Clinical trial NCT06343415: Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness
Official title: Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acquired Brain Injury
Disorders of Consciousness
Keywords: Brain injury
Traumatic brain injury
consciousness
robot-assisted gait training
tilt-table
feasibility
cross-over study
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: AB - BA
Primary purpose: OTHER

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.

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

Eligibility criteria: 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)
* 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
* 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

Primary outcomes:
measure: Inclusion Rate
timeFrame: 26 days from intervention start
measure: Completion Ratio of protocols
timeFrame: 26 days from intervention start
Secondary outcomes:
measure: Exploratory Safety Outcomes
timeFrame: 26 days from intervention start
Other outcomes:
measure: Disability Rating Scale (DRS)
timeFrame: 26 days from intervention start
measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness
timeFrame: 26 days from intervention start
measure: Early Functional Abilities (EFA)
timeFrame: 26 days from intervention start
measure: Functional Independence Measure (FIM)
timeFrame: 26 days from intervention start
measure: Physical activity intensity
timeFrame: during intervention period (10 days) during training sessions
measure: Mean arterial pressure (MAP)
timeFrame: during intervention period (10 days), after training sessions
measure: Heart Rate Variability (HRV)
timeFrame: during intervention period (10 days), end of intervention
measure: Behavioural Outcome
timeFrame: First and last session of each arm (30 minutes, 4 sessions per participant)
Locations:
city: Glostrup
country: Denmark
facility: Department of brain and spinal cord injury
state: Greater Copenhagen
Study officials:
affiliation: Rigshospitalet, Denmark
name: Christina Kruuse, Professor
role: STUDY_DIRECTOR
References: