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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 (MECASPRY)

Primary Purpose

Hemiparesis;Poststroke/CVA, Gait, Hemiplegic

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Ankle Foot orthosis (AFO)

About this trial

This is an interventional treatment trial for Hemiparesis;Poststroke/CVA

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chu Saint Etienne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Carbon-AFO (C-AFO)

Custom-made thermo-plastic orthosis (CM-AFO)

Without orthosis (NO)

Arm Description

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.

Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests.

No orthosis - patient will wear only their shoes

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Energy cost

Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO)

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

Angle

Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

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.

Power

Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

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

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

Full Information

NCT ID

NCT04323943

First Posted

March 19, 2020

Last Updated

January 10, 2022

Sponsor

Thuasne

Collaborators

University Hospital of Saint-Etienne

1. Study Identification

Unique Protocol Identification Number

NCT04323943

Brief Title

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

Acronym

MECASPRY

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

September 7, 2020 (Actual)

Primary Completion Date

November 23, 2021 (Actual)

Study Completion Date

November 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Thuasne

Collaborators

University Hospital of Saint-Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemiparesis;Poststroke/CVA, Gait, Hemiplegic

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

Randomized, cross-over, open labelled, monocentric, controlled trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Carbon-AFO (C-AFO)

Arm Type

Experimental

Arm Description

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.

Arm Title

Custom-made thermo-plastic orthosis (CM-AFO)

Arm Type

Active Comparator

Arm Description

Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests.

Arm Title

Without orthosis (NO)

Arm Type

No Intervention

Arm Description

No orthosis - patient will wear only their shoes

Intervention Type

Device

Intervention Name(s)

Ankle Foot orthosis (AFO)

Other Intervention Name(s)

Sprystep (Thuasne)

Intervention Description

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

Primary Outcome Measure Information:

Title

Distance walked during the 6 Minute Walk Test (6MWT)

Description

Time Frame

Day : 14

Secondary Outcome Measure Information:

Title

Energy cost

Description

Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO)

Time Frame

Day : 14

Title

Muscular activity

Description

Time Frame

Day: 14

Title

Angle

Description

Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

Time Frame

Day : 14

Title

Perceived fatigue

Description

Time Frame

Day : 14

Title

Power

Description

Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions

Time Frame

Day : 14

Title

Momentum

Description

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

Time Frame

Day : 14

Title

Satisfaction related to the device

Description

A satisfaction survey will be asked in order to assess the positioning of AFO, comfort, esthetic and global satisfaction of devices

Time Frame

Day : 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Calmels, MD,PhD

Organizational Affiliation

CHU Saint Etienne, Bellevue

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Saint Etienne

City

Saint-Étienne

ZIP/Postal Code

42055

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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