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Search / Trial NCT06927206

Segmental Vibrator With NMES on Lower Limb Function in Subacute Stroke

Launched by RIPHAH INTERNATIONAL UNIVERSITY · Apr 14, 2025

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Dorsiflexion, Fma, Nems, Segmental Muscle Vibrator, Stroke, Spasticity, Vibration.

ClinConnect Summary

This clinical trial is looking at how a special device, which vibrates and sends electrical signals to the muscles, can help improve movement in people who have had a stroke. Specifically, it focuses on patients who have experienced a subacute ischemic stroke, which means they are between 15 days and 12 weeks post-stroke. The goal is to see if this treatment can help patients regain better control and function of their lower limbs, which can be greatly affected after a stroke.

To join the trial, participants need to be between 45 and 60 years old and have been diagnosed with an ischemic stroke. They should have certain cognitive and motor skills within specific ranges, and they must be able to tolerate the vibration from the device without pain. However, people with significant other health issues, severe arthritis, or certain neurological conditions will not be eligible. The trial is not yet recruiting participants, but when it does, those who join can expect to work with healthcare professionals who will guide them through the process and monitor their progress during the treatment.

Gender

ALL

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.

About Riphah International University

Riphah International University is a leading educational institution based in Pakistan, dedicated to advancing healthcare and medical research through innovative clinical trials. With a commitment to excellence in research and education, Riphah emphasizes ethical standards and scientific integrity in its clinical studies. The university collaborates with various stakeholders, including healthcare professionals and industry partners, to enhance patient outcomes and contribute to the global body of medical knowledge. Through its robust research programs, Riphah International University aims to foster a culture of inquiry and improve healthcare delivery both locally and internationally.

Locations

Patients applied

0 patients applied

Trial Officials

Aruba Saeed, PhD

Principal Investigator

Riphah International University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported