Status:

RECRUITING

Robot-Assisted Gait Training in Early-Subacute Stroke

Lead Sponsor:

University of Winchester

Collaborating Sponsors:

University Hospitals Dorset NHS Foundation Trust

Hampshire Hospitals NHS Foundation Trust

Conditions:

Stroke

Eligibility:

All Genders

18+ years

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 pr...

Detailed Description

The design of the study This study will be a retrospective-matched non-randomised trial. The physical activity and cardiovascular health of stroke patients using the Lokomat at an inpatient stroke un...

Eligibility Criteria

Inclusion criteria:

  1. Independently mobile (with or without an aid) prior to the stroke
  2. FAC (Functional Ambulation Category) score of 0-2 at baseline
  3. Cardiovascularly stable as determined by the medical team (heart and blood pressure is stable)
  4. Able to tolerate being upright for at least 30 minutes and participate in active therapy

Exclusion criteria:

  1. 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).
  2. If patients do not have the capacity to provide informed consent

Key Trial Info

Start Date :

April 30 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

December 1 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06233734

Start Date

April 30 2024

End Date

December 1 2024

Last Update

May 2 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Royal Bournemouth Hospital

Bournemouth, United Kingdom, BH7 7DW

2

Royal Hampshire County Hospital

Winchester, United Kingdom, SO22 5DG