Segmental Vibrator With NMES on Lower Limb Function in Subacute Stroke

NCT06927206 | Recruiting DMC

• 1 other identifier: REC//24/0219 Arooj Shahzad
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke; Ischemic Stroke

Keywords

Dorsiflexion; FMA; NEMS; Segmental muscle vibrator; Stroke; Spasticity; Vibration

Outcome Measures

Primary Outcomes (5)

• Modified Ashworth Scale (for spasticity)

  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.

  8 weeks

• Fugl-Meyer Assessment (for lower limb function)

  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.

  8 weeks

• 10 Metre Walk Test (mobility)

  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

  8 weeks

• Wisconsin Gait Scale (for gait)

  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.

  8 weeks

• Goniometer for ROM

  A goniometer is a valid clinical tool used to measure the range of motion in joints. It used to measure the ankle dorsiflexion ROM.

  8 weeks

Study Arms (2)

group A

EXPERIMENTAL

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

Other: Experimental Group A: Segmental vibrator only on dorsiflexor

group B

EXPERIMENTAL

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

Other: Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors

Interventions

Experimental Group A: Segmental vibrator only on dorsiflexor 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 A

Experimental Group B: Segmental vibrator + Electrical stimulation on dorsiflexors 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.

group B

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Jinnah Hospital

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke; Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aruba Saeed, PhD

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aruba Saeed, Phd

CONTACT

03344399403; arubasaeedpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: assignment

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: April 10, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: August 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)