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

NCT05977270 | Completed

• 1 other identifier: 2021-A00072-39
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Brain Injuries, Traumatic

Outcome Measures

Primary Outcomes (1)

• Assessment of daily time spent standing change

  Change from baseline to intervention phase

Secondary Outcomes (10)

• 10 meter walk test change

  Change from baseline to intervention phase

• Functional Ambulation Categories (FAC) change

  Change from baseline to intervention phase

• Berg Balance Scale change

  Change from baseline to intervention phase

• Fatigue Severity Scale change

  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)

Study Arms (1)

Lifebloom One intervention

EXPERIMENTAL

Device: Lifebloom One

Interventions

Lifebloom One DEVICE

LBO is made of Oxilio, an alternative to wheelchair placement for everyday use.

Lifebloom One intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Lifebloom: lead
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (1)

Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital

Paris, 75013, France

Location

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Eleonore Bayen, PUPH

  Pitié-Salpêtrière Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design with multiple baselines across individuals

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 4, 2023
• Study Start: September 15, 2023
• Primary Completion: August 29, 2024
• Study Completion: August 29, 2024
• Last Updated: March 10, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)