Improving STEP in Stroke Patients (I-STEP)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

Conditions: Hemiplegia Following Ischemic Stroke; Stroke; Spasticity as Sequela of Stroke; Gluteus Maximus Muscle Atrophy; Equinovarus Foot; Disability Physical

Treatments: Device: REMARCHE® shoes; Device: Sham REMARCHE® shoes

Study type: Interventional

Funder types: Other

Identifiers

NCT07403149

2025-A01226-43 (Other Identifier)

APHP250627

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

REMARCHE® shoes

Experimental group

Description:

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

Treatment:

Device: REMARCHE® shoes

Sham REMARCHE® shoes

Sham Comparator group

Description:

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

Treatment:

Device: Sham REMARCHE® shoes