Segmental Vibrator With NMES on Lower Limb Function in Subacute Stroke

NCT ID: NCT06927206

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-10
• Study Completion Date: 2025-09-30

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.

Conditions

Subacute Stroke; Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group A

Group A: Standard physical therapy and segmental vibrator on dorsiflexor muscle groups

Group Type: EXPERIMENTAL

Experimental Group A: Segmental vibrator only on dorsiflexor

Intervention Type: OTHER

Segmental vibrator only on dorsiflexor:

After standard physiotherapy session this group received the intervention of segmental vibration. Tibialis anterior muscle targeted for dorsiflexor. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.

group B

Group B: Standard physical therapy and segmental vibrator + electrical stimulation on dorsiflexor muscle group

Group Type: EXPERIMENTAL

Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors

Intervention Type: OTHER

Segmental vibrator + Electrical stimulation on dorsiflexors:

After standard physiotherapy session this group received the intervention of neuromuscular electrical stimulations by means of EMS. Two electrodes were used for this procedure. Tibialis anterior muscle targeted for dorsiflexor. One pad of electrode was placed on anterior of lower leg just below tibial tuberisty and other was 5cm below to it .With a 250-microsecond pulse duration, the EMS device was set up to provide a biphasic current with a symmetrical waveform at 50 Hz for 15 seconds. It was also tuned for a 3-second ramp up time and a 30-second rest period. Each respondent set the intensity to the highest level they could tolerate. Secondly, segmental vibrator was applied for focal vibrations on tibialis anterior. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.

Interventions

Experimental Group A: Segmental vibrator only on dorsiflexor

Segmental vibrator only on dorsiflexor:

After standard physiotherapy session this group received the intervention of segmental vibration. Tibialis anterior muscle targeted for dorsiflexor. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.

Intervention Type: OTHER

Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors

Segmental vibrator + Electrical stimulation on dorsiflexors:

After standard physiotherapy session this group received the intervention of neuromuscular electrical stimulations by means of EMS. Two electrodes were used for this procedure. Tibialis anterior muscle targeted for dorsiflexor. One pad of electrode was placed on anterior of lower leg just below tibial tuberisty and other was 5cm below to it .With a 250-microsecond pulse duration, the EMS device was set up to provide a biphasic current with a symmetrical waveform at 50 Hz for 15 seconds. It was also tuned for a 3-second ramp up time and a 30-second rest period. Each respondent set the intensity to the highest level they could tolerate. Secondly, segmental vibrator was applied for focal vibrations on tibialis anterior. The segmental vibration of high frequency i.e 100 Hz and low amplitude (0.2-0.5mm) was applied at muscle belly for 10 min while interpersed with a 1 min break by mean of segmental vibrator.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed, PhD

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Jinnah Hospital

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Aruba Saeed, Phd

Role: CONTACT

arubasaeedpt@gmail.com

03344399403

Facility Contacts

Aruba Saeed

Role: primary

arubasaeedpt@gmail.com

344399403

Other Identifiers

REC//24/0219 Arooj Shahzad

Identifier Type: -

Identifier Source: org_study_id