Vibration plus electrical stimulation to improve ankle lifting after subacute ischemic stroke
Combined Effects of Segmental Vibrator With Neuromuscular Electrical Stimulation for Dorsiflexors on Lower Limb Function in Subacute Stroke
This test tries a small segmental vibrator alone or together with electrical muscle stimulation on the ankle to help people aged 45–60 who are 15 days to 12 weeks after an ischemic stroke improve foot lifting and walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | All |
| Sponsor | Riphah International University Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT06927206 on ClinicalTrials.gov |
What this trial studies
This interventional, single-center study enrolls subacute ischemic stroke patients and applies focal vibration to the ankle dorsiflexors either alone or combined with neuromuscular electrical stimulation (NMES). Participants are assigned to one of two intervention groups: segmental vibrator only or segmental vibrator plus electrical stimulation, with treatment sessions delivered in-person. Outcomes focus on ankle dorsiflexion, lower-limb motor function (including measures such as Fugl-Meyer scores), and related mobility measures over the treatment and follow-up period. The trial targets adults 45–60 years old who are 15 days to 12 weeks post-ischemic stroke and meet cognitive and spasticity eligibility criteria and is conducted at Jinnah Hospital in Lahore.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45–60 with a confirmed ischemic stroke 15 days to 12 weeks earlier, MoCA 18–24, NIHSS 1–15, Modified Ashworth < +1, who feel no pain from the vibrator and can provide informed consent (or have a legal representative).
Not a fit: Patients with severe spasticity or other major neurological/orthopedic conditions, significant cognitive impairment, painful response to vibration, hemorrhagic stroke, or those outside the specified age or post-stroke time window are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve ankle dorsiflexion, reduce foot drop, and make walking and daily activities easier for people recovering from subacute ischemic stroke.
How similar studies have performed: Previous small trials of focal vibration or of NMES separately have shown modest improvements in limb function after stroke, but combining focal vibration with NMES for ankle dorsiflexors is relatively new and not widely tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lahore, Punjab Province
- Jinnah Hospital — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Aruba Saeed, PhD — Riphah International University
- Study coordinator: Aruba Saeed, Phd
- Email: arubasaeedpt@gmail.com
- Phone: 03344399403
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.