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Completed

NCT Number: NCT05977270

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital

Paris, 75013, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Lifebloom One

Device

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

Primary outcomes

  1. Assessment of daily time spent standing change

    Time frame: Change from baseline to intervention phase

Secondary outcomes

  1. 10 meter walk test change

    Time frame: Change from baseline to intervention phase

  2. Functional Ambulation Categories (FAC) change

    Time frame: 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).

  3. Berg Balance Scale change

    Time frame: 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.

  4. Fatigue Severity Scale change

    Time frame: 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.

  5. 6 minutes walk test

    Time frame: From the beginning and until the end of the intervention phase (during 8 weeks, one time per week)

  6. Barthel Index (BI)

    Time frame: 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.

  7. Stroke Specific Quality of Life Scale

    Time frame: 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.

  8. Patient Health Questionnaire - 9

    Time frame: 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.

  9. Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)

    Time frame: at immediate post-intervention

  10. Psychosocial Impact of Assistive Device Scale (F-PIADS)

    Time frame: at immediate post-intervention

Sponsors and collaborators

Lead sponsor

Lifebloom

Industry

Collaborators

  • Pitié-Salpêtrière Hospital

Registry information

Official study title

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

Acronym: LBO_LCA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2023
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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