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| Name | Class |
|---|---|
| Pôle Saint Hélier | OTHER |
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The aim of this randomized, cross-over, multi-center, intention-to-treat, open-label study study is to determine the benefits of the NEUROSWING device on gait speed in patients with dorsal and/or plantar flexor deficits, compared with the use of a carbon orthosis. Each patient will benefit in random order from a 14-day investigation period with the NEUROSWING device and a 14-day control period with a carbon orthosis. These two 2-week periods will be separated by one week, during which no orthosis will be worn and no evaluation will be carried out. Patients will be randomized to determine which phase they will start with. The primary endpoint is walking speed, which will be measured by comparing the results of the 10-meter walk test. For the secondary endpoints, patients will be assessed using the Functional Gait Assessment (FGA), the 6-minute test and an analysis system that will analyze other gait parameters (duration of the different phases of the gait cycle, cadence and step length). In order to carry out the assessments, each patient included will have 12 visits spread over 5 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition A | Active Comparator | Condition A corresponds to the control phase where the patient will use the control device during 14 days. |
|
| Condition B | Experimental | Condition B corresponds to the experimental phase where the patient will use the experimental device during 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEUROSWING Orthosis (experimental) : carbon orthosis with an active ankle articulation | Device | The patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in :
|
| Measure | Description | Time Frame |
|---|---|---|
| Walking speed : 10m walk test | At all 12 visits from baseline (day 1), to end of study (day 35) |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Gait Assessment (FGA) | The Functional Gait Assessment (FGA) is a modification of the Dynamic Gait Index (DGI) that uses higher-level tasks to increase the applicability of the test to people with vestibular disorders and to eliminate the ceiling effect of the original test. Three items were added to the DGI because these were noted to be difficult in people with vestibular disorders. The FGA is used to assess postural stability during various walking tasks :
|
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Inclusion Criteria:
18 years of age and older
Deficit of the dorsal and/or plantar flexors with at least one of the following components specific to the indication of an AFO:
Ambulation possible with or without technical aids
First time using an orthosis used in the study
Being followed in one of the investigating centers whose management and rehabilitation in line with the study's visit schedule.
Having freely consented to participate
Affiliated with a social security scheme
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Leblong | Contact | +33299295099 | emilie.leblong@fondationsainthelier.com |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Leblong | Fondation Saint Helier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IMPR du Bois de Lébisey | Hérouville-Saint-Clair | 14200 | France |
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|
| Carbon orthosis (control) | Device | The patients will use the experimental device during 14 days straight as well, then a washout period of 7 days with no interventons and then the comparator during 14 days straight. The order in which they will use each device will depend on the groupe they have been randomized in :
|
|
| At baseline (day 1), day 14, day 22 and end of study (day 35) |
| 6 minute walk test | At baseline (day 1), day 14, day 22 and end of study (day 35) |
| Spatio-temoral gait analysis | At baseline (day 1), day 14, day 22 and end of study (day 35) |
| CMPR Bel-Air | La Membrolle-sur-Choisille | 37390 | France |
|
| ID | Term |
|---|---|
| D020521 | Stroke |
| D009103 | Multiple Sclerosis |
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001925 | Brain Damage, Chronic |
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