Brain Injuries, Traumatic, Stroke
Conditions
Brief summary
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: * Does Lifebloom One allow users to spend more time standing each day? * Does Lifebloom One allow users to improve their balance and gait? 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.
Interventions
DEVICELifebloom One
LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.
Sponsors
Pitié-Salpêtrière Hospital
Lifebloom
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Single Case Experimental Design with multiple baselines across individuals
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Stroke or traumatic brain injury more than 2 months old * Unable to walk without assistance * Expected length of stay equal to or greater than 4 months
Exclusion criteria
* Anthropometric incompatibility with Oxilio * Unable to walk prior to brain injury * No functional upper limb * Complete sensory deficit in the lower limb(s) * Degenerative impairment (tumor, neurodegenerative disease, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of daily time spent standing change | Change from baseline to intervention phase |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Ambulation Categories (FAC) change | Change from baseline to intervention phase | 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). |
| Berg Balance Scale change | Change from baseline to intervention phase | 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. |
| Fatigue Severity Scale change | Change from baseline to intervention phase | 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. |
| 6 minutes walk test | From the beginning and until the end of the intervention phase (during 8 weeks, one time per week) | — |
| 10 meter walk test change | Change from baseline to intervention phase | — |
| Stroke Specific Quality of Life Scale | Before baseline, at immediate post-intervention | It is a self-report scale containing 49 items. Items are rated on a 5-point Likert scale. Higher scores indicate better functioning. |
| Patient Health Questionnaire - 9 | Before baseline, at immediate post-intervention | 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. |
| 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 | — |
| Barthel Index (BI) | Before baseline, twice during the intervention phase, at immediate post-intervention | 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. |
Countries
France
Outcome results
None listed