ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02475902
Recruitment Status : Unknown
Verified June 2015 by Blue Marble Rehab Inc.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2015
Last Update Posted : June 30, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Accidental Falls Behavioral: Computer guided home exercise program Behavioral: Paper guided home exercise program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Health in Motion- Interactive Exercises for Safer Mobility
Study Start Date : July 2015
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in Timed up and go test score [ Time Frame: baseline, 1 month, 2 months ]

Secondary Outcome Measures :
  1. Fear of Falling Avoidance Behavior Questionnaire [ Time Frame: baseline, 1 month, 2 months ]
  2. Functional Reach Test [ Time Frame: baseline, 1 month, 2 months ]
  3. Berg Balance Scale [ Time Frame: baseline, 1 month, 2 months ]
  4. Health Related Quality of Life: SF-36 [ Time Frame: baseline, 1 month, 2 months ]

Other Outcome Measures:
  1. System Usability Scale (Questionnaire) [ Time Frame: 2 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02475902


Contacts
Contact: Sheryl Flynn, PhD 626-296-6400 sheryl@bluemarblegameco.com
Contact: Bonnie Kennedy, PhD 626-296-6295 bonnie@bluemarblegameco.com

Sponsors and Collaborators
Blue Marble Rehab Inc
Investigators
Principal Investigator: Sheryl Flynn, PhD Blue Marble Rehabilitation, Inc.

Responsible Party: Blue Marble Rehab Inc
ClinicalTrials.gov Identifier: NCT02475902     History of Changes
Other Study ID Numbers: TC053013
First Posted: June 19, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by Blue Marble Rehab Inc:
prevention and control