Google Maps

NCT07718776

Overview

NCT ID: NCT07718776
Lead Sponsor: Riphah International UniversityOTHER
Official Title: Comparative Effects of Synergy-Based Electrical Stimulation Versus Task-Oriented Training on Lower Limb Motor Function in Post-Stroke Patients
Brief Summary: Stroke-induced lower limb impairments severely inhibit functional independence and mobility in survivors. Inventive techniques like Synergy-Based Electrical Stimulation (SBES) and Task-Oriented Training (TOT) support favorable rehabilitation results based on Neuroplasticity. This study aims to compare the effectiveness of these in restoring purposeful movements and enhancing motor functions in post-stroke patients.This study aims to compare the efficacy of (SBES) and Task-Oriented Training (TOT) in improving lower limb motor control in sub-acute post-stroke patients.

This study will be a single-blinded randomized clinical trial design. Participants, aged 40-60 will be recruited in this study by Non-Probability convenience sampling from Rehabilitation centers and Neurology departments. Informed consent and consistent attendance throughout the intervention will be required. Through the computerized table generator method of randomization, participants will be evenly divided into two groups. Both groups will receive conventional therapy, like stretching, strengthening, and isometrics, with modalities. Group A will receive 30 Hz electrical stimulation on the affected lower limb muscles (hip flexors, knee flexors, and ankle dorsiflexors) in a synergic pattern, for 60 minutes, thrice weekly for 6 weeks. Group B will engage in functional tasks for 60 minutes, thrice weekly for 6 weeks, repeated 10 times per set with 2 sets of each activity, plus an additional self-practice session. Outcome measures will be assessed at baseline and post-intervention stages by the Fugl-Meyer Assessment for motor recovery, Time UP and Go Test (TUG) and 10 Meter Walk Test for functional mobility, gait, and balance. The paired sample t-test will be used for within-group analysis in the parametric data and the Wilcoxon test for non-parametric data, whereas, for between-group analysis independent t-test will be used for parametric data and Mann Whitney U test will be used for non-parametric data. Statistical analysis will be done by using SPSS version 26.

Keywords: Lower Limb, motor control, SBES, Strength, Stroke, TOT.

Status and Timeline

Status: Active, not recruiting
Last Update Posted: Jul 22, 2026Actual
Start Date: Jun 5, 2026Actual
Primary Completion Date: Aug 6, 2026Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Age: 40 to 60 years

Both Male and Female participants

In the sub-acute phase of stroke (1-6 months post-stroke) with lower limb motor impairment but with the ability to initiate at least trace muscle contraction (Grade ≥ 1).

Participants must have the ability to understand and follow simple verbal commands with the Mini-Mental State Examination (MMSE) ≥ 26.

Participants must have a first-ever ischemic and hemorrhagic stroke in the sub-acute stage.

Participants who are functionally ambulatory and able to walk a minimum of 10 feet, with or without the use of assistive devices with a Functional Ambulation Category (FAC) score ≥ 2.

Exclusion Criteria:

Participants have severe cognitive impairment and an inability to understand or follow instructions, and severe sensory impairment with profound sensory loss in the lower limb affecting balance or feedback-based training.

Participants having orthopedic limitations like recent fractures, joint deformities, or surgeries affecting the lower limbs.

Participants having implanted electrical devices like pacemakers are contraindicated for electrical stimulation

Participants having a history of more than one stroke episode and or multiple infarcts.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 32Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: No data available
Locations: -

Overview

Status and Timeline

Participation Criteria

Study Plan

Contacts and Locations

Similar Studies