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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Independently mobile (with or without an aid) prior to the stroke

• FAC (Functional Ambulation Category) score of 0-2 at baseline

• Cardiovascularly stable as determined by the medical team (heart and blood pressure is stable)

• Able to tolerate being upright for at least 30 minutes and participate in active therapy

Locations
Other Locations
United Kingdom
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Royal Hampshire County Hospital
NOT_YET_RECRUITING
Winchester
Contact Information
Primary
James Faulkner, PhD
James.Faulkner@winchester.ac.uk
01962624932
Backup
Andrew Reid, MRes
a.reid.18@unimail.winchester.ac.uk
01962624932
Time Frame
Start Date: 2024-04-30
Estimated Completion Date: 2024-12
Participants
Target number of participants: 60
Treatments
Robot Assisted Gait Training
This group of stroke patients will receive their standard care. For these participants, at this site (University Hospitals Dorset NHS Foundation Trust), this includes robot-assisted gait training.
Conventional care
This group of stroke patients will receive their standard care. For these participants, at this site (Hampshire Hospitals NHS Foundation Trust), this does not include any robot-assisted gait training.
Related Therapeutic Areas
Sponsors
Leads: University of Winchester
Collaborators: Hampshire Hospitals NHS Foundation Trust, University Hospitals Dorset NHS Foundation Trust

This content was sourced from clinicaltrials.gov