Health in Motion- Interactive Exercises for Safer Mobility
HiM-O
1 other identifier
interventional
36
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2015
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2015
CompletedFirst Posted
Study publicly available on registry
June 19, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedJune 30, 2015
June 1, 2015
9 months
June 15, 2015
June 26, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Timed up and go test score
baseline, 1 month, 2 months
Secondary Outcomes (4)
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 Outcomes (1)
System Usability Scale (Questionnaire)
2 months
Study Arms (2)
Computer guided home exercise program
EXPERIMENTALA 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.
Paper guided home exercise program
ACTIVE COMPARATORA 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.
Interventions
Participants will follow a computerized fall prevention home exercise program with MS Kinect camera tracking 3 times per week for one month.
Participants will follow a fall prevention home exercise program outlined in a paper booklet 3 times per week for one month.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- PRINCIPAL INVESTIGATOR
Sheryl Flynn, PhD
Blue Marble Rehabilitation, Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2015
First Posted
June 19, 2015
Study Start
July 1, 2015
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
June 30, 2015
Record last verified: 2015-06