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

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.

Study Overview

• Status: Completed
• Conditions: Gait, Hemiplegic; Hemiparesis;Poststroke/CVA
• Intervention / Treatment: Device: Ankle Foot orthosis (AFO)

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CHU Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbon-AFO (C-AFO); Manufactured carbon ankle foot orthosis (C-AFO) Sprystep (Thuasne) will be provided to patients. A familiarization with C-AFO will be performed before doing the tests.	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; Other Names: Sprystep (Thuasne)
Active Comparator: Custom-made thermo-plastic orthosis (CM-AFO); Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests.	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; Other Names: Sprystep (Thuasne)
No Intervention: Without orthosis (NO); No orthosis - patient will wear only their shoes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance walked during the 6 Minute Walk Test (6MWT)	Patient will performed three experimental session (14 days between each session) during wich the primary outcome will be assessed : one session while walking with C-AFO, one session while walking with CM-AFO, and one session while walking without AFO (randomized order). 6 Minute Walk Test is a beneficial tool to evaluate walking endurance in patients with poststroke hemiparesis	Day : 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Energy cost	Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO)	Day : 14
Muscular activity	Muscular activity will be assessed by electromyography (EMG) on different muscles (anterior tibial, gastroc medial, femoral). Muscular activity will be assessed before and after 6MWT during 5*15m sessions	Day: 14
Angle	Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions	Day : 14
Perceived fatigue	Perceived fatigue will be assessed by the Rated Perceived Exertion (RPE) scale before and after 6MWT. The RPE scale runs from 0 - 10. 0 is related to an easy activity and 10 (very, very heavy) is related to a very difficult activity.	Day : 14
Power	Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions	Day : 14
Momentum	Momemtum (J rad-1) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions	Day : 14
Satisfaction related to the device	A satisfaction survey will be asked in order to assess the positioning of AFO, comfort, esthetic and global satisfaction of devices	Day : 42

Collaborators and Investigators

• Sponsor: Thuasne
• Collaborators: University Hospital of Saint-Etienne
• Investigators: Principal Investigator: Paul Calmels, MD,PhD, CHU Saint Etienne, Bellevue

Study record dates

Study Major Dates

• Study Start (Actual): September 7, 2020
• Primary Completion (Actual): November 23, 2021
• Study Completion (Actual): November 23, 2021

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis; Gait Disorders, Neurologic
• Other Study ID Numbers: EC28; ANSM (Other Identifier: 2025-A02921-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No