NCT07403149

Improving STEP in Stroke Patients

Evaluating the Improvement of Stepping Quality by Using Adapted Shoes

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
DEVICE	Sham REMARCHE® shoes	Sham REMARCHE® shoes, custom-hand-made conventional shoes, with same appearance

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2026-02-11
• Last updated: 2026-02-11