Clinical trial NCT02949986: Feasibility of a Tablet-based Fall Prevention Program for Older Adults
Official title: Feasibility of a Tablet-based Fall Prevention Program for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2016-10-31
Enrollment: 11
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* age at least 60 years, ability to ambulate household distance without an assistive device; and ability to stand independently for twenty minutes

Exclusion Criteria:

* cognitive impairment (based on Mini Mental Status Exam), unstable medical condition, progressive neurological condition, severe pain with weight bearing, and severe vision impairment

Primary outcomes:
measure: Activity-specific balance confidence (ABC)
timeFrame: 2 months
Secondary outcomes:
measure: Timed up and go test (TUG)
timeFrame: 2 months
measure: Functional Gait Assessment (FGA)
timeFrame: 2 months
measure: Preferred gait speed
timeFrame: 2 months
measure: Single Leg Stance Test
timeFrame: 2 months
measure: Modified clinical test of sensory interaction on balance (mCTSIB)
timeFrame: 2 months
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: 2 months
measure: Fear of Falling Avoidance Behavior Questionnaire
timeFrame: 2 months
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: East Tennessee State University
state: Tennessee
Study officials:
affiliation: East Tennessee State University
name: Courtney Hall, PhD
role: PRINCIPAL_INVESTIGATOR
References: