StrokeLBO_LCANCT05977270
The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury
A study testing Lifebloom One in people with Stroke and Brain Injuries, Traumatic, run by Lifebloom at 1 site in France.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Brain Injuries, Traumatic
- What is being tested?
- Lifebloom One
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2023to 29 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
France1 site
Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital
Paris, 75013
About this study
Official title: Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study
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.
- Conditions
- Stroke, Brain Injuries, Traumatic
- Being tested
- Lifebloom One
- Medical subject headings
- Stroke, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifebloom OneDevice
LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.
| Study group | Role | What they receive |
|---|---|---|
| Lifebloom One intervention | Experimental | Not described Receives: Device: Lifebloom One |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of daily time spent standing change
Measured: Change from baseline to intervention phase
Secondary outcomes (10)
10 meter walk test change
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from baseline to intervention phase
6 minutes walk test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Before baseline, at immediate post-intervention
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Measured: at immediate post-intervention
Psychosocial Impact of Assistive Device Scale (F-PIADS)
Measured: at immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start15 Sep 2023
- Primary completion29 Aug 2024
- Study completion29 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Case Experimental Design with multiple baselines across individuals
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lifebloom
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Responsible party
- Sponsor
- Investigators
- Eleonore Bayen, PUPH, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977270
- Sponsor's protocol ID
- 2021-A00072-39
- Acronym
- LBO_LCA
- Status last verified
- Mar 2025
- First submitted
- 13 Jul 2023
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study
- ClinicalTrials.gov ID
- NCT05977270
- Acronym / sponsor ID
- LBO_LCA / 2021-A00072-39
- Conditions
- Stroke, Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- LifebloomIndustry (pharma, biotech, devices)
- Collaborators
- Pitié-Salpêtrière Hospital
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 29 Aug 2024 (actual)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Case Experimental Design with multiple baselines across individuals
| Arm | Type | Receives |
|---|---|---|
| Lifebloom One intervention | Experimental | Device: Lifebloom One |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifebloom OneLBO is made of Oxilio, an alternative to wheelchair placement for everyday use. | Device | Lifebloom One intervention |
Primary outcome
Assessment of daily time spent standing change
Time frame: Change from baseline to intervention phase
10 secondary outcomes
10 meter walk test change
Time frame: Change from baseline to intervention phase
Functional Ambulation Categories (FAC) change
Time frame: Change from baseline to intervention phase
Berg Balance Scale change
Time frame: Change from baseline to intervention phase
Fatigue Severity Scale change
Time frame: Change from baseline to intervention phase
6 minutes walk test
Time frame: From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)
Barthel Index (BI)
Time frame: Before baseline, twice during the intervention phase, at immediate post-intervention
Stroke Specific Quality of Life Scale
Time frame: Before baseline, at immediate post-intervention
Patient Health Questionnaire - 9
Time frame: Before baseline, at immediate post-intervention
Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Time frame: at immediate post-intervention
Psychosocial Impact of Assistive Device Scale (F-PIADS)
Time frame: at immediate post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleonore Bayen, PUPH principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifebloom One in people with Stroke and Brain Injuries, Traumatic, run by Lifebloom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of daily time spent standing change (time frame: Change from baseline to intervention phase). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.