Robot-assisted training for brain injury recovery
Intensive Gait-assisted Versus Intensive Step-assisted Training After Acquired Brain Injury - a Randomised Cross-over Feasibility Trial.
NA · Rigshospitalet, Denmark · NCT06343415
This study is testing two types of robot-assisted training to see if they can help people recovering from brain injuries improve their walking and movement skills.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 17 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Glostrup, Greater Copenhagen) |
| Trial ID | NCT06343415 on ClinicalTrials.gov |
What this trial studies
This feasibility trial investigates two types of intensive robot-assisted training therapies for patients recovering from acquired brain injuries and disorders of consciousness. Participants will be randomly assigned to receive either gait training or step training, followed by a crossover to the alternate training after a brief pause. The study aims to assess the feasibility of the protocol, safety events, physiological measures, and functional outcomes. The trial is conducted in accordance with ethical guidelines and involves patients who are unable to consent, with consent obtained from their next of kin.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are in an unresponsive wakefulness or minimally conscious state following a moderate to severe acquired brain injury.
Not a fit: Patients who are fully conscious or in a confusional state, or those with significant physical restrictions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance rehabilitation outcomes for patients with severe brain injuries.
How similar studies have performed: Other studies have shown promise with robot-assisted rehabilitation approaches, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glostrup, Greater Copenhagen
- Department of brain and spinal cord injury — Glostrup, Greater Copenhagen, Denmark (RECRUITING)
Study contacts
- Study coordinator: Vibeke Wagner, MSc
- Email: vibeke.wagner@regionh.dk
- Phone: +4538631600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acquired Brain Injury, Disorders of Consciousness, Brain injury, Traumatic brain injury, consciousness, robot-assisted gait training, tilt-table, feasibility