None listed
Conditions
Brief summary
The purpose of this partnership project is to address a significant evidence-to-practice gap by implementing and evaluating a new model of care for stroke rehabilitation, using mechanobiology-based, robot-assisted weight-bearing exercise with biofeedback to improve bone health in patients following an acute stroke. Hypothesis:: Relative to standard care, the new model of care for stroke patients utilising a mechanobiology-based robot-assisted weight-bearing exercise will achieve significant and sustainable improvements in bone health consistent with that recommended by the 2017 clinical guidelines for stroke management. This project will provide the necessary comparative-effectiveness ‘proof-of-concept’ evidence for the use of robots in clinical practice to inform rehabilitation policy.
Interventions
A new model of care for stroke rehabilitation, using mechanobiology-based, robot-assisted weight-bearing exercise with biofeedback to improve bone health in patients following an acute stroke
a) Robot-assisted exercise: The robot can provide physical support of lower limbs during sit-to-stand and stand-to-sit transfers. With waist, knees and feet firmly fastened and protected, the patients can perform sit-to-stand exercise.
b) During sit-to-stand exercise, the biofeedback device compares the fo
A new model of care for stroke rehabilitation, using mechanobiology-based, robot-assisted weight-bearing exercise with biofeedback to improve bone health in patients following an acute stroke a) Robot-assisted exercise: The robot can provide physical support of lower limbs during sit-to-stand and stand-to-sit transfers. With waist, knees and feet firmly fastened and protected, the patients can perform sit-to-stand exercise. b) During sit-to-stand exercise, the biofeedback device compares the foot reaction force with two preset thresholds and emits audible feedback tones to guide the patient in maintaining certain speed of sit-to-stand which results in the load within the predicted lower threshold and upper threshold c) & d) Robot-assisted weight-bearing exercise commenced within one month of stroke for a period of 12 months (three training sessions weekly for the first three months and one training session weekly for the remaining 9 months). Each sit-to-stand training session lasts up to 60 mins with a minimum of 6 sets (15 repetitions per set with 3 mins rest between sets) e) The mode of administration: group of 4 f) Supervision: physiotherapist & research assistant g) At the time point of three month, the feasibility and safety of the intervention will be assessed. h) Monitor adherence to the intervention: attendance check lists and reminder text messages
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(1) age >=18 years old, (2) first ever stroke, (3) hospital admission <2 weeks post stroke and (4) Functional Independence Measure scores of 1–4 (total dependence) on both the locomotor and transfer items at time of admission.
Exclusion criteria
(1) survival expected to be >=12 months, (2) a cerebellar, bilateral or brainstem stroke that makes it unsafe to operate the robotic device, (3) unable to understand two-part commands due to language or cognitive deficits, (4) neuromuscular condition other than stroke (e.g. Parkinson’s disease or multiple sclerosis), (5) orthopaedic limitations (e.g. severe lower extremity contractures, primary fragility fractures or moderate to severe osteoporosis), (6) bilateral upper limb motor impairment post stroke, (7) hip replacement history, (8) any condition that precludes participation in weight-bearing exercises.
Outcome results
None listed