StrokeI-STEPNCT07403149
Improving STEP in Stroke Patients
A study testing REMARCHE® shoes in people with Stroke and Hemiplegia Following Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Stroke is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Hemiplegia Following Ischemic Stroke, Disability Physical
- What is being tested?
- REMARCHE® shoes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aged over 18 years
- With health insurance card " carte vitale " (being affiliated to the French security system) on "ALD" (Affection de longue durée) meaning reimbursement at a 100% rate
- With a past history of stroke (ischemic or hemorrhagic) with a Rankin score 2 to 4, once stabilized (no more improvement), at least 6 months after stroke onset
- Spasticity on one side of the body, with spastic walking, with tip-toeing gait, resulting in a "mowing wheats-like" movement of the leg as described in the French literature
- Patient had full medical examination prior to this research
- Informed and written consent of the participant.
Who cannot join
- Impossible to walk (wheel chair or bedridden)
- Diabetic foot
- Unhealed and/or painful foot injury
- Acquired deformity of a foot (osteophytosis, parrot beak on metatarso-phalangeal joint of the first ray, a bunion or hallux valgus, or hallux rigidus or stiffness of the big toe)
- Intercurrent disease that may interfere with the evaluation of the primary outcome (Parkinson's disease, peripheral neuropathy, Little's disease, significant hip or knee injury)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Improvement of Stepping Quality by Using Adapted Shoes
Stroke is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls.
Deambulation may need help (cane, crutch, tripod cane, walker). Lower limb spasticity includes hypertonia of extensors (gluteus maximus, quadriceps, posterior gastrocnemius) resulting in equinovarus. A neurology deficit may be present on ipsilateral lower limb flexors. Hence the patient walks with rubbing of the tip of the foot (tip-toeing gait), resulting in a "mowing wheatslike" movement of the leg as described in the French literature. Walking is then slowed down, unstable, with increased risk of falls.
In post stroke, during the period of rehabilitation and beyond, it is advisable to wear sports shoes although custom-made shoes improve walking and are reimbursed by the French social security system after prior agreement. Most of patients only wear conventional shoes.
- Conditions
- Stroke, Hemiplegia Following Ischemic Stroke, Disability Physical, Spasticity as Sequela of Stroke, Gluteus Maximus Muscle Atrophy, Equinovarus Foot
- Being tested
- REMARCHE® shoes, Sham REMARCHE® shoes
- Keywords
- Stroke, Hemiplegia, equinovarus, orthopedic shoes, REMARCHE® shoes, Walking performance
- Medical subject headings
- Stroke, Hemiplegia, Clubfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REMARCHE® shoesDevice
REMARCHE® shoes custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot
Sham REMARCHE® shoesDevice
Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance
| Study group | Role | What they receive |
|---|---|---|
| REMARCHE® shoes | Experimental | REMARCHE™ shoes are custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot Receives: Device: REMARCHE® shoes |
| Sham REMARCHE® shoes | Sham comparator | Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance. Receives: Device: Sham REMARCHE® shoes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in timed walking performance for 30 steps on the pathological side between D0 and D30.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Maison LLAFIA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07403149
- Sponsor's protocol ID
- APHP250627
- Other IDs
- 2025-A01226-43
- Acronym
- I-STEP
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Improvement of Stepping Quality by Using Adapted Shoes
- ClinicalTrials.gov ID
- NCT07403149
- Acronym / sponsor ID
- I-STEP / APHP250627
- Conditions
- Stroke, Hemiplegia Following Ischemic Stroke, Disability Physical, Spasticity as Sequela of Stroke, Gluteus Maximus Muscle Atrophy, Equinovarus Foot
- Keywords
- Stroke, Hemiplegia, equinovarus, orthopedic shoes, REMARCHE® shoes, Walking performance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Maison LLAFIA
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 11 Feb 2026 (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 is the leading cause of acquired disability in adults. Stroke causes death in 10% of patients, disability and functional handicap in 60% of cases. Sequelea of hemiplegia include spasticity resulting in great difficulty and slowness in walking, gait instability, increasing the risk of falls.
Deambulation may need help (cane, crutch, tripod cane, walker). Lower limb spasticity includes hypertonia of extensors (gluteus maximus, quadriceps, posterior gastrocnemius) resulting in equinovarus. A neurology deficit may be present on ipsilateral lower limb flexors. Hence the patient walks with rubbing of the tip of the foot (tip-toeing gait), resulting in a "mowing wheatslike" movement of the leg as described in the French literature. Walking is then slowed down, unstable, with increased risk of falls.
In post stroke, during the period of rehabilitation and beyond, it is advisable to wear sports shoes although custom-made shoes improve walking and are reimbursed by the French social security system after prior agreement. Most of patients only wear conventional shoes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REMARCHE® shoes | Experimental | Device: REMARCHE® shoesREMARCHE™ shoes are custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot |
| Sham REMARCHE® shoes | Sham comparator | Device: Sham REMARCHE® shoesSham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Aged over 18 years
- With health insurance card " carte vitale " (being affiliated to the French security system) on "ALD" (Affection de longue durée) meaning reimbursement at a 100% rate
- With a past history of stroke (ischemic or hemorrhagic) with a Rankin score 2 to 4, once stabilized (no more improvement), at least 6 months after stroke onset
- Spasticity on one side of the body, with spastic walking, with tip-toeing gait, resulting in a "mowing wheats-like" movement of the leg as described in the French literature
- Patient had full medical examination prior to this research
Key exclusion criteria (5 listed)
- Impossible to walk (wheel chair or bedridden)
- Diabetic foot
- Unhealed and/or painful foot injury
- Acquired deformity of a foot (osteophytosis, parrot beak on metatarso-phalangeal joint of the first ray, a bunion or hallux valgus, or hallux rigidus or stiffness of the big toe)
- Intercurrent disease that may interfere with the evaluation of the primary outcome (Parkinson's disease, peripheral neuropathy, Little's disease, significant hip or knee injury)
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 |
|---|---|---|
| REMARCHE® shoesREMARCHE® shoes custom-hand-made, with soles adapted to posture, integrated elevator splint, and raise of the tip of the shoes, and contra-lateral leg elevation to avoid friction of the tip of the ipsilateral foot | Device | REMARCHE® shoes |
| Sham REMARCHE® shoesSham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance | Device | Sham REMARCHE® shoes |
Primary outcome
Difference in timed walking performance for 30 steps on the pathological side between D0 and D30.
Time frame: Day 30
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 11 Feb 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing REMARCHE® shoes in people with Stroke and Hemiplegia Following Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. 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 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Pierre AMARENCO, Pr (+33 (0)1 40 25 87 25, pierre.amarenco@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in timed walking performance for 30 steps on the pathological side between D0 and D30. (time frame: Day 30). 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 11 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.