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

NCT06807814 | Completed DMC

• 1 other identifier: REC-UOL-/246/08/24
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Stroke Rehabilitation; Mirror Therapy; Quality of Life (QOL)

Keywords

CONSTRAINT INDUCED MOVEMENT THERPHY; Stroke Rehabilitation; Mirror Therapy; Functional Ambulation; Quality Of Life

Outcome Measures

Primary Outcomes (3)

• Functional Ambulation Categories (FAC)

  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

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

• Tinetti gait and balance score (POMA)

  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.

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

• Short Form Health Survey (SF-12)

  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).

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

Study Arms (2)

Constraint-Induced Movement Therapy (CIMT)

EXPERIMENTAL

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.

Combination Product: Constraint-Induced Movement Therapy (CIMT))

Mirror Therapy

EXPERIMENTAL

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.

Behavioral: Mirror Therapy

Interventions

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)

Constraint-Induced Movement Therapy (CIMT)

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

Mirror Therapy

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 5654590, Pakistan

Location

Related Publications (5)

• Ezendam D, Bongers RM, Jannink MJ. Systematic review of the effectiveness of mirror therapy in upper extremity function. Disabil Rehabil. 2009;31(26):2135-49. doi: 10.3109/09638280902887768.

  PMID: 19903124 BACKGROUND

• Iliyasu Z, Galadanci HS, Danlami KM, Salihu HM, Aliyu MH. Correlates of Postpartum Sexual Activity and Contraceptive Use in Kano, Northern Nigeria. Afr J Reprod Health. 2018 Mar;22(1):103-112. doi: 10.29063/ajrh2018/v22i1.10.

  PMID: 29777647 BACKGROUND

• Feigin VL, Brainin M, Norrving B, Martins S, Sacco RL, Hacke W, Fisher M, Pandian J, Lindsay P. World Stroke Organization (WSO): Global Stroke Fact Sheet 2022. Int J Stroke. 2022 Jan;17(1):18-29. doi: 10.1177/17474930211065917.

  PMID: 34986727 BACKGROUND

• Campbell BCV, De Silva DA, Macleod MR, Coutts SB, Schwamm LH, Davis SM, Donnan GA. Ischaemic stroke. Nat Rev Dis Primers. 2019 Oct 10;5(1):70. doi: 10.1038/s41572-019-0118-8.

  PMID: 31601801 BACKGROUND

• Rubiera M, Aires A, Antonenko K, Lemeret S, Nolte CH, Putaala J, Schnabel RB, Tuladhar AM, Werring DJ, Zeraatkar D, Paciaroni M. European Stroke Organisation (ESO) guideline on screening for subclinical atrial fibrillation after stroke or transient ischaemic attack of undetermined origin. Eur Stroke J. 2022 Sep;7(3):VI. doi: 10.1177/23969873221099478. Epub 2022 Jun 3.

  PMID: 36082257 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy; Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• IQRA Mubeen, MS IN NEUROLOGY

  University of Lahore

  PRINCIPAL INVESTIGATOR

• Asim Rana, MS MSK

  University of Lahore

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blinded assessor was considered to minimize bias in outcome measurements. The assessor was unaware of the intervention group assignment for each participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: student

Model Details: 1. Group A (Constraint-Induced Movement Therapy (CIMT 2. Group B (Mirror Therapy):

Study Record Dates

• First Submitted: January 29, 2025
• First Posted: February 4, 2025
• Study Start: January 26, 2024
• Primary Completion: November 12, 2024
• Study Completion: December 20, 2024
• Last Updated: February 4, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)