FallNCT05140044
Use of a Smartphone to Assess Balance and Provide Intervention to Older Adults at Home
A study testing Balance Exercises - Smartphone Delivery and Balance Exercises - Traditional Paper Delivery in people with Fall, run by Binghamton University at 1 site in United States.
Trial summary
Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming… Read more about this study
- Who is it for?
- Ages 65 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Fall
- What is being tested?
- Balance Exercises - Smartphone Delivery and Balance Exercises - Traditional Paper Delivery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2022to 24 Apr 2023
- 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 65 to 90 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Able to ambulate at least 10 meters without an assistive device.
- Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MOCA) - Blind.
Who cannot join
- Lower limb amputation
- Lower limb arthroplasty
- Visual impairment uncorrectable with lenses
- Uncontrolled hypertension or diabetes
- Neurological or musculoskeletal impairment
- Persistent symptoms of dizziness or lightheadedness
Trial locations and contacts
1 site in 1 country.
United States1 site
Binghamton University - Motion Analysis Laboratory
Binghamton, New York, 13902
About this study
Official title: Longitudinal Home-based Evaluation of Balance and Exercise in Older Adults With and Without a History of Falls
Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming, and dependent on qualified technicians to properly collect and evaluate the data. Furthermore, these one-time gait and balance assessments cannot monitor changes in ambulatory strategies longitudinally and do not reflect performance in real-life environments, where falls commonly occur. While recent developments in smartphone-based evaluations have demonstrated great utility and accuracy in assessing gait performance, it is vital to evaluate participant compliance, ease-of-use, and feasibility of this technology using a smartphone in the home environment.
It is also paramount that interventions which improve balance be accessible to older adults. While four-week balance training routines have been shown to improve balance performance among older adults, it is unknown whether such interventions can be conducted remotely in a safe and compliant manner. Furthermore, the retention of balance function following intervention is unclear. Subsequently, the goals of this study are to evaluate technology that can both remotely monitor balance and prescribe intervention to older adults. With the current burdens on the health care system and the burgeoning population of older adults, it is essential that tools be provided to older adults that are easy to follow, attractive, and improve balance performance.
Therefore, the objective of this project is to investigate the utility of a valid, easily accessible, smartphone application to assess balance and provide personalized exercise for older adults as a stand-alone, field-based medical device. The aims of this proposal are to (1) utilize a smartphone application to longitudinally evaluate gait and standing balance over an 8-week period in the home environment among 30; and (2) determine the feasibility and efficacy of a smartphone application to promote exercise and evaluate gait changes for up to 2 months in this older adult population following a 4-week balance intervention. The long-term goal of this project is to provide a holistic home-based gait monitoring and intervention tool for integration in routine clinical care.
- Conditions
- Fall
- Being tested
- Balance Exercises - Smartphone Delivery, Balance Exercises - Traditional Paper Delivery
- Keywords
- Older Adults, Balance, Smartphone, Home-based Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance Exercises - Smartphone DeliveryDevice
1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.
Balance Exercises - Traditional Paper DeliveryOther
1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks.
| Study group | Role | What they receive |
|---|---|---|
| Home - Paper Intervention | Active comparator | Older adults who are given a 4-week paper-based balance intervention program. Performed 3days/week for 30min/day over the course of a 4-week period using printed materials with text instruction and images. Receives: Other: Balance Exercises - Traditional Paper Delivery |
| Home - Smartphone Intervention | Experimental | Older adults who are given a 4-week home-based balance exercise program. Performed 3days/week for 30min/day over the course of a 4-week period using participants' smartphones. Receives: Device: Balance Exercises - Smartphone Delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Task Gait Velocity
self-selected walking speed under dual task gait/cognitive conditions
Measured: Baseline
Dual Task Gait Velocity
self-selected walking speed under dual task gait/cognitive conditions
Measured: One-month following baseline
Dual Task Gait Velocity
self-selected walking speed under dual task gait/cognitive conditions
Measured: Two-months following baseline
Secondary outcomes (6)
Dual Task Verbal Reaction Time
Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions
Measured: Baseline
Dual Task Verbal Reaction Time
Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions
Measured: One-month following baseline
Dual Task Verbal Reaction Time
Time taken to verbally respond to auditory stimulus under dual task gait/cognitive conditions
Measured: Two-months following baseline
Dual Task Standing Balance
Path of Center of Pressure (COP) during standing and performing secondary cognitive task
Measured: Baseline
Dual Task Standing Balance
Path of COP during standing and performing secondary cognitive task
Measured: One-month following baseline
Dual Task Standing Balance
Path of COP during standing and performing secondary cognitive task
Measured: Two-months following baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start13 Oct 2022
- Primary completion24 Apr 2023
- Study completion24 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vipul Lugade, Binghamton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05140044
- Sponsor's protocol ID
- Smartphone Balance & Exercise
- Status last verified
- Jun 2023
- First submitted
- 9 Nov 2021
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) including demographic, gait, posture, and cognitive results as well as exercise conditions will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Home-based Evaluation of Balance and Exercise in Older Adults With and Without a History of Falls
- ClinicalTrials.gov ID
- NCT05140044
- Acronym / sponsor ID
- Smartphone Balance & Exercise
- Conditions
- Fall
- Keywords
- Older Adults, Balance, Smartphone, Home-based Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 24 Apr 2023 (actual)
- Study completion
- 24 Apr 2023 (actual)
- First posted
- 1 Dec 2021 (actual)
- 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.
Approximately one-third of older adults report one or more falls each year, with devastating physical, psychological, social, and financial consequences. Conventional gait analysis performed in a controlled laboratory environment can identify balance deficits, but unfortunately, such tools are bulky, time-consuming, and dependent on qualified technicians to properly collect and evaluate the data. Furthermore, these one-time gait and balance assessments cannot monitor changes in ambulatory strategies longitudinally and do not reflect performance in real-life environments, where falls commonly occur. While recent developments in smartphone-based evaluations have demonstrated great utility and accuracy in assessing gait performance, it is vital to evaluate participant compliance, ease-of-use, and feasibility of this technology using a smartphone in the home environment.
It is also paramount that interventions which improve balance be accessible to older adults. While four-week balance training routines have been shown to improve balance performance among older adults, it is unknown whether such interventions can be conducted remotely in a safe and compliant manner. Furthermore, the retention of balance function following intervention is unclear. Subsequently, the goals of this study are to evaluate technology that can both remotely monitor balance and prescribe intervention to older adults. With the current burdens on the health care system and the burgeoning population of older adults, it is essential that tools be provided to older adults that are easy to follow, attractive, and improve balance performance.
Therefore, the objective of this project is to investigate the utility of a valid, easily accessible, smartphone application to assess balance and provide personalized exercise for older adults as a stand-alone, field-based medical device. The aims of this proposal are to (1) utilize a smartphone application to longitudinally evaluate gait and standing balance over an 8-week period in the home environment among 30; and (2) determine the feasibility and efficacy of a smartphone application to promote exercise and evaluate gait changes for up to 2 months in this older adult population following a 4-week balance intervention. The long-term goal of this project is to provide a holistic home-based gait monitoring and intervention tool for integration in routine clinical care.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home - Paper Intervention | Active comparator | Other: Balance Exercises - Traditional Paper DeliveryOlder adults who are given a 4-week paper-based balance intervention program. Performed 3days/week for 30min/day over the course of a 4-week period using printed materials with text instruction and images. |
| Home - Smartphone Intervention | Experimental | Device: Balance Exercises - Smartphone DeliveryOlder adults who are given a 4-week home-based balance exercise program. Performed 3days/week for 30min/day over the course of a 4-week period using participants' smartphones. |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Able to ambulate at least 10 meters without an assistive device.
- Cognitively intact based on scoring 18/22 or greater on the Montreal Cognitive Assessment (MOCA) - Blind.
Key exclusion criteria (6 listed)
- Lower limb amputation
- Lower limb arthroplasty
- Visual impairment uncorrectable with lenses
- Uncontrolled hypertension or diabetes
- Neurological or musculoskeletal 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 |
|---|---|---|
| Balance Exercises - Smartphone Delivery1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks. | Device | Home - Smartphone Intervention |
| Balance Exercises - Traditional Paper Delivery1st week: standing balance tasks; 2nd week: standing with arm manipulation tasks; 3rd week: gait balance tasks; 4th week: gait with arm manipulation tasks. | Other | Home - Paper Intervention |
Primary outcome
Dual Task Gait Velocity
Time frame: Baseline
self-selected walking speed under dual task gait/cognitive conditions
Dual Task Gait Velocity
Time frame: One-month following baseline
self-selected walking speed under dual task gait/cognitive conditions
Dual Task Gait Velocity
Time frame: Two-months following baseline
self-selected walking speed under dual task gait/cognitive conditions
6 secondary outcomes
Dual Task Verbal Reaction Time
Time frame: Baseline
Dual Task Verbal Reaction Time
Time frame: One-month following baseline
Dual Task Verbal Reaction Time
Time frame: Two-months following baseline
Dual Task Standing Balance
Time frame: Baseline
Dual Task Standing Balance
Time frame: One-month following baseline
Dual Task Standing Balance
Time frame: Two-months following baseline
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 18 Jun 2023.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) including demographic, gait, posture, and cognitive results as well as exercise conditions will be shared.
Related trials for Fall
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Pilates vs. Core Stabilization for Balance and Mobility in Elderly Type 2 Diabetics
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balance Exercises - Smartphone Delivery and Balance Exercises - Traditional Paper Delivery in people with Fall, run by Binghamton 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 2 inclusion and 6 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 18 Jun 2023. 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?
Dual Task Gait Velocity (time frame: Baseline). The study lists 3 primary outcomes in all. 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 18 Jun 2023.