ACTRN12620000871943Recruiting未知
Enhancing spontaneous recovery after stroke study (ESPRESSo): A single-site, randomised, controlled, Phase IIa, assessor-blind trial to evaluate the effects of a three week programme of high-intensity, high-dose exploratory arm and hand movements initiated within 1 week of stroke on upper limb motor capacity measured with the Action Research Arm Test..
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- The University of Auckland
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •i.People with monohemispheric ischaemic stroke or intracerebral haemorrhage confirmed by CT or MRI admitted to Auckland City Hospital within the last 7 days
- •ii.First-ever stroke or previous stroke with no upper limb weakness
- •iii.At least 18 years old
- •iv.Received a Good” or Excellent” prediction from the Predict Recovery Potential (PREP2) algorithm
- •v.UE-FM score < 51 at enrolment
- •vi.Able to give informed consent
- •vii.Patients treated with intravenous thrombolysis and/or intra-arterial thrombectomy are eligible
Exclusion Criteria
- •i.UE-FM score > 50 at enrolment
- •ii.Cognition and/or communication impairment precluding informed consent or engagement with the research procedures, as determined by the patient’s clinical team
- •iii.Received a Limited” or Poor” PREP2 prediction
- •iv.Inability to sit in a chair and perform upper limb exercises
- •v.Life expectancy less than 12 months, as determined by the patient’s clinical team
- •vi.Upper limb motor performance limited by pre-existing conditions, such as musculoskeletal disease
- •vii.Residing out of region precluding in-person assessment
- •viii.Social and/or personal circumstances that interfere with the ability to return for therapy sessions and follow up assessments
Investigators
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