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| Name | Class |
|---|---|
| Pitié-Salpêtrière Hospital | OTHER |
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The goal of this clinical trial is to evaluate the effects of Lifebloom One in people who have suffered a stroke or a traumatic brain injury.
The main questions to be answered are:
Participants will use Lifebloom One during 8 weeks.
For each participant, gait and balance are compared either with and without Oxilio or before and after Lifebloom One intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifebloom One intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifebloom One | Device | LBO is made of Oxilio, an alternative to wheelchair placement for everyday use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of daily time spent standing change | Change from baseline to intervention phase |
| Measure | Description | Time Frame |
|---|---|---|
| 10 meter walk test change | Change from baseline to intervention phase | |
| Functional Ambulation Categories (FAC) change | 6-point scale. A score of 0 indicates that the patient is a non-functional ambulator, a score of 1, 2 or 3 denotes a dependent ambulator who requires assistance from another person in the form of continuous manual contact (1), continuous or intermittent manual contact (2), or verbal supervision/guarding (3) and a score of 4 or 5 describes an independent ambulator who can walk freely on: level surfaces only (4) or any surface (5=maximum score). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eleonore Bayen, PUPH | Pitié-Salpêtrière Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single Case Experimental Design with multiple baselines across individuals
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| Change from baseline to intervention phase |
| Berg Balance Scale change | In this 14-item scale, patients must maintain positions and complete moving tasks of varying difficulty. In most items, patients must maintain a given position for a specified time. Patients receive a score from 0-4 on their ability to meet these balance dimensions. A global score can be calculated out of 56. A score of 0 represents an inability to complete the item, and a score of 56 represents the ability to independently complete the item. | Change from baseline to intervention phase |
| Fatigue Severity Scale change | A 9-item questionnaire with questions related to how fatigue interferes with certain activities and rates its severity according to a self-report scale. The items are scored on a 7 point scale with 1 = strongly disagree and 7= strongly agree. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity. | Change from baseline to intervention phase |
| 6 minutes walk test | From the beginning and until the end of the intervention phase (during 8 weeks, one time per week) |
| Barthel Index (BI) | The score of the BI is a summed aggregate and there is preferential weighting on mobility and continence. The scores are allotted in the following way: 0 or 5 points per item for bathing and grooming; 0, 5, or 10 points per item for feeding, dressing, bowel control, bladder control, toilet use, and stairs; 0, 5, 10, or 15 points per item for transfers and mobility. The Index yields a total score out of 100 - the higher the score, the greater the degree of functional independence. | Before baseline, twice during the intervention phase, at immediate post-intervention |
| Stroke Specific Quality of Life Scale | It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning. | Before baseline, at immediate post-intervention |
| Patient Health Questionnaire - 9 | The PHQ-9 contains the 9 items. Each item is evaluated on a severity scale ranging from 0 to 3 where the respondent is asked to rate how often each symptom occurred over the last 2 weeks (0-not at all; 1-several days; 2-more than half of the days or 3-nearly every day), yielding a total score ranging from 0-27. Score interpretation:1-4 minimal depression; 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; and 20-27 severe depression. | Before baseline, at immediate post-intervention |
| Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) | at immediate post-intervention |
| Psychosocial Impact of Assistive Device Scale (F-PIADS) | at immediate post-intervention |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |