Improving STEP in Stroke Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Clubfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disability Physical Equinovarus Foot Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Gluteus Maximus Muscle Atrophy Hemiplegia Hemiplegia Following Ischemic Stroke Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity as Sequela of Stroke Talipes Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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)

Treatment and study plan

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

Sham REMARCHE® shoes

Device

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

Primary outcomes

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

Time frame: Day 30

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre AMARENCO, Pr

CONTACT

[email protected]

+33 (0)1 40 25 87 25

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

Maison LLAFIA

Registry information

Official study title

Evaluating the Improvement of Stepping Quality by Using Adapted Shoes

Acronym: I-STEP

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Feb 11, 2026
Registry last updated: Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting