Postural BalanceNCT02949986
Feasibility of a Tablet-based Fall Prevention Program for Older Adults
A study testing Tablet-based Fall Prevention in people with Postural Balance, run by East Tennessee State University at 1 site in United States.
Trial summary
There are many exercise approaches that have demonstrated effectiveness in reducing falls and fall risk in community-dwelling older adults. The Otago Exercise Program is one such program. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postural Balance
- What is being tested?
- Tablet-based Fall Prevention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2016to 31 Dec 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age at least 60 years, ability to ambulate household distance without an assistive device; and ability to stand independently for twenty minutes
Who cannot join
- cognitive impairment (based on Mini Mental Status Exam), unstable medical condition, progressive neurological condition, severe pain with weight bearing, and severe vision impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
There are many exercise approaches that have demonstrated effectiveness in reducing falls and fall risk in community-dwelling older adults. The Otago Exercise Program is one such program. The Otago Exercise Program has been tested in four randomized controlled trials and one controlled multi-center trial and was found to reduce falls in older men and women. The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The goal of the current study is to evaluate whether a self-administered, tablet-based version of the Otago fall prevention program is both feasible and effective for reducing fall risk and improving balance in community-dwelling older adults.
Read the detailed description
Twenty community-dwelling older adults who satisfy the study criteria will be recruited to participate in this study. This group of participants will be selected to represent the general community-dwelling older adults as much as possible. They will demonstrate a range of ability in terms of their balance and mobility in which some are non-fallers and some fallers. All adults who meet the inclusion/exclusion criteria and have access to the internet via wireless connection will be included.
Participants will be consented for the research study and will be assessed initially, after 1 month of exercise and at the end of 2 months of exercise. Assessment will include questionnaires about health history, including falls, physical activity, balance confidence and system usability. Participants will also complete strength, balance and mobility physical performance tests. Age, sex, presence of comorbidities, medication list, functional abilities, balance confidence, fear of fall behavior and fall history will be assessed by questionnaire. Usability of the tablet-based questionnaire will be assessed by questionnaire. Participants will be tested with standard clinical tests of balance and gait.
Participants will be closely supervised by a Doctor of Physical Therapy (DPT) student during training in how to use the exercise program. Participants will complete a full set of exercises with the tablet in the presence of the DPT student. The DPT student will determine whether participants are safe with the program before allowing them to perform the program on their own at home. If the research team determines that a participant is unable to exercise safely on his/her own he/she will be withdrawn from the study.
The tablet-based, video game exercise program is called Health in Motion and was developed by Blue Marble Game Company. Health in Motion was tested in a pilot study and found to reduce fall risk in 8 of 15 older participants without any adverse events. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months.
Performance scores from the clinical gait and balance measures obtained during the initial visit will be compared to the performance scores obtained after 1 month and 2 months of performing the exercise program. We hypothesize that balance and gait will improve following 2 months of performing the tablet-based fall prevention exercise program at home. The assessments performed by the DPT students and by the participant using the app will be compared. We hypothesize that the scores from self-assessment will closely correlate to the students' assessment. The system usability score will be examined to understand issues associated with using technology. We hypothesize that older adults will enjoy performing the exercises using the tablet format.
- Conditions
- Postural Balance
- Being tested
- Tablet-based Fall Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet-based Fall PreventionBehavioural
The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The program will be self-administered via tablet-based version of the Otago fall prevention program. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months.
| Study group | Role | What they receive |
|---|---|---|
| Tablet-based Fall Prevention | Experimental | The exercise program will be self-administered via a tablet-based version of the fall prevention program and the exercises performed in the home. Receives: Behavioral: Tablet-based Fall Prevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity-specific balance confidence (ABC)
ABC is a 16-item questionnaire regarding confidence to perform different activities (e.g., walking around the house, up and down stairs, and on icy surfaces) without losing balance. The scale ranges from 0% (no confidence at all) to 100% (completely confident). An overall average balance confidence score will be calculated for each subject.
Measured: 2 months
Secondary outcomes (7)
Timed up and go test (TUG)
The timed up and go test (TUG) is commonly used to assess functional mobility in older adults and is sensitive to fall risk (Shumway-Cook et al., 2000). The test involves standing up, walking as quickly and safely as possible for 3 m, turning around, walking back and then sitting down. Time to complete the TUG will be recorded.
Measured: 2 months
Functional Gait Assessment (FGA)
The 10 items of the FGA include walking while changing speed and turning the head, walking over obstacles, walking tandem, backward and with eyes closed and stair climbing. A maximum total score of 30 is possible with scores < 22 indicating high risk for falling (Wrisley et al., 2010).
Measured: 2 months
Preferred gait speed
Gait speed will be determined by instructing participants to walk at their normal pace over a 9-m pathway. The time to walk the middle 6 m will be measured using a stopwatch and gait speed calculated. Gait speed has excellent test-retest reliability (r = 0.90; Bohannon, 1997) and slower gait speed is associated with fall risk (Montero-Odasso et al., 2005).
Measured: 2 months
Single Leg Stance Test
The Single Leg Stance Test is a test of balance and requires participants to stand on one leg for up to 30 seconds. Up to three trials, using each leg will be performed. SLS is correlated with injurious falls (Vellas et al., 1997).
Measured: 2 months
Modified clinical test of sensory interaction on balance (mCTSIB)
The mCTSIB is organized into a series of 4 conditions of increasing difficulty and timed for a maximum of 30 seconds for each condition. The first two conditions involve a stable support surface with eyes open and eyes closed. The last two conditions involve a foam surface with eyes open and eyes closed. The mCTSIB score is the sum of the average time for each condition.
Measured: 2 months
Physical Activity Scale for the Elderly (PASE)
The PASE is comprised of self-reported occupational, household and leisure items over a one-week period and can be administered by telephone, mail or in-person.
Measured: 2 months
Fear of Falling Avoidance Behavior Questionnaire
The Fear of Falling Avoidance Behavior Questionnaire is a 14 item questionnaire that measures avoidance of behaviors due to fear of falling (Landers, Durand, Powell, Dibble, Young, 2011).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2016 (estimated)
- Study start1 Aug 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Courtney D. Hall, East Tennessee State University
- Investigators
- Courtney Hall, PhD, Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02949986
- Sponsor's protocol ID
- ETSUIRB0716.5f
- Status last verified
- Mar 2018
- First submitted
- 27 Oct 2016
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Tablet-based Fall Prevention Program for Older Adults
- ClinicalTrials.gov ID
- NCT02949986
- Acronym / sponsor ID
- ETSUIRB0716.5f
- Conditions
- Postural Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Oct 2016 (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.
There are many exercise approaches that have demonstrated effectiveness in reducing falls and fall risk in community-dwelling older adults. The Otago Exercise Program is one such program. The Otago Exercise Program has been tested in four randomized controlled trials and one controlled multi-center trial and was found to reduce falls in older men and women. The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The goal of the current study is to evaluate whether a self-administered, tablet-based version of the Otago fall prevention program is both feasible and effective for reducing fall risk and improving balance in community-dwelling older adults.
Detailed description
Twenty community-dwelling older adults who satisfy the study criteria will be recruited to participate in this study. This group of participants will be selected to represent the general community-dwelling older adults as much as possible. They will demonstrate a range of ability in terms of their balance and mobility in which some are non-fallers and some fallers. All adults who meet the inclusion/exclusion criteria and have access to the internet via wireless connection will be included.
Participants will be consented for the research study and will be assessed initially, after 1 month of exercise and at the end of 2 months of exercise. Assessment will include questionnaires about health history, including falls, physical activity, balance confidence and system usability. Participants will also complete strength, balance and mobility physical performance tests. Age, sex, presence of comorbidities, medication list, functional abilities, balance confidence, fear of fall behavior and fall history will be assessed by questionnaire. Usability of the tablet-based questionnaire will be assessed by questionnaire. Participants will be tested with standard clinical tests of balance and gait.
Participants will be closely supervised by a Doctor of Physical Therapy (DPT) student during training in how to use the exercise program. Participants will complete a full set of exercises with the tablet in the presence of the DPT student. The DPT student will determine whether participants are safe with the program before allowing them to perform the program on their own at home. If the research team determines that a participant is unable to exercise safely on his/her own he/she will be withdrawn from the study.
The tablet-based, video game exercise program is called Health in Motion and was developed by Blue Marble Game Company. Health in Motion was tested in a pilot study and found to reduce fall risk in 8 of 15 older participants without any adverse events. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months.
Performance scores from the clinical gait and balance measures obtained during the initial visit will be compared to the performance scores obtained after 1 month and 2 months of performing the exercise program. We hypothesize that balance and gait will improve following 2 months of performing the tablet-based fall prevention exercise program at home. The assessments performed by the DPT students and by the participant using the app will be compared. We hypothesize that the scores from self-assessment will closely correlate to the students' assessment. The system usability score will be examined to understand issues associated with using technology. We hypothesize that older adults will enjoy performing the exercises using the tablet format.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tablet-based Fall Prevention | Experimental | Behavioral: Tablet-based Fall PreventionThe exercise program will be self-administered via a tablet-based version of the fall prevention program and the exercises performed in the home. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age at least 60 years, ability to ambulate household distance without an assistive device; and ability to stand independently for twenty minutes
Key exclusion criteria (1 listed)
- cognitive impairment (based on Mini Mental Status Exam), unstable medical condition, progressive neurological condition, severe pain with weight bearing, and severe vision impairment
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 |
|---|---|---|
| Tablet-based Fall PreventionThe focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The program will be self-administered via tablet-based version of the Otago fall prevention program. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months. | Behavioural | Tablet-based Fall Prevention |
Primary outcome
Activity-specific balance confidence (ABC)
Time frame: 2 months
ABC is a 16-item questionnaire regarding confidence to perform different activities (e.g., walking around the house, up and down stairs, and on icy surfaces) without losing balance. The scale ranges from 0% (no confidence at all) to 100% (completely confident). An overall average balance confidence score will be calculated for each subject.
7 secondary outcomes
Timed up and go test (TUG)
Time frame: 2 months
Functional Gait Assessment (FGA)
Time frame: 2 months
Preferred gait speed
Time frame: 2 months
Single Leg Stance Test
Time frame: 2 months
Modified clinical test of sensory interaction on balance (mCTSIB)
Time frame: 2 months
Physical Activity Scale for the Elderly (PASE)
Time frame: 2 months
Fear of Falling Avoidance Behavior Questionnaire
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for Postural Balance
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Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
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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.
Courtney Hall, PhD principal investigator
East Tennessee State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tablet-based Fall Prevention in people with Postural Balance, run by East Tennessee State University at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity-specific balance confidence (ABC) (time frame: 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 29 Mar 2018.