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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2019-A02957-50 |
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| Name | Class |
|---|---|
| University Hospital of Saint-Etienne | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbon-AFO (C-AFO) | Experimental | 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. |
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| Custom-made thermo-plastic orthosis (CM-AFO) | Active Comparator | Own custom-made thermo-plastic orthosis (CM-AFO) of patients. A familiarization will be performed also before doing the tests. |
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| Without orthosis (NO) | No Intervention | No orthosis - patient will wear only their shoes |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ankle Foot orthosis (AFO) | 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 :
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day : 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Energy cost | Energy cost will be assessed by oxygen consumption recorded during the 6MWT in the 3 conditions (C-AFO, CM-AFO, NO) | Day : 14 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Calmels, MD,PhD | CHU Saint Etienne, Bellevue | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint Etienne | Saint-Etienne | 42055 | France |
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Randomized, cross-over, open labelled, monocentric, controlled trial
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| Day: 14 |
| Angle | Angle (°) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions | Day : 14 |
| 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. | Day : 14 |
| Power | Power (watt) of ankle, knee and hip will be assessed in the 3 conditions before and after 6MWT during 5*15 m sessions | Day : 14 |
| 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 | Day : 14 |
| 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 | Day : 42 |
| ID | Term |
|---|---|
| D020233 | Gait Disorders, Neurologic |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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