Skip to content

Health in Motion Pragmatic Clinical Trial - WRAPAROUND

Health in Motion- A Digital Fall Prevention Program Designed to be Delivered as a Wraparound Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06619496
Enrollment
63
Registered
2024-10-01
Start date
2022-10-24
Completion date
2024-07-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

fall, fall prevention, fall injury, fear of falling, fall efficacy

Brief summary

Falls among older adults are a serious public health concern, and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will compare a digital fall prevention program used in a group setting in the community with traditional community-based fall prevention programs.

Detailed description

This study will involve 2 groups. Group 1 will participate in traditional human-led community based fall prevention programs and Group 2 will participate in avatar-led community-based fall prevention program. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the European Quality of Life 5-Dimensional Questionnaire, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

Interventions

BEHAVIORALHuman-led fall prevention program

Human-led evidence-based fall prevention programs include Matter of Balance, Tai Chi Moving for Better Balance, Walk with Ease, or Arthritis Exercise

BEHAVIORALAvatar-led fall prevention program

The avatar-led fall prevention program consists of the Otago Exercise Program

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Partners In Care Foundation
CollaboratorUNKNOWN
Blue Marble Rehab Inc
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

comparative prospective observational cohort study

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* age of 55 and older * Score \>30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate

Exclusion criteria

* any person who has been told by their physician that they should not exercise

Design outcomes

Primary

MeasureTime frameDescription
Rate of fallschange from baseline to end of intervention (about 3 months)number of falls during the intervention compared with the self-reported falls at baseline

Secondary

MeasureTime frameDescription
4 Stage Balance Testchange from baseline to end of intervention (about 3 months)This test measures the ability to stand for 10 seconds in 4 progressively more challenging positions from standing with feet side by side to standing on one leg. The score is equal to the total time taken to achieve the highest level. The maximum score is 40. If a participant is not able to stand with their feet in tandem, they are considered at higher risk of falling.
One Leg Stand Testchange from baseline to end of intervention (about 3 months)This test measures the ability to stand for on one leg for up to 30 seconds. If a participant is not able to stand for 5 seconds, they are considered at higher risk of falling.
30 Second Sit to Stand Testchange from baseline to end of intervention (about 3 months)This test measures the number of times a participant can stand up from a seated position in 30 seconds.
Fall Risk Questionnairechange from baseline to end of intervention (about 3 months)This is a multi-factorial questionnaire that can be used to predict fall risk. Questions relate to history of falls, gait/balance, muscle weakness, incontinence, sensation/proprioception, depression, vision and medications. The highest (worst) score = 14. A score of 0-3 denotes low fall risk and scores from 4-14 denote higher fall risk.
Activities Specific Balance Confidence Scale (5 level)change from baseline to end of intervention (about 3 months)This questionnaire measures the participant's confidence in performing activities of daily living in which each item is rated from 0% (no confidence) to 100% (complete confidence). It correlates with other measures of self-efficacy and balance measures.
Timed Up and Go Testchange from baseline to end of intervention (about 3 months)Time taken to stand up from a seated position, walk 10 feet, turn around, return to the chair, sit down
European Quality of Life 5-Dimensional Questionnaire (EQ-5D-5L)change from baseline to end of intervention (about 3 months)This is a standardized measure of health status for clinical and economic appraisal. The test is a self report health state that domains including mobility, self-care, anxiety/depression, pain/discomfort) using a 5 point scale and a visual analog scale (VAS).
Trail Making Testchange from baseline to end of intervention (about 3 months)This is a standardized test of cognitive function. The test consists of two Trails, Trail A and Trail B. Trail A requires the participant to tap on 25 numbers on the screen in order from smallest to largest (1, 2, 3, etc). Trail B requires participants to tap on alternative numbers and letters in consecutive order from smallest/first to largest/last (1, A, 2, B, 3, C etc).
modified Fear of Falling Avoidance Behavior Questionnaire (mFFABQ)change from baseline to end of intervention (about 3 months)This is a standardized self-report assessment that measures behaviors that may be avoided due to a fear of falling. The item scores are summed to form a total score ranging from 0 to 56. Higher scores indicate a higher level of fear of falling avoidance behavior
Upstream Social Isolation Risk Scale (USIR-S)change from baseline to end of intervention (about 3 months)A standardized assessment of social isolation. Lower scores indicate lower risk of social isolation.
Veteran Rand-12 (VR-12)change from baseline to end of intervention (about 3 months)This questionnaire measures quality of life over the past 4 weeks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026