Novel Assistive Device and Functional Electrical Stimulation Therapy

NCT ID: NCT07090187

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2026-06-03

Brief Summary

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.

Detailed Description

The LegoPress is a passive assistive device that allows patients to undergo FES therapy while remaining in seated position. This is crucial for stroke patients as in the early acute phase they are at a higher risk of falling due to balance and mobility issues. The LegoPress is equipped with potentiometers and force sensors to measure the distance and force in flexion and extension. Therefore, when the LegoPress paired with FES, it can be performed in a closed loop where a maximum current is set for patient safety and can provide flexion/extension. Then based off this current the stimulation current can be modulated according to the position desired by the clinician. It can also be an alternative to cycling FES by featuring different movement functions such as simultaneous leg press action (in tandem), gait-simulation action (closest to walking), or sequential (one leg after the other).

The efficacy of the LegoPress FES protocol has yet to be tested in the clinic and with stroke patients, this study therefore is motivated by investigating the feasibility of this proposed novel method as well as its clinical outcomes.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

LegoPress

15 sessions of Lego Press + closed loop FES. Combined with 15 sessions of regular physiotherapy5 sessions per week, 1 per day, 3 weeks total.

Group Type: ACTIVE_COMPARATOR

LegoPress , Novel assistive device

Intervention Type: DEVICE

novel assistive device for rehabilitation using functional electrical stimulation

Control

15 sessions standard physiotherapy (regular physiotherapy): 5 sessions per week, 1 per day, 3 weeks total.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

LegoPress , Novel assistive device

novel assistive device for rehabilitation using functional electrical stimulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

sara mohammad

Doctor Neurology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara M. Sara Mohammad Gaber Mahmoud, MD

Role: PRINCIPAL_INVESTIGATOR

Ainshams University

Locations

Faculty of medicine Ainshams University

Cairo, , Egypt

Countries

Egypt

Central Contacts

Sara M. Sara Mohammad Gaber Mahmoud, MD

Role: CONTACT

Drsaramohammad33@gmail.com

+20 01122240327 ext. 01122240327

Neivine M. Nevine El -Nahas, Professor

Role: CONTACT

nevine_elnahas@med.asu.edu.eg

+20 12 27910517

Facility Contacts

Ahmed E. ahmed elbokl, Professor

Role: primary

ahmed.elbokl@med.asu.edu.eg

+20 12 22354010

Nevine M. nevine elnahas, Professor

Role: backup

nevine_elnahas@med.asu.edu.eg

+20 12 27910517

Other Identifiers

FMASU MD106/2024

Identifier Type: -

Identifier Source: org_study_id