RecruitingNCT06233734

Robot-Assisted Gait Training in Early-Subacute Stroke

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


Sponsor

University of Winchester

Enrollment

60 participants

Start Date

Apr 30, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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

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Interventions

DEVICEThe 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.


Locations(2)

Royal Bournemouth Hospital

Bournemouth, United Kingdom

Royal Hampshire County Hospital

Winchester, United Kingdom

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NCT06233734


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