Ignite Creation Date:
2025-12-24 @ 12:34 PM
Ignite Modification Date:
2025-12-30 @ 4:45 AM
Study NCT ID:
NCT05006261
Status:
COMPLETED
Last Update Posted:
2024-12-10
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
Sponsor:
Spaulding Rehabilitation Hospital
Organization:
Study Overview
Official Title:
A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
Status:
COMPLETED
Status Verified Date:
2024-11
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:
None
Brief Summary:
This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.
Detailed Description:
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naìˆve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency.
Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).
Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.
Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).
Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: