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

NCT06343415 | Completed

• 1 other identifier: H-23052844
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Acquired Brain Injury; Disorders of Consciousness

Keywords

Brain injury; Traumatic brain injury; consciousness; robot-assisted gait training; tilt-table; feasibility; cross-over study

Outcome Measures

Primary Outcomes (2)

• Inclusion Rate

  To be deemed feasible, the inclusion rate must be 70% (12 out of 17 eligible patients), with a 95% confidence interval (CI) from 46.9% to 86.7%. The data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.

  26 days from intervention start

• Completion Ratio of protocols

  To be deemed feasible, the ratio of completed sessions must be 80% (68 out of 85 sessions per group) with a 95% CI from 70.3% to 87.1%. The data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.

  26 days from intervention start

Secondary Outcomes (1)

• Exploratory Safety Outcomes

  26 days from intervention start

Other Outcomes (8)

• Disability Rating Scale (DRS)

  26 days from intervention start

• Coma Recovery Scale-Revised (CRS-R) and level of consciousness

  26 days from intervention start

• Early Functional Abilities (EFA)

  26 days from intervention start

Study Arms (2)

GAIT-assisted training

ACTIVE COMPARATOR

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.

Other: GAIT-assisted training

STEP-assisted training

ACTIVE COMPARATOR

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.

Other: STEP-assisted training

Interventions

STEP-assisted training OTHER

STEP duration starts when stepping and elevation are started. The participant will step as intensively as possible within prespecified safety limits. Intensity is considered the most important factor for the feasibility outcome of the completion ratio and for the safety outcomes. Intensity encompasses duration and repetitions. Duration: 10 minutes is considered the minimum acceptable duration for a session to be deemed complete and 30 minutes as the maximum duration for a training session. Repetitions: A step intensity of approximately 1000 steps per session is considered as high intensity and training aims to reach this amount. This is based on neuroplasticity theories. Step cadence starts at 40 steps/minute and cadence is adjusted accordingly. The leg loading starts a 5 kg and is, if possible, increased to a maximum of 40% of total body weight while adjusting knee extension to ≤10 degrees flexion in stance. The guidance force is kept at 100% and symmetric in all sessions.

Also known as: Intensive step-assisted training, Erigo Pro

STEP-assisted training

GAIT-assisted training OTHER

GAIT duration starts when walking is started. The participant will walk as intensively as possible within prespecified safety limits. Intensity is considered the most important factor for the feasibility outcome of the completion ratio and for the safety outcomes. Intensity encompasses duration and repetitions. Duration: 10 minutes is considered the minimum acceptable duration for a session to be deemed complete and 30 minutes as the maximum duration for a training session. Repetitions: A step intensity of approximately 1000 steps per session is considered as high intensity and training aims to reach this amount. This is based on neuroplasticity theories. Speed starts at 1 km/h and is adjusted accordingly. The body weight support (BWS) is kept between 60-100% of total body weight. The BWS is adjusted so the knee flexion in the stance phase does not exceed 10 degrees. The guidance force is kept at 100% and symmetric in all sessions.

Also known as: Intensive gait-assisted training, Lokomat Pro

GAIT-assisted training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Christina Kruuse: lead

Study Sites (1)

Department of brain and spinal cord injury

Glostrup Municipality, Greater Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Brain Injuries; Consciousness Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Christina Kruuse, Professor

  Rigshospitalet, Denmark

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Assessors are blinded to allocation for the following exploratory clinical outcome scales: "Disability Rating Scale" and "Coma Recovery Scale-Revised". Data analyses are blinded by coding and blinding the groups (groups A and B) for the statistical analyses. After the analysis, two separate conclusions will be written before lifting the blinding and revealing the results.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Dr Med

Model Details: AB - BA

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: August 12, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

DK (1)