A randomised controlled feasibility study to investigate the effects of a functional standing frame programme versus usual physiotherapy in people with severe sub-acute stroke on function, quality of life and neuromuscular impairment

Royal Cornwall Hospitals NHS Trust0 sites45 target enrollmentDecember 19, 2016

Overview

Registry

who.int

Start Date

December 19, 2016

End Date

March 31, 2019

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

•1\. New (first/recurrent) clinical diagnosis of stroke, cerebral haemorrhage or infarct confirmed by consultant or CT scan leading to admission to the SRU
•2\. Aged 18 years and over
•3\. Graded as mRS 4 or 5 and/or NIHSS\=16 (severe or very severe stroke and unable to stand without support/mechanical aid and assistance of two people)
•4\. Able to give informed consent or assent from a consultee
•5\. Conscious and responsive to verbal commands

•1\. Systolic blood pressure \=100mmHg or \=220mmHg at rest lying or sitting
•2\. Oxygen saturation \=87% with or without supplementary oxygen (e.g. severe acute/chronic cardiorespiratory disease)
•3\. Resting heart rate of \=40 or \=110 beats per minute (e.g. cardiovascular instability)
•4\. Temperature \=38\.5 degrees centigrade or \=35 degrees centigrade
•5\. Orthopaedic impairments which prevent full weight bearing in standing
•6\. Malnutrition Universal Screening Tool score of \=2, or not meeting nutritional demands for therapeutic interventions
•7\. Documented clinical decision for receiving end of life care
•8\. Unstable coronary or other medical condition that is judged by the PI/CI or clinical team to impose a medical risk to the patient by involvement in the study
•9\. Severe communication and/or cognitive deficit which affects their ability to follow instructions (e.g. assessed functionally by specialist clinicians as being a risk to themselves or others due to their inability to follow non\-verbal prompts or are behaving erratically)
•10\. Immobile and not weight bearing pre\-stroke