Segmental Vibrator With NMES on Lower Limb Function in Subacute Stroke

Not Applicable

Not yet recruiting

• Conditions: Subacute Stroke; Ischemic Stroke

• Registration Number: NCT06927206
• Lead Sponsor: Riphah International University

Brief Summary

Stroke is one of the world's leading causes of death and disability. It can cause a variety of motor disorders, such as apraxia, sensory deficits, abnormal muscle tone, inadequate weight transfer, lack of fine motor skills, incoordination, and balance deficit. These disorders can have a significant negative impact on a person's quality of life.

Detailed Description

The definition of a stroke, as given by the World Health Organization (WHO), is a clinical illness that includes focused disruptions in cerebral functioning that develop quickly and have a vascular origin. Cerebrovascular accidents, or strokes, rank third in the world in terms of disability and are the second major cause of mortality. A stroke is a major cause of dementia and depression. A stroke is the abrupt death of some brain cells from a lack of oxygen when blood supply to the brain is interrupted by an artery rupturing or blocking the brain. Across the world, low- and middle-income nations account for 70% of stroke cases and 87% of stroke-related fatalities as well as disability-adjusted life years. Patients who have had a stroke often experience a variety of motor disorders, such as dysphagia and dysarthria, imbalance issues, apraxia, sensory deficiencies, abnormal muscle tone, abnormal motor pattern, inadequate weight transfer, lack of fine motor skills, and muscle weakness. After completing their rehabilitation, 50% to 60% of stroke patients still have some degree of motor impairments, and at least 50% of these patients depend on their daily activities. Muscle paresis and spasticity are two of the most prevalent stroke disabilities.

This study aims to explore the effects of combining focal vibration (FV) with electrical neuromuscular stimulation (NMES) on the ankle dorsiflexors in subacute stroke patients. These techniques are relatively new in neurorehabilitation and have shown promise in reducing muscle stiffness and enhancing movement compared to traditional physiotherapy methods. By focusing on the lower limb issues commonly seen after a stroke, we seek to understand how this combination therapy can improve motor function in these patients. The findings of this study could help in developing more effective treatment strategies for stroke survivors dealing with lower limb dysfunction.

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-07
• Study Start: 2025-04-10
• Study First Submitted QC: 2025-04-14
• Last Update Submitted: 2025-04-14
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Both male and female patients were included in the study.
• The age range of participants was between 45 and 60 years.
• Participants that were diagnosed with ischemic stroke patient.
• Participants had experienced sub-acute ischemic stroke, specifically 15 days to 12 weeks post-stroke.
• Montreal Cognitive Assessment scores falling within the range of 18-24 were necessary.
• Modified Ashworth scale scores had to be less than +1
• National Institutes of Health Stroke Scale (NIHSS) score falling within the range of 1 to 15 were necessary.
• Participants feel no pain from the vibrator.
• It was anticipated that participants would either be able to give informed consent or have a legal representative who could do so.

Exclusion Criteria

• People who had a history of serious neurological or mental conditions that would have impeded lower limb motor recovery-aside from stroke-were not included.
• Individuals with severe arthritis or joint injuries, among other illnesses that would have interfered with treatment or evaluations, were not allowed to participate.
• Individuals who had significant hearing or vision impairments that would have hampered treatment or evaluations were not included.
• Individuals undergoing anti-spatial therapy or other clinical trials, those with bilateral brain lesions, and those with ischemic involvement of the cerebellum or basal ganglia were not allowed to participate.
• Participants having metal implants e. g cardiac pacemaker and skin lesion at the site of stimulation electrodes were excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Goniometer for ROM	8 weeks	A goniometer is a valid clinical tool used to measure the range of motion in joints. It used to measure the ankle dorsiflexion ROM.
Modified Ashworth Scale (for spasticity)	8 weeks	The Modified Ashworth Scale (MAS) is a revised version of the original Ashworth Scale that measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone. MAS assigns a grade of spasticity from a 0-4 ordinal scale.
Fugl-Meyer Assessment (for lower limb function)	8 weeks	Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. The scale is comprised of five domains and there are 155 items in total: * Motor functioning (in the upper and lower extremities); * Sensory functioning (evaluates light touch on two surfaces of the arm and leg, and position sense for 8 joints); * Balance (contains 7 tests, 3 seated and 4 standing); * Joint range of motion (8 joints); * Joint pain Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. The total possible scale score is 226.
10 Metre Walk Test (mobility)	8 weeks	The 10-Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. Gait speed is calculated by dividing the total distance to time
Wisconsin Gait Scale (for gait)	8 weeks	Wisconsin Gait Scale (WGS) is an observational tool for the evaluation of gait quality in individuals after stroke with hemiplegia. It is divided into four subscales, which assess a total of fourteen spatiotemporal and kinematic parameters of gait observed during the consecutive gait phases.