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Search / Trial NCT06343415

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

Brain Injury Traumatic Brain Injury Consciousness Robot Assisted Gait Training Tilt Table Feasibility Cross Over Study

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.

Locations

Glostrup, Greater Copenhagen, Denmark

Patients applied

0 patients applied

Trial Officials

Christina Kruuse, Professor

Study Director

Rigshospitalet, Denmark

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported