The Effects of Lifebloom One on Physical Activity After Acquired Brain Injury

Stroke Clinical Trial

— LBO_LCA  

Official title:

Evaluation of the Effects of Lifebloom One on Physical Activity After Acquired Brain Injury: A Single-Case Experimental Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977270
• Other study ID #: 2021-A00072-39
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Lifebloom
• Contact: Claire Kemlin, PhD
• Phone: +33633307568
• Email: claire.kemlin[@]lifebloom.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Stroke
• Wounds and Injuries

Intervention

Device:
• Lifebloom One
LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.

Locations

Country	Name	City	State
France	Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Lifebloom	Pitié-Salpêtrière Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of daily time spent standing change		Change from baseline to intervention phase
Secondary	10 meter walk test change		Change from baseline to intervention phase
Secondary	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).	Change from baseline to intervention phase
Secondary	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
Secondary	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
Secondary	6 minutes walk test		From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)
Secondary	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
Secondary	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
Secondary	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
Secondary	Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)		at immediate post-intervention
Secondary	Psychosocial Impact of Assistive Device Scale (F-PIADS)		at immediate post-intervention