Robot-assisted Training After Acquired Brain Injury and Disorders of Consciousness
Launched by CHRISTINA KRUUSE · Mar 27, 2024
Trial Information
Current as of July 23, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring two types of robot-assisted training designed for patients recovering from brain injuries or experiencing disorders of consciousness. The main goal is to see if these training methods are practical and safe for people during their early rehabilitation. Participants will be randomly assigned to receive either a week of training focused on walking (called gait training) followed by a week of step training, or the other way around. Throughout the study, researchers will monitor safety, physical activity levels, and improvements in daily functioning.
To participate, individuals must be at least 18 years old, currently receiving rehabilitation for a moderate to severe brain injury, and in a state where they are unresponsive or minimally aware. They need to have consent from a family member or legal guardian. Participants can expect to engage in intensive training sessions using robotic equipment, and the trial aims to gather valuable information on how these therapies can aid recovery. It's important to note that certain health conditions, like severe osteoporosis or specific injuries, may prevent someone from joining the study.
Gender
ALL
Eligibility criteria
- • 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)
- • 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
About Christina Kruuse
Christina Kruuse is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through rigorous and innovative clinical studies. With a focus on ethical standards and regulatory compliance, Christina Kruuse collaborates with a diverse range of stakeholders, including healthcare professionals, researchers, and patient advocacy groups, to design and implement trials that address unmet medical needs. Leveraging a wealth of experience in clinical development, Christina Kruuse aims to facilitate the discovery of safe and effective therapies while prioritizing participant safety and data integrity throughout the research process.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Glostrup, Greater Copenhagen, Denmark
Patients applied
Trial Officials
Christina Kruuse, Professor
Study Director
Rigshospitalet, Denmark
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported