Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness
NCT ID: NCT06343415
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
17 participants
INTERVENTIONAL
2024-08-12
2025-07-31
Brief Summary
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* 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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
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.
Study Groups
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GAIT-assisted training
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.
GAIT-assisted training
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 training
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.
STEP-assisted training
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.
Interventions
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GAIT-assisted training
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 training
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Christina Kruuse
OTHER
Responsible Party
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Christina Kruuse
Professor, Dr Med
Principal Investigators
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Christina Kruuse, Professor
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Locations
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Department of brain and spinal cord injury
Glostrup Municipality, Greater Copenhagen, Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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H-23052844
Identifier Type: -
Identifier Source: org_study_id
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