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NCT Number: NCT07090187

Novel Assistive Device and Functional Electrical Stimulation Therapy

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.

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Key information

Conditions

Rehabilitation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • *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

Treatment and study plan

LegoPress , Novel assistive device

Device

novel assistive device for rehabilitation using functional electrical stimulation

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.

    Time frame: 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.

    Objective:

    To quantify motor function improvements and Gait performance in patients undergoing combined Lego Press + Closed-Loop FES therapy with standard physiotherapy.

    Primary Outcomes

    • Motor Function

    Assessment Tool: Medical Research Council (MRC) scale for motor power.

    • 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)

Secondary outcomes

  1. Over all functional improvement and Functional Independence

    Time frame: 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

    • Overall Motor Function

    Assessment Tool: Fugl-Meyer Assessment for Lower Extremity (FMA-LE)

    Timepoints: t=0, t=1, t=2

    • Daily Living Functionality

    Functional Ambulation Category (FAC).

    Assessment Schedule:

    t=0: Baseline (before first session)

    t=1: Midpoint (after 7 sessions)

    t=2: Post-intervention (after 15 sessions, 3 weeks total)

Study contacts

Contact information is provided by the study sponsor or research team.

Neivine M. Nevine El -Nahas, Professor

CONTACT

[email protected]

+20 12 27910517

Sara M. Sara Mohammad Gaber Mahmoud, MD

CONTACT

[email protected]

+20 01122240327 ext. 01122240327

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Early Rehabilitation of Post Stroke Lower Limb Weakness Using Novel Assistive Device and Functional Electrical Stimulation Therapy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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