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)

THUASNE

Status

Completed

Conditions

Hemiparesis;Poststroke/CVA

Gait, Hemiplegic

Treatments

Device: Ankle Foot orthosis (AFO)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04323943

ANSM (Other Identifier)

EC28

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 3 patient groups

Carbon-AFO (C-AFO)

Experimental group

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.

Treatment:

Device: Ankle Foot orthosis (AFO)

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

Active Comparator group

Description:

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

Treatment:

Device: Ankle Foot orthosis (AFO)

Without orthosis (NO)

No Intervention group

Description:

No orthosis - patient will wear only their shoes