NCT07090187Not yet recruiting
Novel Assistive Device and Functional Electrical Stimulation Therapy
Early Rehabilitation of Post Stroke Lower Limb Weakness Using Novel Assistive Device and Functional Electrical Stimulation Therapy
Source: ClinicalTrials.gov · Last updated 29 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Stroke causes neurological deficits, impacting walking, balance, strength, and independence, with high mortality and economic burden. Moreover, it brings serious mental and economic stress to patients and their families because of loss of independence. Current rehabilitation methods include standard therapy and electrical stimulation. This study introduces a novel hybrid approach combining use of an assistive device, the LegoPress, paired with closed-loop functional electrical stimulation for subacute stroke patients' lower limbs in a seated position, aiming to improve motor function particularly gait and balance.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 30 Jan 2025
- Start date
- Aug 2025
- Primary completion date
- May 2026
- Lead sponsor
- Ain Shams University
- Diseases
- Stroke
- NCT number
- NCT07090187
What you commit to
- Study type: Interventional
- Planned participants: 10
- From Aug 2025 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- \*Inclusion Criteria:\*
- Ages 18 to 70 (max of 70 years to avoid fatigue or exhaustion in elderly patients)
- Patients with acute ischemic or hemorrhagic stroke, verified by CT or MRI
- Patients with power in the paretic lower limb synergistic extension = 2 or more on the MRC scale
- \*Exclusion Criteria:\*
- Patients presenting with paraplegia, ataxia, or severe sensory impairment
- Patients with subarachnoid hemorrhage
- Subjects with implanted electronic devices, such as cardiac pacemakers or any metallic implants in the lower limbs
- Patients with other severe medical comorbidities, including:
- Severe osteoarthritis
- Liver dysfunction
- Kidney dysfunction
- Cardiovascular dysfunction
- Patients with severe cognitive impairment preventing task completion, verified by a score of less than 7 on the Abbreviated Mental Test (AMT)
- Patients who are:
- Uncooperative
- Hemodynamically unstable
- Have a disturbance of consciousness
- Patients with burns or any skin lesions at the sites of stimulation
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculty of medicine Ainshams University Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.