Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness

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

INCLUSION CRITERIA

• Admitted for rehabilitation at the Department of Brain and Spinal Cord Injury, Division of Brain Injury, Bodil Eskesen Centre, Rigshospitalet
• Patients 18 years or older
• In the unresponsive wakefulness or minimally conscious state after a moderate to severe acquired brain injury (ICD 10: S06, Intracranial injury; I60-I69, Cerebrovascular diseases).
• Revised 11 November 2024: In the unresponsive wakefulness state, minimally conscious state or in the confusional state after a moderate to severe acquired brain injury (ICD 10: S06, Intracranial injury; I60-I69, Cerebrovascular diseases).
• Obtained consent from nearest relative and study guardian.

EXCLUSION CRITERIA

• Weight > 135 kg (maximum weight for the Erigo® tilt table)
• Height > 200 cm (maximum height for the Lokomat®)
• In the confusional state or emerged to full consciousness Revised 11 November 2024: Emerged to full consciousness
• If weight bearing is restricted due to, e.g., fractures of the spine, pelvis, or lower limbs.
• Known osteoporosis of a severity where use of robotic orthoses, according to a physician, is considered a contraindication
• If lower limb joints are fixated to a degree that cannot be compensated in the orthoses
• No valid consent from the nearest relative or study guardian