Acquired Brain InjuryNCT06343415
Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness
A study testing GAIT-assisted training and STEP-assisted training in people with Acquired Brain Injury and Disorders of Consciousness, run by Christina Kruuse at 1 site in Denmark.
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 acquired brain injury and disorders of consciousness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury, Disorders of Consciousness
- What is being tested?
- GAIT-assisted training and STEP-assisted training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Aug 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of brain and spinal cord injury
Glostrup Municipality, Greater Copenhagen, 2600
About this study
Official title: 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.
Read the 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:
- GAIT --> STEP
- STEP --> GAIT
- Conditions
- Acquired Brain Injury, Disorders of Consciousness
- Being tested
- GAIT-assisted training, STEP-assisted training
- Keywords
- Brain injury, Traumatic brain injury, consciousness, robot-assisted gait training, tilt-table, feasibility, cross-over study
- Medical subject headings
- Brain Injuries, Consciousness Disorders, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAIT-assisted trainingOther
Also called Intensive gait-assisted training, Lokomat Pro
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.
STEP-assisted trainingOther
Also called Intensive step-assisted training, Erigo Pro
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: STEP-assisted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 26 days from intervention start
Secondary outcomes (1)
Exploratory Safety Outcomes
Adverse events and reactions are recorded during, between and after interventions (days 1 to 26).
Measured: 26 days from intervention start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start12 Aug 2024
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- AB - BA
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christina Kruuse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christina Kruuse, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Christina Kruuse, Professor, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343415
- Sponsor's protocol ID
- H-23052844
- Status last verified
- Mar 2026
- First submitted
- 14 Mar 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial.
- ClinicalTrials.gov ID
- NCT06343415
- Acronym / sponsor ID
- H-23052844
- Conditions
- Acquired Brain Injury, Disorders of Consciousness
- Keywords
- Brain injury, Traumatic brain injury, consciousness, robot-assisted gait training, tilt-table, feasibility, cross-over study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Christina KruuseUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- GAIT --> STEP
- STEP --> GAIT
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- AB - BA
| Arm | Type | Receives |
|---|---|---|
| GAIT-assisted training | Active comparator | Other: GAIT-assisted trainingGait-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. |
| STEP-assisted training | Active comparator | Other: STEP-assisted trainingStep-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAIT-assisted trainingAlso: Intensive gait-assisted training, Lokomat ProGAIT 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. | Other | GAIT-assisted training |
| STEP-assisted trainingAlso: Intensive step-assisted training, Erigo ProSTEP 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. | Other | STEP-assisted training |
Primary outcome
Inclusion Rate
Time frame: 26 days from intervention start
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.
Completion Ratio of protocols
Time frame: 26 days from intervention start
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.
1 secondary outcome
Exploratory Safety Outcomes
Time frame: 26 days from intervention start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Kruuse, Professor study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GAIT-assisted training and STEP-assisted training in people with Acquired Brain Injury and Disorders of Consciousness, run by Christina Kruuse at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inclusion Rate (time frame: 26 days from intervention start). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.