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Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study

NCT04323943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-01-11

No results posted yet for this study

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 dorsiflexors and increased spasticity and stiffness of the plantar-flexors. As a consequence, walking performances are reduced and energy cost of walking is deteriorated. This may increase performance fatigability, as the locomotion will be realized at a higher percentage of the subjects' capacities. In order to overcome these issues, different treatments are proposed. One of the most conventional solutions are the use of ankle foot orthosis (AFO) and it is the most commonly prescribed device used to compensate for "foot drop". There is a very large choice of AFO on the market which can be proposed to patients with foot drop.

The aim of this study is thus to assess the mechanical effects of using a manufactured carbon AFO in by comparison to a custom-made thermo-plastic AFO on walking capacity (distance and energy cost), fatigue and "foot drop" control throughout the gait phase in patients with hemiparetic stroke.

Conditions

  • Hemiparesis;Poststroke/CVA
  • Gait, Hemiplegic

Interventions

DEVICE

Ankle Foot orthosis (AFO)

The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order). Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4. During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order : * 5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured * 6MWT where energy cost will be measured * 5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed

Sponsors & Collaborators

  • University Hospital of Saint-Etienne

    collaborator OTHER

  • Thuasne

    lead INDUSTRY

Principal Investigators

  • Paul Calmels, MD,PhD · CHU Saint Etienne, Bellevue

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-07
Primary Completion
2021-11-23
Completion
2021-11-23

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 NCT04323943 on ClinicalTrials.gov