Improving STEP in Stroke Patients (I-STEP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke; Disability Physical; Spasticity as Sequela of Stroke; Hemiplegia Following Ischemic Stroke; Equinovarus Foot; Gluteus Maximus Muscle Atrophy
• Intervention / Treatment: Device: REMARCHE® shoes; Device: Sham REMARCHE® shoes

• Study Type: Interventional
• Enrollment (Estimated): 58
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pierre AMARENCO, Pr; Phone Number: +33 (0)1 40 25 87 25; Email: pierre.amarenco@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Aged over 18 years
2. 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
3. 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
4. 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
5. Patient had full medical examination prior to this research
6. Informed and written consent of the participant.

Exclusion Criteria:

1. Impossible to walk (wheel chair or bedridden)
2. Diabetic foot
3. Unhealed and/or painful foot injury
4. 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)
5. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REMARCHE® shoes; 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	Device: REMARCHE® shoes; 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 Comparator: Sham REMARCHE® shoes; Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance.	Device: Sham REMARCHE® shoes; Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in timed walking performance for 30 steps on the pathological side between D0 and D30.	Day 30

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Maison LLAFIA

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 23, 2025
• First Submitted That Met QC Criteria: February 4, 2026
• First Posted (Actual): February 11, 2026

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 4, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Hemiplegia; Walking performance; orthopedic shoes; equinovarus; REMARCHE® shoes
• Additional Relevant MeSH Terms: Talipes; Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Paralysis; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemiplegia; Clubfoot
• Other Study ID Numbers: APHP250627; 2025-A01226-43 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No