Search / Trial NCT06233734

Robot-Assisted Gait Training in Early-Subacute Stroke

Launched by UNIVERSITY OF WINCHESTER · Jan 22, 2024

Trial Information

Current as of December 22, 2024

Recruiting

Keywords

Robot Assisted Gait Training Rehabilitation Cardiovascular Health Physical Activity Physiotherapy

ClinConnect Summary

This clinical trial is studying a rehabilitation method called robot-assisted gait training (RAGT) to help people who have had a stroke regain their ability to walk. After a stroke, many patients find it difficult to move around, and this can lead to other health problems. The study uses a robotic device called the Lokomat, which helps patients take steps while they are on a treadmill. Researchers want to see if using this device can improve heart and blood vessel health and encourage more physical activity in stroke patients during their recovery.

To be eligible for this study, participants should have been able to walk independently before their stroke but may need some help now. They must also be stable in terms of their heart and blood pressure, and able to stand for at least 30 minutes. If someone decides to participate, they will receive additional care and support, and all the tests will be safe and non-intrusive. The results from patients using the Lokomat will be compared to those who are receiving standard care without this technology. Ultimately, the goal is to find out if this robotic training can help stroke survivors be more active and improve their overall health.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • 1. Independently mobile (with or without an aid) prior to the stroke
  • 2. FAC (Functional Ambulation Category) score of 0-2 at baseline
  • 3. Cardiovascularly stable as determined by the medical team (heart and blood pressure is stable)
  • 4. Able to tolerate being upright for at least 30 minutes and participate in active therapy
  • Exclusion criteria:
  • 1. If participants have any contraindications related to Lokomat use, as per the manufacturers (Hocoma) guidance. The contraindications in full can be found on the HOCOMA website (https://www.hocoma.com/legal- notes/#lokomatpro_lokomatnanos). The most relevant contraindications are:
  • Any known diagnosis of low bone mineral density - Over 2 metres tall
  • Over 135kg
  • Non-consolidated fractures
  • Any medical condition preventing active rehabilitation (e.g., respiratory disease, pregnancy, neuropsychological conditions)
  • Fixed joint contractures that limit the range of motion of the orthosis - Upper leg length of less than 35cm and more than 47cm
  • Any condition or situation which prohibits the proper adjustment of the harness and/or orthosis (e.g., pregnancy, colostomy bags, skin lesions that cannot be protected appropriately).
  • 2. If patients do not have the capacity to provide informed consent

Trial Officials

James Faulkner, PhD

Principal Investigator

University of Winchester

About University Of Winchester

The University of Winchester is a renowned educational institution committed to advancing knowledge and improving health outcomes through innovative research. As a clinical trial sponsor, the university leverages its academic expertise and multidisciplinary approach to conduct rigorous studies that address critical health challenges. With a focus on ethical standards and participant safety, the University of Winchester fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate research findings into effective interventions, ultimately enhancing patient care and public health.

Locations

Bournemouth, , United Kingdom

Winchester, , United Kingdom

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0