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Clinical Trial 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 traumatic 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.


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06343415
Study type Interventional
Source Rigshospitalet, Denmark
Contact Vibeke Wagner, MSc
Phone +4538631600
Email vibeke.wagner@regionh.dk
Status Recruiting
Phase N/A
Start date April 16, 2024
Completion date July 31, 2025

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