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Robot-Assisted Gait Training in Early-Subacute Stroke

NCT06233734 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2024-05-02

No results posted yet for this study

Summary

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

Interventions

DEVICE

The Lokomat (Hocoma, Zurich, Switzerland).

The Lokomat is a device which can be used to implement robot-assisted gait training safely within disabled stroke populations. The robot-assisted gait training group will receive training via the Lokomat. Involvement in the study will not influence the duration or frequency of robot-assisted gait training sessions they receive. The amount of training they receive via the Lokomat will be determined (as per standard care) by the care team at the stroke ward.

Sponsors & Collaborators

  • University Hospitals Dorset NHS Foundation Trust

    collaborator OTHER_GOV

  • Hampshire Hospitals NHS Foundation Trust

    collaborator OTHER

  • University of Winchester

    lead OTHER

Principal Investigators

  • James Faulkner, PhD · University of Winchester

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06233734 on ClinicalTrials.gov