Novel Assistive Device and Functional Electrical Stimulation Therapy

NCT07090187 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD106/2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Efficacy and tolerability of LegoPress device in conjunction with functional electrical stimulation (FES) on the paretic lower limb in acute stroke patients.

  Objective: To quantify motor function improvements and Gait performance in patients undergoing combined Lego Press + Closed-Loop FES therapy with standard physiotherapy. Primary Outcomes 1. Motor Function Assessment Tool: Medical Research Council (MRC) scale for motor power. 2. Gait Speed 10-Meter Walk Test (10MWT) Timed Up and Go Test (TUG) Assessment Schedule: t=0: Baseline (before first session) t=1: Midpoint (after 7 sessions) t=2: Post-intervention (after 15 sessions, 3 weeks total)

  For each participant in intervention group: 15 sessions of Lego Press + closed loop FES. Combined with 15 sessions of regular physiotherapy5 sessions per week, 1 per day, 3 weeks total.

Secondary Outcomes (1)

• Over all functional improvement and Functional Independence

  Each participant will undergo: 15 sessions of Lego Press + closed-loop Functional Electrical Stimulation (FES) 15 sessions of conventional physiotherapy 5 sessions/week, 1 session/day over 3 weeks

Study Arms (2)

LegoPress

ACTIVE COMPARATOR

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

Device: LegoPress , Novel assistive device

Control

NO INTERVENTION

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

Interventions

LegoPress , Novel assistive device DEVICE

novel assistive device for rehabilitation using functional electrical stimulation

LegoPress

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine Ainshams University

Cairo, Egypt

Location

Study Officials

• Sara M. Sara Mohammad Gaber Mahmoud, MD

  Ainshams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara M. Sara Mohammad Gaber Mahmoud, MD

CONTACT

+20 01122240327; Drsaramohammad33@gmail.com

Neivine M. Nevine El -Nahas, Professor

CONTACT

+20 12 27910517; nevine_elnahas@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor Neurology specialist

Study Record Dates

• First Submitted: January 30, 2025
• First Posted: July 29, 2025
• Study Start: August 15, 2025
• Primary Completion: May 15, 2026
• Study Completion (Estimated): June 3, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)