protocolSection identificationModule nctId: NCT06343415, orgStudyIdInfo id: H-23052844, briefTitle: Robot-assisted Training After Traumatic Brain Injury and Disorders of Consciousness, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-16, primaryCompletionDateStruct date: 2025-04-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Christina Kruuse, class: OTHER, descriptionModule briefSummary: The goal of this randomised cross-over feasibility trial is to investigate two intensive robot-assisted training therapies in the early rehabilitation phase after traumatic 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., conditionsModule conditions: Traumatic Brain Injury, conditions: Disorders of Consciousness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: AB - BA, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: 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., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 17, type: ESTIMATED, armsInterventionsModule interventions name: GAIT-assisted training, interventions name: STEP-assisted training, outcomesModule primaryOutcomes measure: Inclusion Rate, primaryOutcomes measure: Completion Ratio of protocols, secondaryOutcomes measure: Exploratory Safety Outcomes, otherOutcomes measure: Disability Rating Scale (DRS), otherOutcomes measure: Coma Recovery Scale-Revised (CRS-R) and level of consciousness, otherOutcomes measure: Early Functional Abilities (EFA), otherOutcomes measure: Functional Independence Measure (FIM), otherOutcomes measure: Physical activity intensity, otherOutcomes measure: Mean arterial pressure (MAP), otherOutcomes measure: Heart Rate Variability (HRV), otherOutcomes measure: Behavioural Outcome, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of brain and spinal cord injury, status: RECRUITING, city: Glostrup, state: Greater Copenhagen, zip: 2600, country: Denmark, contacts name: Christina Kruuse, Professor, role: CONTACT, email: christina.kruuse@regionh.dk, contacts name: Vibeke Wagner, MSc, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 55.6666, lon: 12.40377, hasResults: False