Clinical trial NCT05977270: The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury
Official title: Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Brain Injuries, Traumatic
Lead sponsor: Lifebloom
Sponsor class: INDUSTRY
Collaborators: name: Pitié-Salpêtrière Hospital
First posted: 2023-08-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design with multiple baselines across individuals
Primary purpose: OTHER

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Assessment of daily time spent standing change
timeFrame: Change from baseline to intervention phase
Secondary outcomes:
measure: 10 meter walk test change
timeFrame: Change from baseline to intervention phase
measure: Functional Ambulation Categories (FAC) change
timeFrame: Change from baseline to intervention phase
measure: Berg Balance Scale change
timeFrame: Change from baseline to intervention phase
measure: Fatigue Severity Scale change
timeFrame: Change from baseline to intervention phase
measure: 6 minutes walk test
timeFrame: From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)
measure: Barthel Index (BI)
timeFrame: Before baseline, twice during the intervention phase, at immediate post-intervention
measure: Stroke Specific Quality of Life Scale
timeFrame: Before baseline, at immediate post-intervention
measure: Patient Health Questionnaire - 9
timeFrame: Before baseline, at immediate post-intervention
measure: Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
timeFrame: at immediate post-intervention
measure: Psychosocial Impact of Assistive Device Scale (F-PIADS)
timeFrame: at immediate post-intervention
Other outcomes:
Locations:
city: Paris
country: France
facility: Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital
Study officials:
affiliation: Pitié-Salpêtrière Hospital
name: Eleonore Bayen, PUPH
role: PRINCIPAL_INVESTIGATOR
References: