Status:
COMPLETED
Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
Lead Sponsor:
Thuasne
Collaborating Sponsors:
University Hospital of Saint-Etienne
Conditions:
Hemiparesis;Poststroke/CVA
Gait, Hemiplegic
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Approximately 20% of stroke survivors have difficulties to dorsiflex the ankle and clear the ground during walking. This impairment, termed as "foot drop", is caused by an association of weak dorsifle...
Eligibility Criteria
Inclusion
- Hemiparetic patients, walking with CM-AFO
- Diagnosis of a first stroke since at least 6 months with medical conditions of stroke known, treatment proposed, cardio-vascular and neurological state stabilized
- Foot drop observed during the swing phase of gait, requiring the use of a custom-made plastic orthosis that has been used for at least 3 months and used for less than 2 years
- Muscle spasticity not higher than grade 3 according to the Modified Ashworth Scale
- Sufficient motor ability and endurance to ambulate at least 15 m independently without AFO
- Patient who signed a consent
- Patients affiliated or entitled to a social security system.
Exclusion
- Patients who did not have brain MRI imaging after their stroke to confirm the diagnosis of stroke,
- Patients with an associated cerebellar syndrome,
- Patients with clinical brainstem involvement (cranial pair deficit),
- Patients with a neurological history other than stroke that has an impact on walking,
- Patients with unstable cardiovascular or respiratory disorders likely to induce gait disorders that may influence the performance of the tests to a greater extent than in the case of vascular hemiplegics,
- Patients with alcohol or drug dependence,
- Patients with psychiatric illness, cognitive impairment, uncontrolled disease/epilepsy, malignant pathology, renal impairment, unstable or decompensated diabetes, severe,
- Patients with a history of associated disabling systemic disease,
- Patients who refused to sign the written consent,
- Patients with a current pregnancy,
- Patients under court protection.
Key Trial Info
Start Date :
September 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 23 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04323943
Start Date
September 7 2020
End Date
November 23 2021
Last Update
January 11 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chu Saint Etienne
Saint-Etienne, France, 42055