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

NCT05131399 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-09-23

No results posted yet for this study

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.

Conditions

  • Neuropathy (Disorder)

Interventions

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

Sponsors & Collaborators

  • Thuasne

    lead INDUSTRY

Principal Investigators

  • Philippe THOUMIE, MD PhD · Hôpital Rothschild (Paris)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2024-09-30
Completion
2024-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05131399 on ClinicalTrials.gov