Using a carbon ankle foot orthosis to improve walking in patients with foot drop
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
NA · Thuasne · NCT05131399
This study is testing if a new carbon ankle foot orthosis can help people with foot drop walk better and reach their personal rehab goals compared to a standard plastic one.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thuasne (industry) |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT05131399 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a carbon ankle foot orthosis (AFO) in helping patients with walking functional impairments achieve their personal rehabilitation goals, compared to a standard plastic AFO. Patients with foot drop, a condition that affects their ability to walk, will be assessed using the Goal Attainment Scaling (GAS) method to measure improvements. The study will involve multiple phases of intervention to determine the best outcomes for participants. By focusing on individual goals set by both patients and medical teams, the study seeks to enhance the quality of life for those affected by this condition.
Who should consider this trial
Good fit: Ideal candidates include patients with foot levator muscle impairment and instability of the back of the foot who are unable to stand on tip-toe.
Not a fit: Patients with fixed varus-equine foot or those with uncontrolled spasticity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve walking ability and overall quality of life for patients with foot drop.
How similar studies have performed: Other studies have shown promising results with similar orthotic interventions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient with a foot levator muscles impairment (single or bilateral drop foot) and / or instability of the back of the foot, associated with a deficit of the triceps * Patient with inability to stand on tip-toe on one foot * Patient having signed a free and informed consent * Patient affiliated or entitled to a social security scheme Exclusion Criteria: * Patient with fixed varus-equine foot * Patient with an unstable skin condition (whether or not treated with additional treatment that may change the footwear) * Patient with a a foot levator muscles impairment with a deficiency of the quadriceps and hamstrings (knee involvement) * Patient with uncontrolled spasticity * Patient for whom foot surgery is planned during the study * Patient with one of the contraindications to the use of carbon medical device, indicated in the instructions for use * Patient with one of the contraindications to the use of the standard plastic ankle foot orthosis, indicated in the instructions for use * Patient with orthopedic comorbidities affecting the musculoskeletal system * Pregnant woman * Patient with major cognitive impairment incompatible with participation in a clinical trial * Patient participating in another clinical investigation conducted to establish the compliance of a MD impacting the evaluation criteria * Patient who cannot be followed for 12 weeks * Vulnerable patient according to article L1121-6 of the public health code, persons subject to a measure of judicial protection or unable to consent freely
Where this trial is running
Angers and 7 other locations
- Ch Les Capucins — Angers, France (RECRUITING)
- Chu Dijon — Dijon, France (RECRUITING)
- CH LAVAL — Laval, France (RECRUITING)
- CHU Lille — Lille, France (RECRUITING)
- centre Louis PIERQUIN — Nancy, France (NOT_YET_RECRUITING)
- CHU Nantes — Nantes, France (RECRUITING)
- Hôpital Rothschild — Paris, France (RECRUITING)
- CHU Strasbourg — Strasbourg, France (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Philippe THOUMIE, MD PhD — Hôpital Rothschild (Paris)
- Study coordinator: Philippe THOUMIE, MD PhD
- Email: philippe.thoumie@aphp.fr
- Phone: (0)140193534
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Neuropathy, orthosis, functional walking impairment, foot drop, rehabilitation, GAS