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

NCT ID: NCT04323943

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-07
• Study Completion Date: 2021-11-23

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.

Conditions

Hemiparesis;Poststroke/CVA; Gait, Hemiplegic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ankle Foot orthosis (AFO)

Intervention Type: DEVICE

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

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.

Group Type: ACTIVE_COMPARATOR

Ankle Foot orthosis (AFO)

Intervention Type: DEVICE

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

Without orthosis (NO)

No orthosis - patient will wear only their shoes

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Sprystep (Thuasne)

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Saint-Etienne

OTHER

Sponsor Role: collaborator

Thuasne

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Calmels, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Saint Etienne, Bellevue

Locations

Chu Saint Etienne

Saint-Etienne, , France

Countries

France

Other Identifiers

ANSM

Identifier Type: OTHER

Identifier Source: secondary_id

EC28

Identifier Type: -

Identifier Source: org_study_id