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Clinical Trials/CTRI/2025/05/087588
CTRI/2025/05/087588
Not yet recruiting
Not Applicable

Combined Effect of Action Observation and Motor Imagery on Motor Function of Lower Limb Among Patients with Acute Stroke: A Randomized Controlled Trial

Nitte Institute of Physiotherapy1 site in 1 country52 target enrollmentStarted: January 7, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
52
Locations
1
Primary Endpoint
Fugl-Meyer Assessment of Lower Extremity

Overview

Brief Summary

Stroke is a major contributor to adult disability worldwide, often resulting in significant lower limb motor deficits that limit mobility, balance, and independence. While conventional physiotherapy remains the cornerstone of stroke rehabilitation, innovative neurorehabilitation techniques are gaining attention for their ability to promote brain plasticity. Action Observation (AO) and Motor Imagery (MI), two non-invasive, cognitive-based strategies, have independently shown potential to enhance motor recovery. However, limited evidence exists on the combined application of AO and MI in stroke rehabilitation, especially for the lower limbs. This randomized controlled trial investigates the synergistic effect of AO and MI, integrated with standard physiotherapy, on improving lower limb motor function in patients with acute stroke. The study aims to offer a novel, effective, and accessible intervention to accelerate functional recovery and restore independence in stroke survivors

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
45.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with MRI or CT-confirmed acute Anterior Cerebral Artery (ACA) stroke Stroke onset between 7 to 30 days prior to enrollment Presence of lower limb hemiplegia Age between 45 and 80 years Both male and female participants Glasgow Coma Scale (GCS) score of 10 or more out of 15 Montreal Cognitive Assessment (MoCA) score of 18 or higher, indicating stable cognition Brunnstrom Recovery Stage (BRS) between stage 3 and stage 5.

Exclusion Criteria

  • MCA, PCA stroke Co-existing LL musculoskeletal disorders Other neurological or psychiatric disorders severe sensory deficits.

Outcomes

Primary Outcomes

Fugl-Meyer Assessment of Lower Extremity

Time Frame: Fugl-Meyer Assessment – Lower Extremity (FMAL-LE), a reliable performance-based scale to assess sensorimotor impairment post-stroke. Scored 0–2 per item, max score 34. Assessed pre- and post-intervention (at 3 weeks) to evaluate motor recovery.

Secondary Outcomes

  • Montreal Cognitive Assessment-MoCA(MoCA will be used pre intervention as a screening tool to assess cognition & orientation, essential for AOT & MI. It evaluates multiple cognitive domains with high sensitivity, specificity ensuring participants can follow instructions & differentiate imagined versus real actions)

Investigators

Sponsor Class
Other [NITTE Institute of Physiotherapy NITTE (Deemed to be University)]

Study Sites (1)

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