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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | No Intervention | 15 sessions standard physiotherapy (regular physiotherapy): 5 sessions per week, 1 per day, 3 weeks total. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LegoPress , Novel assistive device | Device | novel assistive device for rehabilitation using functional electrical stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
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. |
| Measure | Description | Time Frame |
|---|---|---|
| Over all functional improvement and Functional Independence |
|
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara M. Sara Mohammad Gaber Mahmoud, MD | Contact | +20 01122240327 | 01122240327 | Drsaramohammad33@gmail.com |
| Neivine M. Nevine El -Nahas, Professor | Contact | +20 12 27910517 | nevine_elnahas@med.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sara M. Sara Mohammad Gaber Mahmoud, MD | Ainshams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine Ainshams University | Cairo | Egypt |
Data will be available on reasonable request near publishing
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| 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 |