CONSTRAINT-INDUCED MOVEMENT THERAPY (CIMT) VS. MIRROR THERAPY (MT) ON HAND FUNCTION AND SPASTICITY IN PATIENTS WITH HEMIPARESIS

NCT06910904 | Completed DMC

• 1 other identifier: Rec-UOL-/495/08/24
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to compare the effects of Constraint-Induced Movement Therapy (CIMT) and Mirror Therapy (MT) on hand function and spasticity in individuals with hemiparesis. A total of 68 participants diagnosed with hemiparesis due to stroke or traumatic brain injury were recruited and randomly assigned to two equal groups. Group A received CIMT, while Group B underwent Mirror Therapy. Both interventions were administered over an 8-week period in a controlled rehabilitation setting. Functional assessments were conducted using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) to evaluate motor function and the Modified Ashworth Scale (MAS) to measure spasticity. Data collection occurred at baseline, the 4th week, and the 8th week of the intervention. Descriptive statistics were used to summarize demographic characteristics and baseline measurements, while inferential statistics, including repeated-measures ANOVA and independent t-tests, were applied to assess within- and between-group changes over time. The study also ensured assumptions of normality and sphericity were met to validate the statistical analyses. Demographic data such as age, gender, diagnosis type, and education level were also recorded to understand group comparability and potential influences on therapy outcomes. This study adds to the growing body of literature on non-invasive, evidence-based rehabilitation strategies for upper limb recovery.

Conditions

Stroke; Hemiparesis; Hemiparesis After Stroke

Keywords

Constraint-Induced Movement Therapy; Fugl-Meyer Assessment; Hemiparesis; Mirror Therapy; Spasticity

Outcome Measures

Primary Outcomes (1)

• Motor impairment and and joint functioning

  Assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), which measures motor function, coordination, and reflex activity in the affected limb to evaluate improvements in voluntary movement.

  Baseline, Week 4, and Week 8

Secondary Outcomes (1)

• Spasticity

  Baseline, Week 4, and Week 8

Study Arms (2)

Constraint-Induced Movement Therapy (CIMT)

EXPERIMENTAL

CIMT is a intensive training sessions of 6 hours/day for 5 weeks, focusing on functional tasks with the paretic arm while constraining the unaffected arm using a mitt or sling. Implement a constraint on the non-paretic arm to encourage increased use of the affected arm in daily activities.

Combination Product: Constraint-Induced Movement Therapy (CIMT)

Mirror Therapy (MT)

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. In mirror therapy, the patient is asked to move the unaffected limb while watching the moving limb being reflected in the mirror.

Combination Product: Mirror Therapy (MT)

Interventions

Constraint-Induced Movement Therapy (CIMT) COMBINATION_PRODUCT

CIMT is a intensive training sessions of 6 hours/day for 5 weeks, focusing on functional tasks with the paretic arm while constraining the unaffected arm using a mitt or sling. Implement a constraint on the non-paretic arm to encourage increased use of the affected arm in daily activities. Use shaping techniques to gradually increase the complexity and difficulty of tasks performed with the affected arm (Rahman, 2016). Most commonly, the protocol continues to be 2 weeks in duration but the intensity is adjusted such that the restraint is worn for approximately 6 h per day and therapy is administered for 2 to 3 h per day (MacKenzie \& Viana, 2024). But this study implementing a 2 hour CIMT protocol with 6h restrain for 8 weeks in sub-acute stroke rehabilitation balances therapeutic intensity with practical considerations, potentially enhancing patient engagement and rehabilitation outcomes within clinical settings (Chen et al., 2014; Udoeyop, 2017).

Constraint-Induced Movement Therapy (CIMT)

Mirror Therapy (MT) COMBINATION_PRODUCT

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. In mirror therapy, the patient is asked to move the unaffected limb while watching the moving limb being reflected in the mirror. The congruent visual feedback through the mirror affects brain lesions and motor-related areas on the affected side, facilitating motor recovery. Patients with chronic stroke who can benefit from visual feedback to enhance motor recovery (Gandhi et al., 2020; Rothgangel \& Braun, 2013). Mirror therapy sessions should last at least 10 minutes daily, with the option to increase up to 30 minutes for optimal benefits. Practice mirror therapy exercises at least once a day. Perform gentle movements with the intact limb while observing its reflection in the mirror(Crosby et al., 2016).

Mirror Therapy (MT)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants having age (between 40 and 65 years old) will be recruited.
• Both gender were included (e Silva et al., 2017).
• Participants having ability to follow verbal and visual instructions (Danlami \& Abdullahi, 2017).
• Patient having hemiparesis from 14 to 90 days (Bastola et al., 2021).
• Patients with mild to moderate spasticity (Burnstrom stage 2) (Jan et al., 2019).
• Patients experiencing functional limitations in hand motor function (Gracies et al., 2019).

You may not qualify if:

• History of other neurological conditions (Mansfield et al., 2018).
• Unstable fracture or other orthopedic conditions (Page et al., 2007).
• 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).
• History of shoulder instability or major orthopedic surgery in the affected arm (Gracies et al., 2019).

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

The University of Lahore Teaching Hospital

Lahore, Punjab Province, 54590, Pakistan

Location

Related Publications (1)

• Chen YP, Pope S, Tyler D, Warren GL. Effectiveness of constraint-induced movement therapy on upper-extremity function in children with cerebral palsy: a systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2014 Oct;28(10):939-53. doi: 10.1177/0269215514544982. Epub 2014 Aug 14.

  PMID: 25125440 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis; Muscle Spasticity

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; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this study, a single-blind design was implemented where the outcome assessors were masked to group allocation to reduce assessment bias. Participants and therapists delivering the interventions were not masked due to the nature of the therapies, which required active participation and visible techniques. Data analysts were also blinded to group identities during statistical processing to maintain objectivity. No additional parties beyond assessors and analysts were involved in masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student

Model Details: This study employed a randomized, two-arm parallel interventional design to compare the effects of Constraint-Induced Movement Therapy (CIMT) and Mirror Therapy (MT) in patients with hemiparesis. Participants were randomly assigned to receive either CIMT or MT over an 8-week period, following standardized treatment protocols. Assessments were conducted at baseline, mid-point, and post-intervention using the Fugl-Meyer Assessment (FMA-UE) and Modified Ashworth Scale (MAS). The parallel group model ensured unbiased comparisons between the interventions, reflecting a practical clinical setting. This approach allowed for independent evaluation of each therapy's effectiveness on motor function and spasticity.

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 4, 2025
• Study Start: September 15, 2024
• Primary Completion: March 19, 2025
• Study Completion: March 28, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Locations

PA (1)