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Not yet recruiting NCT07090187

Novel Assistive Device and Functional Electrical Stimulation Therapy

No phase Interventional Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LegoPress , Novel assistive device.
Who it may be relevant to
Registry conditions: Rehabilitation. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device LegoPress , Novel assistive device
    novel assistive device for rehabilitation using functional electrical stimulation

Primary outcome measures

  • 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.]
Secondary outcome measures (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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Device feasibility

Study locations

Egypt · 1 center
  • Faculty of medicine Ainshams University — Cairo

Identifiers

NCT: NCT07090187 · FMASU MD106/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗