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

Traumatic Brain Injury Clinical Trial

Official title:

Intensive Gait-assisted Versus Intensive Step-assisted Training After Traumatic Brain Injury - a Randomised Cross-over Feasibility Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343415
• Other study ID #: H-23052844
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2024
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Rigshospitalet, Denmark
• Contact: Vibeke Wagner, MSc
• Phone: +4538631600
• Email: vibeke.wagner[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: July 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Traumatic brain injury (ICD 10, DS06)
• 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
• 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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Consciousness Disorders
• Disorders of Consciousness
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Denmark	Department of brain and spinal cord injury	Glostrup	Greater Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Christina Kruuse

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disability Rating Scale (DRS)	The DRS assesses the overall disability in patients with traumatic brain injury in 8 functional areas in 4 categories. The scores range between 0 (no disability) to 29 (extreme vegetative state). A clinician performs the test, which requires no specific training, and takes about 15 minutes or can be done by interviewing staff or relatives. The assessment is blinded for allocation.	26 days from intervention start
Other	Coma Recovery Scale-Revised (CRS-R) and level of consciousness	The CRS-R assesses the level of consciousness in patients with acquired brain injury and is used for monitoring the course of recovery. It consists of 6 subscales, and the scoring is based on specific behavioural responses to standardised sensory stimuli at the bedside. The minimum score is 0 (reflexive activity), and the maximum score is 23 (cognitively mediated behaviour). A trained clinician performs the test, which takes 15-30 minutes to administer. The CRS-R has a high sensitivity for detecting signs of consciousness and includes criteria for both minimally conscious state and emergence, plus and minus. A score of 10 or greater indicates a minimally conscious state or the emergence minimally conscious state. A trained neuropsychologist blinded for allocation performs the CRS-R.	26 days from intervention start
Other	Early Functional Abilities (EFA)	The EFA assesses the functional status in the early stages of recovery after acquired brain injury. It comprises 20 items in 5 subscales rated on a 5-point ordinal scale. The minimum score is 20 (no function), and the maximum score is 100 (normal function). The EFA has been shown to have a ceiling effect with better functioning. The scoring is based on observations within the last 72 hours and takes 15-30 minutes to administer. The patient's team administers the EFA why assessment is not blinded to allocation.	26 days from intervention start
Other	Functional Independence Measure (FIM)	The FIM assesses the severity of disability in rehabilitation patients and how much assistance is required for an individual to perform activities of daily living. It consists of 18 items (13 motor tasks and five cognitive tasks) rated on a 7-point ordinal scale. Scores range from 18 (totally dependent) to 126 (completely independent). The FIM has some floor effects in patients with low function. The scoring is based on observations within the last 72 hours and takes 15-30 minutes to perform the scale. The patient's team administers the FIM why assessment is not blinded to allocation.	26 days from intervention start
Other	Physical activity intensity	The investigators explore if GAIT and STEP induce a cardiovascular response resembling physical activity, even though muscular activity might be absent. The percentage of heart rate max (HRmax) is used as an indicator of physical activity intensity.; HRmax is calculated from the following formulas: Female: HRmax = 209.273 - 0.803 x age (R2 = 0.55) Male: HRmax = 208.609 - 0.716 x age (R2 = 0.47); "Physical activity intensity" is reported using the following cut-offs for physical activity levels: Light intensity: < 65% of HRmax. Moderate intensity: 65-75% of HRmax. Vigorous intensity: 76-96% of HRmax.; In addition, the time (minutes) spent in light, moderate, or vigorous physical activity is explored.	during intervention period (10 days) during training sessions
Other	Mean arterial pressure (MAP)	The mean arterial pressure is, among others, regulated by the baroreceptors. It is explored how blood pressure regulates after GAIT and STEP. Continuous non-invasive arterial pressure (CNAP) and MAP are measured in a resting position before GAIT/STEP preparation. The investigators measure CNAP and MAP after the training session when the patient is positioned in a resting position (sitting or lying.)	during intervention period (10 days), after training sessions
Other	Heart Rate Variability (HRV)	The HRV is suggested to reflect responsiveness in patients with disorders of consciousness indirectly. HRV might reflect the interaction between the autonomic nervous system and cognitive, sensory, behavioural, and affective processes. The HRV is also an indirect measure of the sympathetic/parasympathetic balance. The HRV signal is obtained from the heart rate measures; the high frequency (HF) interval reflects parasympathetic activity (0.15-0.5Hz; HF); the low-frequency (LF) interval reflects mainly sympathetic but also parasympathetic activity (0.04-0.015 Hz; LF) and is typically correlated to physical stress; The LF/HF is classically considered an index of "sympathetic- vagal balance" of heart rate regulation, particularly during long-term recordings and is thus classically an expression of the baroreceptor feedback loop. It is expected that the interventions stimulate patient awakeness and awareness, which might be reflected in a change in HRV.	during intervention period (10 days), end of intervention
Other	Behavioural Outcome	It is investigated if behavior differ between interventions. Behavior can be either random/not goal oriented, or a response/goal oriented to an input. This is evaluated from video recordings from the first and last session of each intervention where behavior like communication, visual awareness, and motor output are analysed.; Behavioural changes are explored from observations not blinded to allocation.	First and last session of each arm (30 minutes, 4 sessions per participant)
Primary	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
Primary	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	Exploratory Safety Outcomes	Adverse events and reactions are recorded during, between and after interventions (days 1 to 26).	26 days from intervention start