Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Injuries, Traumatic Stroke

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)
+5 more secondary outcomes

Study Arms (1)

Lifebloom One intervention

EXPERIMENTAL

Device: Lifebloom One

Interventions

Lifebloom OneDevice

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

Lifebloom One intervention

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Stroke or traumatic brain injury more than 2 months old
Unable to walk without assistance

Sponsors & Collaborators

Pitié-Salpêtrière Hospital
Othercollaborator
Lifebloom
Industrylead

Study Sites (1)

Physical Medicine and Rehabilitation Department - Pitié-Salpêtrière Hospital

Paris, 75013, France

MeSH Terms

Conditions

StrokeBrain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesBrain InjuriesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

Eleonore Bayen, PUPH
Pitié-Salpêtrière Hospital
PRINCIPAL INVESTIGATOR

Enrollment

5 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

July 13, 2023

First Posted

August 4, 2023

Study Start

September 15, 2023

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Lifebloom One intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (10)

Study Arms (1)

Lifebloom One intervention

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations