Improving STEP in Stroke Patients

NCT07403149 | Not Yet Recruiting

• 2 other identifiers: APHP2506272025-A01226-43
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

Stroke; Hemiplegia; equinovarus; orthopedic shoes; REMARCHE® shoes; Walking performance

Outcome Measures

Primary Outcomes (1)

• Difference in timed walking performance for 30 steps on the pathological side between D0 and D30.

  Day 30

Study Arms (2)

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

Device: REMARCHE® shoes

Sham REMARCHE® shoes

SHAM COMPARATOR

Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance.

Device: Sham REMARCHE® shoes

Interventions

REMARCHE® shoes DEVICE

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

REMARCHE® shoes

Sham REMARCHE® shoes DEVICE

Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance

Sham REMARCHE® shoes

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Maison LLAFIA: collaborator

MeSH Terms

Conditions

Stroke; Hemiplegia; Clubfoot

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Pierre AMARENCO, Pr

CONTACT

+33 (0)1 40 25 87 25; pierre.amarenco@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: February 11, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2025-11