Novel Assistive Device and Functional Electrical Stimulation Therapy

Ain Shams University

Status: Not yet enrolling

Conditions: Rehabilitation

Treatments: Device: LegoPress , Novel assistive device

Study type: Interventional

Funder types: Other

Identifiers

NCT07090187

FMASU MD106/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 2 patient groups

LegoPress

Active Comparator group

Description:

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

Treatment:

Device: LegoPress , Novel assistive device

Control

No Intervention group

Description:

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