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:
- 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 criteria:
-
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
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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1
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
2
Royal Hampshire County Hospital
Winchester, United Kingdom, SO22 5DG