Support After Stroke with group-based classeS: The SASS study

Not Applicable

• Conditions: Stroke; Stroke - Ischaemic; Stroke - Haemorrhagic

• Registration Number: ACTRN12620000105943
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-05
• Study Completion: 2023-12-01
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 38

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite primary: Changes in brain structure (i.e., cortical thickness, resting-state connectivity, structural connectivity and cerebral blood flow) assessed using Magnetic Resonance Imaging (MRI) brain scans. [ Baseline, and at 12 weeks after intervention commencement (~13 weeks) ]