Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-01-11 @ 11:55 PM
Study NCT ID:
NCT06758505
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Rehabilitation Strategies for Social Participation in Chronic Stroke Survivors
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START2ACT
Brief Summary:
The goal of this clinical trial is to test a new rehabilitation program, combining acceptance and commitment therapy with strategy training (ACES), to help people resume social participation after stroke and live in the community.
Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ACES report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to the existing rehabilitation program using strategy training alone (START).
Participants will:
* complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life
* be randomized to receive either ACES or START rehabilitation program for 10 sessions at their home
* repeat part of the tests at the end of the intervention and one month after
Investigators will also compare the changes in social participation and psychological flexibility from baseline to follow-up at one-month after rehabilitation to see if participants who receive ACES report clinically meaningful improvements (Cohen's d=0.2 or greater) compared to the existing rehabilitation program using strategy training alone (START).
Participants will:
* complete testing to see if they are eligible for the study. If qualified, complete testing to understand how the stroke has affected their daily life
* be randomized to receive either ACES or START rehabilitation program for 10 sessions at their home
* repeat part of the tests at the end of the intervention and one month after
Detailed Description:
In April 2025, the investigator changed the recruitment status because the first enrolled participant ended up being ineligible. The investigators also updated eligibility criteria and outcome measures to be consistent with the IRB protocol.
In June 2025, the investigator received notice of award from NIH and thus updated information to be consistent with the IRB protocol.
In June 2025, the investigator received notice of award from NIH and thus updated information to be consistent with the IRB protocol.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R03HD114635 | NIH | None | https://reporter.nih.gov/quic… | View |