Clinical trial NCT04323943: Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Gait, Hemiplegic
Lead sponsor: Thuasne
Sponsor class: INDUSTRY
Collaborators: name: University Hospital of Saint-Etienne
First posted: 2020-03-27
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, cross-over, open labelled, monocentric, controlled trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Distance walked during the 6 Minute Walk Test (6MWT)
timeFrame: Day : 14
Secondary outcomes:
measure: Energy cost
timeFrame: Day : 14
measure: Muscular activity
timeFrame: Day: 14
measure: Angle
timeFrame: Day : 14
measure: Perceived fatigue
timeFrame: Day : 14
measure: Power
timeFrame: Day : 14
measure: Momentum
timeFrame: Day : 14
measure: Satisfaction related to the device
timeFrame: Day : 42
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Chu Saint Etienne
Study officials:
affiliation: CHU Saint Etienne, Bellevue
name: Paul Calmels, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: