NCT05131399

Contribution of an Off-the-shelf Carbon Ankle Foot Orthosis (AFO) in the Management of Walking Functional Impairment

Single Case Experimental Design (SCED) Comparing an Off-the-shelf Carbon Ankle Foot Orthosis (SPRYSTEP) Versus an off-the Shelf Standard Plastic Ankle Foot Orthosis in the Treatment of Walking Functional Impairment

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Thuasne · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device Ankle Foot Orthosis (AFO) compared to a standard plastic ankle foot orthosis.

Detailed description

Foot drop is a symptom observed in various pathologies including neuro-muscular pathologies of peripheral or central origin. It is a walking disability, causing a deterioration in the patients autonomy and quality of life. The current medical strategy focuses on various off-the-shelf or custom made devices, depending on the walking functional impairment and the characteristics of foot deformities. The objective of this study is to assess the superiority in achieving personal goals (set by the patient and the medical team) according to the GAS scale (Goal Attainment Scaling) while wearing the carbon medical device ankle foot orthosis compared to a standard plastic ankle foot orthosis.

Conditions

• Neuropathy (Disorder)

Interventions

Type	Name	Description
DEVICE	Phase A1	Plastic standard ankle foot orthosis
DEVICE	Phase B1	carbon medical device ankle foot orthosis
DEVICE	Phase A2	Plastic standard ankle foot orthosis
DEVICE	Phase B2	carbon medical device ankle foot orthosis

Timeline

• Start date: 2022-02-28
• Primary completion: 2024-09-01
• Completion: 2024-11-01
• First posted: 2021-11-23
• Last updated: 2024-09-23

Locations

8 sites across 1 country: France