Comparative Effects of Functional Electrical Stimulation and Mirror Therapy for Foot Clearance Among Patients With Sub-acute Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorLahore University of Biological and Applied Sciences

About this trial

This study aims to evaluate the effectiveness of two rehabilitation techniques- Functional Electrical Stimulation (FES) and Mirror Therapy (MT)-in improving motor recovery among stroke survivors. Stroke often results in long-term impairments, particularly in foot clearance, which is critical for daily activities. Although current rehabilitation strategies help, more effective solutions are needed to enhance recovery. Participants, aged 18- 85 years old with subacute stroke and foot clearance impairments, will be randomized into two groups: Group A will receive functional electrical stimulation (FES) with routine physical therapy; and Group B will receive mirror therapy (MT) with routine physical therapy. The interventions will take place three times a week for 4 weeks, and participants will undergo motor function assessments, including the Fugl-Meyer Assessment and Functional Independence Measure, before and after the intervention. The study will compare the effects of each intervention on motor recovery, specifically focusing on tibialis anterior function and motor control. The findings could lead to improved rehabilitation protocols, offering stroke survivors better therapeutic options and enhancing their quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged 18-85 years of age, who experienced stroke within ≤6 months.

The Fugl-Meyer motor assessment of lower extremity (FMA-LE) was conducted by physiotherapist in the hospital, and score required to be ≥ 20 points.

Participants possessed healthy nerves, neuromuscular junctions, muscles tissues, and a sufficient range of motion in dorsiflexor and plantarflexion.

The subjects could walk independently on a treadmill for at least 2 min without without experiencing adverse reaction to FES.

Disqualifiers

Patients with cardiac pacemaker, those with skin lesions, who could not be treated due to spasticity within the last three months, and vestibular and cerebellar lesions or deaf- blindness were excluded.

Patients with past or current epilepsy, uncontrolled seizure disorder, mental disorders and all neurological disorders except stroke.

Patients with severe edema of lower extremities or patients of vascular disorders like deep vein thrombosis or thromboembolisms and severe atheroscelerosis of lower extremities.

Subjects with any musculoskeletal dysfunction that would potentially affect gait and causes risk of falls.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neuromodulators

    Other intervention

    Functional Electrical Stimulation was administered to participants in the experimental group to facilitate activation of the ankle dorsiflexor muscles, primarily the tibialis anterior, to improve impaired foot clearance in sub-acute stroke patients. Surface electrodes were placed over the tibialis anterior muscle of the affected limb to elicit ankle dorsiflexion. Electrical stimulation was delivered at an intensity sufficient to produce visible and functional ankle dorsiflexion without causing discomfort. The stimulation aimed to enhance neuromuscular recruitment, improve voluntary motor control, and promote motor relearning through repeated activation of the weakened muscles during functional tasks. Each FES session lasted 30 minutes, followed by 20 minutes of routine physical.

  • Sensory Agumentation

    Other intervention

    Mirror Therapy was administered to participants in the comparison group as a sensory augmentation intervention to enhance motor recovery through visual feedback. A vertical mirror was placed between the lower limbs in the sagittal plane, such that the reflection of the non-paretic limb was visible while the paretic limb was concealed from view. Participants were instructed to perform repeated ankle dorsiflexion and plantarflexion movements with the non-paretic limb while observing its reflection in the mirror. This created the visual illusion that the paretic limb was moving normally, providing visual feedback to the brain. Mirror Therapy aims to stimulate mirror neuron systems and sensorimotor cortical areas, encouraging cortical reorganization and improved motor control of the affected limb. During the session, the paretic limb remained relaxed while the participant focused on the mirror image. Each Mirror Therapy session lasted 30 minutes, followed by 20 minutes of routine physical

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Group A (Functional Electrical Stimulation and Routine Physical Therapy)Experimental treatment 1 intervention
Group B: Group B (Mirror Therapy and Routine Physical Therapy)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Foot Clearance

Sub-acute stroke survivors present with hemi-paretic gait often presents with reduced hip, knee, and ankle flexion during swing phase along with decreased joint motion and power in late stance and pre-swing phase. These impairments result in making foot clearance more difficult. A crucial walking measure that signals tripping is minimum foot clearance (MFC), which takes place in the mid-swing phase of the gait cycle in our study we intend to improve foot clearance in subacute stroke survivors primarily. The tool used for this purpose is Fugl-Meyer Assessment (FMA) a comprehensive, standardized tool used to assess motor function recovery in stroke patients, focusing on the lower limb, balance, and sensory function. The outcomes that were studied in stroke patients are foot clearance and improvement in ADLs. This tool is stroke-specific, performance-based scale designed to evaluate motor recovery, with the Lower Extremity subscale assessing hip, knee, and ankle function, including ankle

Time frame
From the enrollment to the end of treatment at 4 weeks

Secondary outcomes

1

Activity of Daily Living (ADLs)

Stroke survivors need some assistance or are fully dependent on their caregivers for activities of daily living (ADLs). Reduced stroke hospitalization and efficiency-driven care increase the need for early prognosis of basic ADL outcomes (e.g., dressing, mobility, bathing) to optimize early stroke management. Our secondary outcome is improvement in ADLs for which we have used Functional Independence Measure (FIM) is one of the most widely used outcome measures in stroke rehabilitation. The Motor-FIM, which includes items related to transfers, locomotion, and stair climbing, is particularly relevant to mobility outcomes. The FIM demonstrates excellent internal consistency, with Cronbach's alpha values reported between 0.93 and 0.95 for the total scale, and approximately 0.95 for the motor subscale. These findings confirm that the FIM is a reliable and valid instrument for assessing functional independence in ADLs and mobility performance among stroke patients.

Time frame
From the enrollment to the end of treatment at 4 weeks

Other outcomes

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