Accidental FallNCT03176511
Fall Prevention in Older Adults Study
A study testing A Matter of Balance plus Dual-Task Balance Challenge Group and A Matter of Balance Group in people with Accidental Fall and Postural Balance, run by University of Arizona at 1 site in United States.
Trial summary
Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Postural Balance
- What is being tested?
- A Matter of Balance plus Dual-Task Balance Challenge Group and A Matter of Balance Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2017to 30 Mar 2018
- 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
- Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score > 4), who live in the greater Tucson, AZ area.
Who cannot join
- Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).
Trial locations and contacts
1 site in 1 country.
United States1 site
El Rio Community Health Center
Tucson, Arizona, 85745
About this study
Official title: Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults
Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.
Read the detailed description
Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention ("dual-tasking") are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.
- Conditions
- Accidental Fall, Postural Balance
- Being tested
- A Matter of Balance plus Dual-Task Balance Challenge Group, A Matter of Balance Group
- Keywords
- older adults, dual task, A Matter of Balance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A Matter of Balance plus Dual-Task Balance Challenge GroupBehavioural
Also called MOB+DTBC Group
Participants will receive the standard MOB classes, along with a 15-min DTBC each class, i.e., right and left foot ankle-reaching to three differently colored markers. Three colored dots are placed on the ground in an arc, using different colored stick-on dots. A chair can be placed in front of the color pattern, as needed for safety.
A Matter of Balance GroupBehavioural
Also called MOB Group
Participants will receive the standard MOB class, taught by a certified MOB, using course materials developed by MaineHealth's Partnering for Healthy Aging (http://www.mainehealth.org/pfha).
| Study group | Role | What they receive |
|---|---|---|
| MOB+DTBC Group | Experimental | A Matter of Balance plus Dual-Task Balance Challenge Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of DTBC each class. Each class is 2 hours 15 minutes. Receives: Behavioral: A Matter of Balance plus Dual-Task Balance Challenge Group |
| MOB Group | Active comparator | A Matter of Balance Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of social time each class. Each class is 2 hours 15 minutes. Receives: Behavioral: A Matter of Balance Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance will be assessed using LEGSys™ (Locomotion Evaluation and Gait System, BioSensics LLC) wearable technology. This system uses five sensors attached to right and left anterior shins, right and left anterior thighs, and to the posterior lower back. Balance measures will include changes in sway of ankle, hip, and center of mass (COM) in both mediolateral (ML) and anterior/posterior (AP) directions while standing, with feet parallel and in semi-tandem positions, during eyes-open (EO) and eyes-closed (EC) conditions (30 seconds/test).
Measured: Data will be collected at baseline and post-intervention at 4 weeks.
Secondary outcomes (3)
Gait
Gait will be assessed over a distance of 20 meters using the LEGSys™ wearable technology. The system estimates spatiotemporal gait parameters including velocity, stride length, stride time, double support, single support, and stride-to-stride variability, and gait initiation. COM range of motion during walking will be calculated based on the data from the sensor attached to the lower back. Gait will be assessed under usual and maximal walking speeds.
Measured: Data will be collected at baseline and post-intervention at 4 weeks.
Fear of Falling
Fear of Falling is defined as concerns about falling. The Falls Efficacy Scale International (FES-I) is a self-report measure that assesses concerns about falling for 16 commonly performed activities at home and in community settings (e.g. get in/out of chair, walk in crowded places).
Measured: Data will be collected at baseline and post-intervention at 4 weeks.
3-month incident Fall Rates
Participants will be provided with 3 monthly fall calendars and asked to mark it daily (X=no fall, F=Fall) and record details of any fall injury/hospitalization on the back of the monthly sheet.
Measured: Data will be collected post-intervention at months 1, 2 and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start25 Jul 2017
- Primary completion11 Oct 2017
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accidental 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed pilot study will employ a single-blind, two-group randomized clinical trial. We will randomly assign 24 community-dwelling older adults (≥ 60 years) from an underserved population who are at high fall risk to either: A.) 4-week MOB+DTBC intervention, or B.) 4-week MOB only intervention (n=12/group).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth E Taylor-Piliae, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176511
- Sponsor's protocol ID
- RG2017-13
- Status last verified
- May 2017
- First submitted
- 1 Jun 2017
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults
- ClinicalTrials.gov ID
- NCT03176511
- Acronym / sponsor ID
- RG2017-13
- Conditions
- Accidental Fall, Postural Balance
- Keywords
- older adults, dual task, A Matter of Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 25 Jul 2017 (actual)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 5 Jun 2017 (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.
Poor balance is one of the major risk factors for falling in older adults. A Matter of Balance (MOB) is one of the most commonly used fall prevention programs nationally. Despite its name, MOB focuses on managing concerns about falling, and does not include a balance component. We are testing to see if adding a dual-task balance component (balance and mental thinking) to MOB can improve balance and walking better, than MOB only.
Detailed description
Fall prevention interventions among community-dwelling older adults are essential. A Matter of Balance (MOB) is one of the most commonly used community-based fall prevention interventions nationally, and is considered the 'fall prevention standard of care'. MOB programs are targeted to reduce the fear of falling and promote physical activity among all older community-dwelling adults. While evidence indicates that the MOB program leads to small, sustained decreases in older adults' perceived fear of falling, there is no evidence of objectively measured balance and gait. Despite its name, MOB focuses on cognitive restructuring to manage concerns about falling, and does not include a balance component. Among community-dwelling older adults, both intact balance and concomitant attention ("dual-tasking") are essential to prevent falls, and dual-task balance components are now requisite per evidence-based fall prevention intervention guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed pilot study will employ a single-blind, two-group randomized clinical trial. We will randomly assign 24 community-dwelling older adults (≥ 60 years) from an underserved population who are at high fall risk to either: A.) 4-week MOB+DTBC intervention, or B.) 4-week MOB only intervention (n=12/group).
| Arm | Type | Receives |
|---|---|---|
| MOB+DTBC Group | Experimental | Behavioral: A Matter of Balance plus Dual-Task Balance Challenge GroupA Matter of Balance plus Dual-Task Balance Challenge Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of DTBC each class. Each class is 2 hours 15 minutes. |
| MOB Group | Active comparator | Behavioral: A Matter of Balance GroupA Matter of Balance Group. Standardized MOB classes twice/week for 4 weeks, plus 15 minutes of social time each class. Each class is 2 hours 15 minutes. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Community-dwelling older adults from all sex/gender and racial/ethnic groups, aged ≥ 60 years, at high fall risk (FRQ=Fall Risk Questionnaire score > 4), who live in the greater Tucson, AZ area.
Key exclusion criteria (1 listed)
- Older adults currently attending MOB or other fall prevention classes (e.g. Fall Proof), having a severe mobility disorder (e.g., unable to walk 15 feet with an assistive device), severe visual or hearing impairment, non-English speaking, lack of decision-making capacity, unable to provide informed consent, serious psychiatric disorder (e.g., schizophrenia), moderately-severe depression (PHQ-9=Patient Health Questionnaire ≥ 15), cognitive impairment (MMSE=Mini-Mental Status Exam ≤ 23), or serious medical condition (e.g., cancer treatments).
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 |
|---|---|---|
| A Matter of Balance plus Dual-Task Balance Challenge GroupAlso: MOB+DTBC GroupParticipants will receive the standard MOB classes, along with a 15-min DTBC each class, i.e., right and left foot ankle-reaching to three differently colored markers. Three colored dots are placed on the ground in an arc, using different colored stick-on dots. A chair can be placed in front of the color pattern, as needed for safety. | Behavioural | MOB+DTBC Group |
| A Matter of Balance GroupAlso: MOB GroupParticipants will receive the standard MOB class, taught by a certified MOB, using course materials developed by MaineHealth's Partnering for Healthy Aging (http://www.mainehealth.org/pfha). | Behavioural | MOB Group |
Primary outcome
Balance
Time frame: Data will be collected at baseline and post-intervention at 4 weeks.
Balance will be assessed using LEGSys™ (Locomotion Evaluation and Gait System, BioSensics LLC) wearable technology. This system uses five sensors attached to right and left anterior shins, right and left anterior thighs, and to the posterior lower back. Balance measures will include changes in sway of ankle, hip, and center of mass (COM) in both mediolateral (ML) and anterior/posterior (AP) directions while standing, with feet parallel and in semi-tandem positions, during eyes-open (EO) and eyes-closed (EC) conditions (30 seconds/test).
3 secondary outcomes
Gait
Time frame: Data will be collected at baseline and post-intervention at 4 weeks.
Fear of Falling
Time frame: Data will be collected at baseline and post-intervention at 4 weeks.
3-month incident Fall Rates
Time frame: Data will be collected post-intervention at months 1, 2 and 3.
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 25 Oct 2018.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data (IPD) available to other researchers.
Related trials for Accidental Fall
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Effects of a Novel Perturbation Balance Training Program on Laboratory and Real-World Trip-Induced Losses of Balance and Falls Among Balance-Impaired Older Adults
Accidental Fall
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Whole-Body Point-of-Care Ultrasound in Older Adults Presenting to the Emergency Department After a Fall
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Preventing Loss of Independence Through Exercise in Community Living Centers
Dementia, Cognitive Dysfunction
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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.
Ruth E Taylor-Piliae, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A Matter of Balance plus Dual-Task Balance Challenge Group and A Matter of Balance Group in people with Accidental Fall and Postural Balance, run by University of Arizona 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 25 Oct 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?
Balance (time frame: Data will be collected at baseline and post-intervention at 4 weeks.). 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 25 Oct 2018.