Stroke Circulatory System Stroke, not specified as haemorrhage or infarction
Conditions
Interventions
Active group:
iPAM will be set up by the patient's treating therapist to deliver upper limb exercises based on clinical assessment. iPAM, uses a computer screen [Patient User Interface] to present ta
this is the 'patient workspace'. The patient's movement is assisted at the upper arm and forearm by the iPAM system in three dimensions, simulating a therapist's hands. iPAM delivers assistance accord
Sponsors
University of Leeds (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. New clinically diagnosed ischaemic or haemorrhagic stroke (excluding subarachnoid haemorrhage) in the 1-6 weeks prior to randomisation 3. Reduced arm movement due to stroke - Patient unable to turn palm face up and face down, keeping elbow straight, thumb pointing up and shoulder flexed between 30° and 90° 4. Expected to need ongoing in-patient rehabilitation treatment for at least 3 - 6 weeks after stroke (clinical judgement) 5. Expected to be able to comply with treatment schedule post randomisation 6. Able to sit safely in supportive wheelchair with harness for 30-60 minutes 7. Able to participate in an assisted upper limb exercise session at least 10 minutes 8. Able to summon help and able to press the patient stop button on the iPAM system wheelchair with the non paretic arm
Exclusion criteria
Exclusion criteria: 1. Not expected to survive for 2 months following stroke 2. Medically unstable (e.g. cardiac or respiratory conditions or epilepsy) 3. Could not use the arm affected by stroke prior to stroke (e.g. because of other conditions) 4. Weight over 125kg (19 stone 9.6lbs / 275.6lbs) (weight restrictions on the orthoses and seating system for iPAM)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl Meyer (Upper limb section) change score from baseline to 10 weeks post randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of subjects showing a clinically meaningful response (defined as >=3 point improvement in Fugl Meyer upper limb score; Barthel Index; Stroke Impact Scale; ABILHAND; EQ-5D 2. Safety: Safety issues will be reported by the treating therapist to the recruiting centre Principal Investigator according to MHRA processes. 3. Implementation outcomes: Standardised Likert response questionnaire will be used. Questions include ease of implementation, nature of exercise, fit with routine clinical service | — |
Countries
United Kingdom
Outcome results
None listed