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

Christina Kruuse

Status: Enrolling

Conditions: Acquired Brain Injury; Disorders of Consciousness

Treatments: Other: STEP-assisted training; Other: GAIT-assisted training

Study type: Interventional

Funder types: Other

Identifiers

NCT06343415

H-23052844

Details and patient eligibility

About

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.

Full 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

Enrollment: 17 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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17 participants in 2 patient groups

GAIT-assisted training

Active Comparator group

Description:

Gait-assisted training in the Lokomat Pro, (Hocoma, Switzerland) for five consecutive days. The Lokomat Pro is a fully automated robotic training device consisting of a treadmill, a body weight support system, two motor-driven leg orthoses, a screen for augmented feedback and a therapist-controlled computer. The orthoses drive the swing phase of the gait, and their guidance force is adjusted between 10-100%. The body weight support can be adjusted between 10-100% of the body weight. The maximum walking speed is 3 km/h, and the cadence of the orthoses is calibrated to the treadmill. The Lokomat has five different emergency and safety stops. Every 5 minutes, an automatic signal reminds the therapist to check in; if not, the Lokomat will automatically stop. Only therapist that has gone through specific education can operate the Lokomat.

Treatment:

Other: GAIT-assisted training

STEP-assisted training

Active Comparator group

Description:

Step-assisted training in the Erigo Pro, (Hocoma, Switzerland) for five consecutive days. The computer-controlled tilt table consists of a verticalization table up to 90° and a choice of cyclic leg movements in three distinct patterns, between 8-80 steps/minute adjustable between 0-100% guidance force. The tilt table can be used with functional electric stimulation (FES). Weight-bearing of the legs is possible between 0-50 kg. The Erigo has one safety stop and an emergency release handle in case of a power failure during operation. Only therapist that has gone through specific introduction can operate the Erigo.

Treatment:

Other: STEP-assisted training