Health in Motion- Interactive Exercises for Safer Mobility

Not Applicable

• Conditions: Accidental Falls

• Registration Number: NCT02475902
• Lead Sponsor: Blue Marble Rehab Inc

Brief Summary

The participants will complete a series of balance assessments with a licensed physical (PT) or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or in their respective homes at the start of the study, at crossover and upon completion of the study. During this study a PT, OT, or RA trained in fall risk management will supervise the instruction and practice by participants of the home exercise programs during the initial 2-3 hour introduction to the study activities. Participants will be asked to exercise 3/week for one month then crossover to the alternative exercise program and exercise 3/week for a second month.

Detailed Description

The participants will complete a series of balance assessments with a licensed physical (PT) or occupational therapist (OT) or qualified research assistant (RA) at Blue Marble Game Co or in their respective homes at the start of the study, at cross over and upon completion of the study. During this study a PT, OT, or RA trained in fall risk management will supervise the instruction and practice by participants of the home exercise programs during the initial 2-3 hour introduction to the study activities. Participants will be asked to exercise 3/week for one month then crossover to the alternative exercise program and exercise 3/week for a second month. The PT, OT, or RA will determine that the participant is competent to perform the home exercise programs safely, with no more than a normal risk of falls or withdraw the participant from the study. The participant's score on the standard version of the Falls Risk Questionnaire, Single Leg Stance Test, and Chair Rise Test will be recorded and stored on a password protected computer in a locked office. Once the data has been stored electronically, paper data collection sheets will be placed in a confidential bin for shredding. Exercise Data will be captured using a) the Health In Motion software via the Kinect Sensor and stored on the Blue Marble secure server and b) via a daily exercise log provided to the participant in paper form.

Study Timeline

• Status Verified: 2015-06
• Study First Submitted: 2015-06-15
• Study First Submitted QC: 2015-06-16
• Study First Posted: 2015-06-19
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-06-30
• Study Start: 2015-07
• Primary Completion: 2016-04
• Study Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Health status: Individuals medically stable and have no medical condition that would affect their participation in group discussion or that would affect their ability to perform the balance assessments or balance exercises. The participants for Study 1 and 2 are required to walk 500 feet independently without an assistive device (e.g. walker, cane or person).
• Gender: 50%/50% male and female
• Ability to speak/read English fluently (focus group will be conducted in English & art work will have English text)
• For Study 1 and 2, the participant must have had less than 2 falls in the past 12 months.

Exclusion Criteria

• History of seizure activity when watching TV or when playing video games.
• Unable to learn to use the technology safely without direct supervision.
• Insufficient clear, safe exercise space in the home with internet access.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Change in Timed up and go test score	baseline, 1 month, 2 months

Secondary Outcome Measures

Name	Time	Method
Fear of Falling Avoidance Behavior Questionnaire	baseline, 1 month, 2 months
Berg Balance Scale	baseline, 1 month, 2 months
Functional Reach Test	baseline, 1 month, 2 months
Health Related Quality of Life: SF-36	baseline, 1 month, 2 months