Comparison of Thermo-plastic Versus Carbon Foot Ankle Orthosis to Improve Gait and Reduce Fatigue in Post-stroke Patients: a Biomechanical and Neurophysiological Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thuasne
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Distance walked during the 6 Minute Walk Test (6MWT)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Ankle Foot orthosis (AFO) (Device)
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.
Intervention: Ankle Foot orthosis (AFO) (Device)
Without orthosis (NO)
No orthosis - patient will wear only their shoes
Outcomes
Primary Outcomes
Distance walked during the 6 Minute Walk Test (6MWT)
Time Frame: Day : 14
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 Outcomes
- Angle(Day : 14)
- Energy cost(Day : 14)
- Muscular activity(Day: 14)
- Perceived fatigue(Day : 14)
- Power(Day : 14)
- Momentum(Day : 14)
- Satisfaction related to the device(Day : 42)