Accidental FallsHiM-ONCT02475902
Health in Motion- Interactive Exercises for Safer Mobility
A study testing Computer guided home exercise program and Paper guided home exercise program in people with Accidental Falls, run by Blue Marble Rehab Inc.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls
- What is being tested?
- Computer guided home exercise program and Paper guided home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Accidental Falls
- Being tested
- Computer guided home exercise program, Paper guided home exercise program
- Keywords
- prevention and control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer guided home exercise programBehavioural
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 programBehavioural
Participants will follow a fall prevention home exercise program outlined in a paper booklet 3 times per week for one month.
| Study group | Role | What they receive |
|---|---|---|
| Computer guided home exercise program | Experimental | 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. Receives: Behavioral: Computer guided home exercise program |
| Paper guided home exercise program | Active comparator | 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. Receives: Behavioral: Paper guided home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Timed up and go test score
Measured: baseline, 1 month, 2 months
Secondary outcomes (4)
Fear of Falling Avoidance Behavior Questionnaire
Measured: baseline, 1 month, 2 months
Functional Reach Test
Measured: baseline, 1 month, 2 months
Berg Balance Scale
Measured: baseline, 1 month, 2 months
Health Related Quality of Life: SF-36
Measured: baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blue Marble Rehab Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sheryl Flynn, PhD, Principal investigator, Blue Marble Rehabilitation, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475902
- Sponsor's protocol ID
- TC053013
- Acronym
- HiM-O
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health in Motion- Interactive Exercises for Safer Mobility
- ClinicalTrials.gov ID
- NCT02475902
- Acronym / sponsor ID
- HiM-O / TC053013
- Conditions
- Accidental Falls
- Keywords
- prevention and control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Blue Marble Rehab IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer guided home exercise program | Experimental | Behavioral: Computer guided home exercise programA 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 comparator | Behavioral: Paper guided home exercise programA 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer guided home exercise programParticipants will follow a computerized fall prevention home exercise program with MS Kinect camera tracking 3 times per week for one month. | Behavioural | Computer guided home exercise program |
| Paper guided home exercise programParticipants will follow a fall prevention home exercise program outlined in a paper booklet 3 times per week for one month. | Behavioural | Paper guided home exercise program |
Primary outcome
Change in Timed up and go test score
Time frame: baseline, 1 month, 2 months
4 secondary outcomes
Fear of Falling Avoidance Behavior Questionnaire
Time frame: baseline, 1 month, 2 months
Functional Reach Test
Time frame: baseline, 1 month, 2 months
Berg Balance Scale
Time frame: baseline, 1 month, 2 months
Health Related Quality of Life: SF-36
Time frame: baseline, 1 month, 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheryl Flynn, PhD principal investigator
Blue Marble Rehabilitation, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing Computer guided home exercise program and Paper guided home exercise program in people with Accidental Falls, run by Blue Marble Rehab Inc.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheryl Flynn, PhD (626-296-6400, sheryl@bluemarblegameco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Timed up and go test score (time frame: baseline, 1 month, 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.