ACTRN12620000105943Terminated未知
Support After Stroke with group-based classeS: The SASS study: Phase II randomised controlled trial assessing the underlying changes to the brain
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Sponsor
- Monash University
- Enrollment
- 38
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
- •Aged 18 years or more
- •Confirmed diagnosis of stroke whereby the last stroke event is between 3 and 12 months
- •Participants living in the community (not nursing home or aged care residential facilities) within 30 kms of BrainPark (770 Blackburn Rd, Clayton VIC 3168, Australia)
- •Have access to email and/or SMS (to access home practice guide, and receive class reminders)
- •Self-identify as users of electronic technology such as CD player (to access home practice guide)
- •Have a baseline Modified Rankin Score of 0 (i.e. no disability) to 4 (i.e. may require some assistance but not constant care);
- •Able to give informed written consent and can understand two-step verbal commands; already enrolled in other clinical trial, as long as there will be no issues with contamination to either trial, and that there is assurance that responder burden is minimal
Exclusion Criteria
- •Participants will be excluded if:
- •Undertaking a mindfulness program (meditation, Tai Chi, yoga) or have done these regularly (e.g. monthly in frequency) in the 12 months prior to stroke
- •Cannot verbally communicate in English. Due to constraints of our budget, translation of yoga intervention delivery by experts into other languages will not be possible
- •Have significant language or communication impairments that will restrict the ability to participate
- •Poor prognosis (unlikely to survive to 12 weeks following randomisation)
- •Presence of contraindications to MRI (e.g. metallic or electronic implants not known to be safe)
- •Suffer from claustrophobia (i.e. inability to be in MRI scans where space is constraint)
Investigators
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