Acquired Brain Injury, Disorders of Consciousness
Conditions
Keywords
Brain injury, Traumatic brain injury, consciousness, robot-assisted gait training, tilt-table, feasibility, cross-over study
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.
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: 1. GAIT --\> STEP 2. STEP --\> GAIT
Interventions
OTHERGAIT-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.
OTHERSTEP-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.
Sponsors
Christina Kruuse
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Masking description
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.
Intervention model description
AB - BA
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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). * 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.
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inclusion Rate | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exploratory Safety Outcomes | 26 days from intervention start | Adverse events and reactions are recorded during, between and after interventions (days 1 to 26). |
Countries
Denmark
Contacts
STUDY_DIRECTORChristina Kruuse, Professor
Rigshospitalet, Denmark
Outcome results
None listed