A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II

NCT05006261 | Completed Results FDA Device

• 1 other identifier: 2020P002974
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (3)

• Protocol Adherence

  The percentage of Tai Chi home practice sessions completed by participants.

  Post-intervention (approximately 12 weeks)

• Retention

  The percentage of participants who complete the study.

  Through study completion, approximately 12 weeks from the beginning of the study

• System Usability Scale

  The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.

  Post-intervention (approximately 12 weeks)

Other Outcomes (17)

• Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)

  Post-intervention (approximately 12 weeks)

• Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores

  Baseline and post-intervention (approximately 12 weeks)

• Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores

  Baseline and post-intervention (approximately 12 weeks)

Study Arms (1)

Tele-Tai Chi

EXPERIMENTAL

Tele-Tai Chi intervention

Device: Tele-Tai Chi

Interventions

Tele-Tai Chi DEVICE

12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.

Tele-Tai Chi

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 60 and 85 years old
• TC naïve (i.e., never practiced TC)
• Self-reported ability to walk continuously for 15 minutes without an assistive device
• Working email address
• Prior experience with and current access to a computer, smart phone or tablet device

You may not qualify if:

• Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)
• Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study
• Active cancer
• Significant musculoskeletal conditions requiring chronic use of pain medication
• Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score \< 18)

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Results Point of Contact

• Title: Paolo Bonato, PhD
• Organization: Spaulding Rehabilitation Hospital

pbonato@mgh.harvard.edu

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 16, 2021
• Study Start: September 29, 2021
• Primary Completion: October 18, 2023
• Study Completion: October 18, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Locations

US (1)