RehabilitationNCT07090187
Novel Assistive Device and Functional Electrical Stimulation Therapy
A study testing LegoPress , Novel assistive device in people with Rehabilitation, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- LegoPress , Novel assistive device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2025to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- *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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara M. Sara Mohammad Gaber Mahmoud, MD contact
Egypt1 site
Faculty of medicine Ainshams University
Cairo
Ahmed E. ahmed elbokl, Professor, +20 12 22354010, ahmed.elbokl@med.asu.edu.eg
Nevine M. nevine elnahas, Professor, +20 12 27910517, nevine_elnahas@med.asu.edu.eg
About this study
Official title: Early Rehabilitation of Post Stroke Lower Limb Weakness Using 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.
Read the 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.
- Conditions
- Rehabilitation
- Being tested
- LegoPress , Novel assistive device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LegoPress , Novel assistive deviceDevice
novel assistive device for rehabilitation using functional electrical stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: LegoPress , Novel assistive device |
| Control | No intervention | 15 sessions standard physiotherapy (regular physiotherapy): 5 sessions per week, 1 per day, 3 weeks total. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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)
Measured: 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
- 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 May 2026 (estimated)
- Study completion3 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara mohammad, Ain Shams University
- Investigators
- Sara M. Sara Mohammad Gaber Mahmoud, MD, Principal investigator, Ainshams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090187
- Sponsor's protocol ID
- FMASU MD106/2024
- Status last verified
- Jan 2025
- First submitted
- 30 Jan 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available on reasonable request near publishing
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Rehabilitation of Post Stroke Lower Limb Weakness Using Novel Assistive Device and Functional Electrical Stimulation Therapy
- ClinicalTrials.gov ID
- NCT07090187
- Acronym / sponsor ID
- FMASU MD106/2024
- Conditions
- Rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 3 Jun 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LegoPress | Active comparator | Device: LegoPress , Novel assistive device15 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LegoPress , Novel assistive devicenovel assistive device for rehabilitation using functional electrical stimulation | Device | LegoPress |
Primary outcome
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 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)
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No. Data will be available on reasonable request near publishing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara M. Sara Mohammad Gaber Mahmoud, MD contact
Sara M. Sara Mohammad Gaber Mahmoud, MD principal investigator
Ainshams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LegoPress , Novel assistive device in people with Rehabilitation, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara M. Sara Mohammad Gaber Mahmoud, MD (+20 01122240327 ext. 01122240327, Drsaramohammad33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025.