Clinical trial NCT02475902: Health in Motion- Interactive Exercises for Safer Mobility
Official title: Health in Motion- Interactive Exercises for Safer Mobility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Keywords: prevention and control
Lead sponsor: Blue Marble Rehab Inc
Sponsor class: INDUSTRY
First posted: 2015-06-19
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Timed up and go test score
timeFrame: baseline, 1 month, 2 months
Secondary outcomes:
measure: Fear of Falling Avoidance Behavior Questionnaire
timeFrame: baseline, 1 month, 2 months
measure: Functional Reach Test
timeFrame: baseline, 1 month, 2 months
measure: Berg Balance Scale
timeFrame: baseline, 1 month, 2 months
measure: Health Related Quality of Life: SF-36
timeFrame: baseline, 1 month, 2 months
Other outcomes:
measure: System Usability Scale (Questionnaire)
timeFrame: 2 months
Locations:
Study officials:
affiliation: Blue Marble Rehabilitation, Inc.
name: Sheryl Flynn, PhD
role: PRINCIPAL_INVESTIGATOR
References: