Robot-assisted training to help stroke patients walk again

The Effect of Robot-assisted Gait Training on Cardiovascular Health and Activity Levels Within Early-subacute Stroke Patients

This study is testing if using a robot to help stroke patients practice walking can improve their walking ability and heart health compared to those who don’t use the robot.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Winchester (other)
• Locations: 2 sites (Bournemouth and 1 other locations)
• Trial ID: NCT06233734 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of robot-assisted gait training (RAGT) using the Lokomat device for stroke patients in the early subacute phase. It involves monitoring the physical activity and cardiovascular health of patients receiving RAGT at Royal Bournemouth Hospital and comparing them to matched patients at Royal Hampshire County Hospital who do not receive this intervention. The study aims to determine if RAGT can enhance walking ability and improve cardiovascular health in stroke survivors. Participants will be assessed based on their Functional Ambulation Category score, blood pressure, and age.

Who should consider this trial

Good fit: Ideal candidates are stroke patients who were independently mobile before their stroke and have a Functional Ambulation Category score of 0-2.

Not a fit: Patients with contraindications to Lokomat use or those unable to participate in active rehabilitation may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve walking ability and cardiovascular health in stroke patients, leading to enhanced independence.

How similar studies have performed: Previous studies have shown promising results with robot-assisted gait training, indicating potential benefits for stroke rehabilitation.

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

Where this trial is running

Bournemouth and 1 other locations

• Royal Bournemouth Hospital — Bournemouth, United Kingdom (RECRUITING)
• Royal Hampshire County Hospital — Winchester, United Kingdom (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: James Faulkner, PhD — University of Winchester
• Study coordinator: James Faulkner, PhD

Conditions: Stroke, Robot assisted gait training, Rehabilitation, Cardiovascular health, Physical activity, Physiotherapy