Health in Motion- Interactive Exercises for Safer Mobility

Accidental Falls Clinical Trial

— HiM-O  

Official title:

Health in Motion- Interactive Exercises for Safer Mobility

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02475902
• Other study ID #: TC053013
• Status: Not yet recruiting
• Phase: N/A
• First received: June 15, 2015
• Last updated: June 26, 2015
• Start date: July 2015
• Est. completion date: April 2016

Study information

• Verified date: June 2015
• Source: Blue Marble Rehab Inc
• Contact: Sheryl Flynn, PhD
• Phone: 626-296-6400
• Email: sheryl[@]bluemarblegameco.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Accidental Falls

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Blue Marble Rehab Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	System Usability Scale (Questionnaire)		2 months	No
Primary	Change in Timed up and go test score		baseline, 1 month, 2 months	No
Secondary	Fear of Falling Avoidance Behavior Questionnaire		baseline, 1 month, 2 months	No
Secondary	Functional Reach Test		baseline, 1 month, 2 months	No
Secondary	Berg Balance Scale		baseline, 1 month, 2 months	No
Secondary	Health Related Quality of Life: SF-36		baseline, 1 month, 2 months	No