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

NCT07448532 | Recruiting DMC

• 2 other identifiers: DPT/ERB/26U1111-1334-2744
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke (Subacute)

Keywords

Fugl-Meyer Assessment; Functional Independence Measure; Lower limb rehabilitation; Stroke (subacute); Foot Clearance; Neuromuscular Rehabilition; Mirror therapy (MT); Functional Electrical Stimulation (FES)

Outcome Measures

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

  From the enrollment to the end of treatment at 4 weeks

Secondary Outcomes (1)

• Activity of Daily Living (ADLs)

  From the enrollment to the end of treatment at 4 weeks

Study Arms (2)

Group A (Functional Electrical Stimulation and Routine Physical Therapy)

EXPERIMENTAL

Functional Electrical Stimulation (FES) in combination with Routine Physical Therapy. The interventions will be administered three times per week over a four-week period. Each session will last 50 minutes. Functional Electrical Stimulation will be applied to the affected lower limb, primarily targeting muscles responsible for ankle dorsiflexion, to facilitate improved foot clearance during gait. In addition to FES, participants will undergo Routine Physical Therapy consisting of stretching exercises, strengthening exercises, and repeated task-oriented gait training aimed at improving functional ambulation. Routine Physical Therapy will be provided for 20 minutes per session, while FES will be applied for 30 minutes, making a total session duration of 50 minutes. This arm aims to assess the effects of neuromodulation through peripheral electrical stimulation on foot clearance and gait performance in sub-acute stroke patients.

Other: Neuromodulators

Group B (Mirror Therapy and Routine Physical Therapy)

ACTIVE COMPARATOR

Group B will receive Mirror Therapy in combination with Routine Physical Therapy. The interventions will be administered three times per week over a four-week period, with each session lasting 50 minutes. Mirror Therapy will involve participants performing movements of the unaffected lower limb while observing its reflection in a mirror placed in the sagittal plane, creating the illusion that the affected limb is moving normally. This intervention is intended to enhance sensory feedback and promote motor recovery through visual input. Alongside Mirror Therapy, participants will receive Routine Physical Therapy consisting of stretching, strengthening exercises, and repeated task-oriented gait training. Routine Physical Therapy will be provided for 20 minutes, while Mirror Therapy will be conducted for 30 minutes per session, resulting in a total treatment duration of 50 minutes. This arm aims to evaluate the effects of sensory augmentation through visual feedback on foot clearance and

Other: Sensory Agumentation

Interventions

Neuromodulators OTHER

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.

Also known as: Functional Electrical Stimulation (FES)

Group A (Functional Electrical Stimulation and Routine Physical Therapy)

Sensory Agumentation OTHER

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

Also known as: Mirror Therapy

Group B (Mirror Therapy and Routine Physical Therapy)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients who received more 24 scores on Mini Mental State Exam and could comprehend and follow the information researcher provides.
• No orthopedic diseases in upper and lower extremities.
• Patients with functional ambulation classification (FAC) score of 3 or 4 were included (FAC is a scale of 0-5, where 3 indicates supervision or standby guarding and 4 indicates independent on level surfaces.
• Patients with inadequate ankle dorsiflexion during the swing phase of gait.
• Patients with adequate minimal stability at the ankle during stance with stimulation.

You may not qualify if:

• 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.
• We excluded patients with pregnancy, plantar flexion contracture, and severe hemi-neglect.
• Subjects with hip or knee prostheses made of metal on the lower limb were excluded.

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (2)

Lahore University of Biological and Applied Sciences

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Lahore University of Biological and Applied Sciences

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Neurotransmitter Agents; Mirror Movement Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Nabeela Dawood

  Lahore University of Biological and Applied Sciences

  STUDY CHAIR

• Rohma Shah

  Lahore College of Physical Therapy

  PRINCIPAL INVESTIGATOR

• Ayesha Hassan

  Lahore College of Physical Therapy

  PRINCIPAL INVESTIGATOR

• Rabiya Haroon

  Lahore College of Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabeela Dawood

CONTACT

+923315337445; nabeela.dawood@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will use a single-blind design, where the participants will be unaware of the specific intervention group they have been assigned to (i.e., whether they are receiving the combination of sensory augmentation and neuromodulation, sensory augmentation alone, or neuromodulation alone). This masking ensures that participant expectations do not influence their responses to the interventions. However, the treating therapists and study coordinators who administer the interventions and assess outcomes will not be masked, as they will be responsible for the direct management of the interventions and data collection. This design allows for an objective evaluation of the effects of the interventions while minimizing potential biases from participant expectations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Nabeela Dawood

Model Details: Not Needed

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: January 22, 2026
• Primary Completion: June 22, 2026
• Study Completion: June 27, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: June 2026- October 2026

Locations

PA (2)