirror as if it were the affected one. To ensure that the participants focused on the reflection, the unaffected arm was placed in the mirror box, and vision of the affected arm was occluded by a vertical board placed beside the mirror box. The activities consisted of transitive (eg, gross motor tasks, such as reaching

Timeline

Start date
2024-01-26
Primary completion
2024-11-12
Completion
2024-12-20
First posted
2025-02-04
Last updated
2025-02-04

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT06807814. Inclusion in this directory is not an endorsement.

COMPERATIVE EFFECTS of CONSTRAINT- INDUCED MOVEMENT THERAPY and MIRROR THERAPY on FUNCTIONAL AMBULATION and QUALITY of L (NCT06807814) · Clinical Trials Directory