Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343415
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-03-14
Brief Title:
Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness
Sponsor:
Christina Kruuse
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after acquired brain injury and disorders of consciousness The main questions it aims to answer are
Is the protocol feasible concerning inclusion in the study
Is the protocol feasible concerning protocol completion Participants will randomly be assigned to either five days of robot-assisted gait training GAIT two days of pause then five days of robot-assisted step training STEP or vice versa
The investigators will explore and compare safety events physiological measures and physical activity levels behavioural measures and functional disability outcomes Further the investigators report intervention and technical parameters in detail
Is the protocol feasible concerning inclusion in the study
Is the protocol feasible concerning protocol completion Participants will randomly be assigned to either five days of robot-assisted gait training GAIT two days of pause then five days of robot-assisted step training STEP or vice versa
The investigators will explore and compare safety events physiological measures and physical activity levels behavioural measures and functional disability outcomes Further the investigators report intervention and technical parameters in detail
Detailed Description:
This is a randomised cross-over feasibility trial carried out according to the Helsinki Declaration and approved by the scientific ethics committee of the Capital Region Denmark Participants are temporarily unable to consent why this obtained from the next of kin
Participants start the intervention when 10 minutes of standing in a tilt-table does not cause orthostatic hypotension Participants then recieve five days of intervention two days pause and then cross over to the other intervention
Groups
1 GAIT -- STEP
2 STEP -- GAIT
Participants start the intervention when 10 minutes of standing in a tilt-table does not cause orthostatic hypotension Participants then recieve five days of intervention two days pause and then cross over to the other intervention
Groups
1 GAIT -- STEP
2 STEP -- GAIT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None