Actively Recruiting

Age: 18Years +
All Genders
NCT06233734

Robot-Assisted Gait Training in Early-Subacute Stroke

Led by University of Winchester · Updated on 2024-05-02

60

Participants Needed

2

Research Sites

30 weeks

Total Duration

On this page

Sponsors

U

University of Winchester

Lead Sponsor

U

University Hospitals Dorset NHS Foundation Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

A stroke happens when blood flow to the brain is cut off. Many people struggle to walk after having a stroke. Regaining the ability to walk is a key aim for many stroke survivors and rehabilitation practitioners as it allows improved independence and better health. This study will assess a rehabilitation method called robot-assisted gait training (RAGT) with stroke patients. RAGT uses a robotic device to assist the patient in taking steps. The RAGT device being investigated in this study is called the Lokomat. This device uses a treadmill, a harness, and a robotic suit to help the user to take steps. In particular, the study will aim to determine whether this form of training can improve the health of the heart and blood vessels (cardiovascular health) of people with stroke. Also, the study will assess whether RAGT helps stroke patients to be more physically active in the initial stages after they have a stroke. Physical activity and cardiovascular health are linked. Physical inactivity, and increased sedentary behaviours, which are both common post-stroke, can lead to worsening cardiovascular health, and increase the risk of another stroke, hence why these are both principal research questions of the study. Patients at one of two NHS inpatient stroke units will be invited to participate in the research - one which uses the Lokomat as standard care and one which does not. The decision to participate (or not) will not result in a change in their care plan, but if they do decide to participate, the research team will collect some additional data to help answer the questions this study is attempting to answer. All the measurements taken will be safe, non-intrusive and pain free. The results of patients using the Lokomat at one stroke unit will be compared to patients in the other inpatient stroke unit not using the device. The investigators expect to see that participants who complete RAGT are more physically active both during and after the RAGT they receive.

CONDITIONS

Official Title

Robot-Assisted Gait Training in Early-Subacute Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Independently mobile (with or without an aid) before the stroke
  • Functional Ambulation Category score between 0 and 2 at baseline
  • Cardiovascularly stable as confirmed by the medical team
  • Able to tolerate being upright for at least 30 minutes and participate in active therapy
Not Eligible

You will not qualify if you...

  • Any contraindications to Lokomat use as per manufacturer guidance, including low bone mineral density, height over 2 metres, weight over 135kg, non-healed fractures, fixed joint contractures limiting orthosis use, or conditions preventing proper harness adjustment such as pregnancy or skin lesions
  • Any medical condition preventing active rehabilitation, including respiratory disease or neuropsychological conditions
  • Inability to provide informed consent

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

Actively Recruiting

2

Royal Hampshire County Hospital

Winchester, United Kingdom, SO22 5DG

Not Yet Recruiting

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Research Team

J

James Faulkner, PhD

CONTACT

A

Andrew Reid, MRes

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Robot-Assisted Gait Training in Early-Subacute Stroke | DecenTrialz