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NCT Number: NCT06807814

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Mirror Therapy Nervous System Diseases Quality of Life (QOL) Stroke Rehabilitation Vascular Diseases

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore Teaching Hospital

Lahore, Punjab Province, 5654590, Pakistan

About this study

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:

  • 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).

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants having age between 21 and 70 years old were recruited (e Silva et al., 2017).
  • Both genders included (e Silva et al., 2017).
  • Diagnosed with post chronic hemiplegia ischemic stroke (≥6 months) affecting one side of the body(Danlami & Abdullahi, 2017; Mansfield et al., 2018).
  • Participants having ability to follow verbal and visual instructions(Danlami & Abdullahi, 2017).
  • Participants having no significant cognitive impairment (Minimental state examination score ≥ 17(Danlami & Abdullahi, 2017).
  • Participants having low risk of fall (Tinetti gait and balance score ≥20)(Danlami & Abdullahi, 2017).

Exclusion criteria

  • History of other neurological conditions affecting mobility. (Mansfield et al., 2018).
  • Unstable fracture or other orthopedic conditions affecting gait such as OA, fracture and arthritis (Page et al., 2007).

--Severe cognitive impairment.

  • Participants with severe hemiparesis who are unable to reproduce movements accurately with the affected limb, as this may hinder active participation in the therapy(Danlami & Abdullahi, 2017; Ezendam et al., 2009).
  • Individuals with physical limitations that prevent them from positioning themselves adequately to view their affected limb in the mirror during therapy sessions, as this could compromise the effectiveness of mirror therapy(Danlami & Abdullahi, 2017).

Treatment and study plan

Constraint-Induced Movement Therapy (CIMT))

Combination Product

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)

Mirror Therapy

Behavioral

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. 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

Primary outcomes

  1. Functional Ambulation Categories (FAC)

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

    Functional Ambulation Categories (FAC) is a 6-point functional walking test that provides the quantitative measurement of ambulation ability, which means how much human assistance the patient needs while walking, even with personal dual assistive device

  2. Tinetti gait and balance score (POMA)

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

    Tinetti Balance and Gait Assessment Performance Oriented Mobility Assessment (POMA) is a tool designed to assess the balance and gait status of a person with special reference to the potential for falling (Miodonska et al., 2018).

    . Scores are interpreted to reflect fall risk: Pollock et al. categories the serve self-tested mobility at low risk for participants scoring 25-28 points, moderate risk if scoring 19-24 points and high risk if scoring below 19 points on the scale. Also, patients with a score of below 26 are normally classified as high risk of falling.

  3. Short Form Health Survey (SF-12)

    Time frame: 8 weeks (baseline, fourth week and then at the end of the 8 week)

    The SF-12 scoring system generates two summary measures: th.e fact that the patients' disabilities are measured by the Physical Component Summary (PCS) and the Mental Component Summary (MCS). These scores are normalized based on a mean of 50 and standard deviation of 10 to obatain meaningful numerical values. Higher numbers represent better health related quality and those utilities with values above 50 represent superior health while below 50 represent inferior health. (Sampogna et al., 2019).

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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