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Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial.
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of brain and spinal cord injury
Glostrup Municipality, Greater Copenhagen, Denmark
Start Date
August 12, 2024
Primary Completion Date
April 1, 2025
Completion Date
April 1, 2025
Last Updated
March 11, 2026
10
ACTUAL participants
GAIT-assisted training
OTHER
STEP-assisted training
OTHER
Lead Sponsor
Christina Kruuse
NCT07378592
NCT06774287
NCT06323031
Data Source & Attribution
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