Virtual Reality-based Mindful Movement Therapy for Seniors

NCT06334328 | Completed

• 1 other identifier: 2205009237
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The current proposal aims to 1) develop a technical platform and implementation plan for the delivery of a virtual reality-based mindful movement therapy (VR-MMT) protocol for older adults; and 2) conduct a clinical trial to examine the feasibility and preliminary efficacy of an 8-week, 16-session module VR-MMT intervention for this population. The findings of this study will help us to identify engagement barriers and refine the intervention contents as well as the study protocol necessary for the preparation of grant applications to conduct a controlled clinical trial. This study is innovative and high impact as this is the first study to examine the feasibility and preliminary efficacy of a VR-MMT intervention that could potentially ameliorate cognitive and mobility decline and promote psychological wellbeing in older adults by combining a widely accessible technology and creative embodiment-based approach.

Conditions

Cognitive Decline; Physical Activity; Psychological Wellbeing

Outcome Measures

Primary Outcomes (5)

• Treatment adherence

  We will log participants' session attendance to track treatment adherence

  Throughout the intervention (week 1-week 6)

• Treatment acceptability

  Treatment Evaluation Inventory Short Form (post-intervention only) is a 9-item measure of the perceived acceptability of behavioral treatments. Items are rated on a 5-point scale with the anchor points 1 (strongly disagree) and 5 (strongly agree). Higher score meaning greater levels of treatment acceptability.

  Post intervention (Week 6)

• Treatment satisfaction

  Usefulness, Satisfaction, and Ease of Use Questionnaire (post-intervention only) is a 30-item instrument that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. Each question is rated on a seven-point scale with the anchor points 1 (strongly disagree) and 7 (strongly agree). There are also two open-ended response questions asking the user to list the most negative aspects and the most positive aspects. All items are summed to give a total score, with higher scores indicating greater usability.

  Post intervention (Week 6)

• Qualitative feedback

  A semi-guided individual interview (30 min) will be conducted upon the completion of the intervention to learn about participants' experience of participating in the study, perceived benefits, perceived barriers, and suggestions for improvement.

  Post intervention (within 1-2 weeks after the conclusion of the 6-week intervention)

• Safety

  We will log adverse event to assess safety of the intervention

  Throughout the intervention (week 1-week 6)

Secondary Outcomes (7)

• Montreal Cognitive Assessment (MoCA)

  Pre and post intervention (Week 0 and Week 6)

• Trail making test

  Pre and post intervention(Week 0 and Week 6)

• The Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

  Pre and post intervention(Week 0 and Week 6)

• Physical Activity Scale for the Elderly (PASE)

  Pre and post intervention(Week 0 and Week 6)

• Physical Performance Battery (SPPB)

  Pre and post intervention(Week 0 and Week 6)

Study Arms (1)

Virtual reality based mindful movement therapy

EXPERIMENTAL

Participants will be asked to complete 12 VR-MMT sessions over a 6-week period, with two 30-minute sessions per week. Each session will be comprised of a guided warm-up (5 min, pre-recorded video played on the computer monitor) followed by a VR module with a head-mounted display (HMD) on (20 min). The VR module includes both structured and freestyle dance/movement guided by the therapist's prompts that are pre-recorded. Sessions will end with a closing routine (5 min, including guided breathing, stretching, and meditation) in order to assist participants to transition back to the real environment.

Behavioral: Virtual reality based mindful movement therapy

Interventions

Virtual reality based mindful movement therapy BEHAVIORAL

VR-MMT combines VR games, multisensory and cognitive stimulation, hand-eye and full body coordination, creative processes, expressive movement, mindfulness practice, and social connectedness.

Virtual reality based mindful movement therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Subjects must be age 65 or older at the time of informed consent.
• Able to move and stand without assistance
• Subjects must be proficient in spoken and written English for consenting as well as for study participation
• Subjects with medical conditions must be stable for these conditions. Stable control on medication is acceptable.
• Subject must have normal visual acuity (or corrected to normal) and normal color vision as indicated by self-report.
• Subject must have adequate hearing acuity as indicated by self-report.

You may not qualify if:

• Existing diagnosis of a neurodegenerative disorder (e.g., Alzheimer's Disease, Lewy Body Dementia, Frontal-Temporal Dementia).
• Prior diagnosis that might impact cognition and movement abilities including: cardiovascular or respiratory illness or injury, substance abuse, schizophrenia, bipolar disorder, or other neurological diseases (e.g., epilepsy, Parkinson's disease, seizure disorder).
• Affirmative answer to any Physical Activity Readiness Questionnaire for 70+ year-old adults (PAR-Q-70+) questionnaire.

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel Universitsy

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Motor Activity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

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: Assistant Professor

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: March 28, 2024
• Study Start: August 15, 2022
• Primary Completion: September 30, 2023
• Study Completion: January 31, 2024
• Last Updated: March 28, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)