Robot-Assisted Gait Training in Early-Subacute Stroke

NCT06233734 | Recruiting FDA Device

• 1 other identifier: Faulkner_Lokomat_23
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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

Stroke

Keywords

Robot assisted gait training; Rehabilitation; Cardiovascular health; Physical activity; Physiotherapy

Outcome Measures

Primary Outcomes (1)

• Pulse wave velocity (carotid-femoral)

  The change in pulse wave velocity (carotid-femoral pulse wave velocity) over the first three months post-stroke

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

Secondary Outcomes (13)

• Central blood pressure

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

• Peripheral blood pressure

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

• Pulse wave velocity (brachial-ankle)

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

• Step count

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

• Number of sit to stand transitions

  All measures will be taken at: baseline (at enrolment into study, soon after stroke onset); 2 weeks post-enrolment; 4 weeks post-enrolment; 6 weeks post-enrolment; and 3-months post-enrolment)

Study Arms (2)

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.

Device: The Lokomat (Hocoma, Zurich, Switzerland).

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.

Interventions

The Lokomat (Hocoma, Zurich, Switzerland). DEVICE

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.

Robot Assisted Gait Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from two acute stroke wards at two different UK NHS hospitals. Therefore every participant recruited will be an inpatient at a hospital following a stroke. The two hospitals are: Royal Bournemouth Hospital (University Hospitals Dorset NHS Foundation Trust) and Royal Hampshire County Hospital (Hampshire Hospitals NHS Foundation Trust).

You may qualify if:

• 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

You may not qualify if:

• 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).
• If patients do not have the capacity to provide informed consent

Sponsors & Collaborators

• University of Winchester: lead
• University Hospitals Dorset NHS Foundation Trust: collaborator
• Hampshire Hospitals NHS Foundation Trust: collaborator

Study Sites (2)

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

RECRUITING

Royal Hampshire County Hospital

Winchester, SO22 5DG, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• James Faulkner, PhD

  University of Winchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Faulkner, PhD

CONTACT

01962624932; James.Faulkner@winchester.ac.uk

Andrew Reid, MRes

CONTACT

01962624932; a.reid.18@unimail.winchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: January 31, 2024
• Study Start: April 30, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)