Health in Motion- Interactive Exercises for Safer Mobility (HiM-O)

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.

Study Overview

• Status: Unknown
• Conditions: Accidental Falls
• Intervention / Treatment: Behavioral: Computer guided home exercise program; Behavioral: Paper guided home exercise program

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sheryl Flynn, PhD; Phone Number: 626-296-6400; Email: sheryl@bluemarblegameco.com
• Study Contact Backup: Name: Bonnie Kennedy, PhD; Phone Number: 626-296-6295; Email: bonnie@bluemarblegameco.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer guided home exercise program; A laptop computer & MS Kinect camera will be connected to a 40" TV to deliver guided fall prevention exercises. Research staff will train the participants in the use of the computerized program and be supervised performing the exercises during the instruction period. Then participants will be instructed to exercise 3 times per week for 4 weeks. Half of the participants will begin the study with the computerized version of the home exercise program while the other half begins with the paper booklet version of the home exercise program. After one month the arms will cross over.	Behavioral: Computer guided home exercise program; Participants will follow a computerized fall prevention home exercise program with MS Kinect camera tracking 3 times per week for one month.
Active Comparator: Paper guided home exercise program; A paper booklet with pictures and written instructions, and an exercise log for the home exercise program will be given to half of the participants. Participants will be carefully instructed in performing the exercises correctly and then asked to perform the exercises 3 times per week for one month. Participants who began the study with the paper exercise program will switch to the computerized version of the exercise program for the second month.	Behavioral: Paper guided home exercise program; Participants will follow a fall prevention home exercise program outlined in a paper booklet 3 times per week for one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Timed up and go test score	baseline, 1 month, 2 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
System Usability Scale (Questionnaire)	2 months

Collaborators and Investigators

• Sponsor: Blue Marble Rehab Inc
• Investigators: Principal Investigator: Sheryl Flynn, PhD, Blue Marble Rehabilitation, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): April 1, 2016

Study Registration Dates

• First Submitted: June 15, 2015
• First Submitted That Met QC Criteria: June 16, 2015
• First Posted (Estimate): June 19, 2015

Study Record Updates

• Last Update Posted (Estimate): June 30, 2015
• Last Update Submitted That Met QC Criteria: June 26, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: prevention and control
• Other Study ID Numbers: TC053013