Fall Prevention in Older Adults Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03176511|
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : October 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Accidental Fall Postural Balance||Behavioral: A Matter of Balance plus Dual-Task Balance Challenge Group Behavioral: A Matter of Balance Group||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Outcomes Assessor)|
|Masking Description:||As with any active intervention, participants will know their group assignment and double-blinding is not possible. Of note, our primary outcome measures are objective and require post-processing, thus study staff collecting the data will be "blinded" to participant results. Further, our bio-engineer post-processor will be blinded to study assignment.|
|Official Title:||Novel Dual-Task Balance Challenge to Prevent Falls in Older Adults|
|Actual Study Start Date :||July 25, 2017|
|Actual Primary Completion Date :||October 11, 2017|
|Actual Study Completion Date :||March 30, 2018|
Experimental: MOB+DTBC Group
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.
Behavioral: A Matter of Balance plus Dual-Task Balance Challenge 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.
Other Name: MOB+DTBC Group
Active Comparator: MOB Group
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.
Behavioral: A Matter of Balance 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).
Other Name: MOB Group
- 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).
- Gait [ Time Frame: Data will be collected at baseline and post-intervention at 4 weeks. ]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.
- Fear of Falling [ Time Frame: Data will be collected at baseline and post-intervention at 4 weeks. ]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).
- 3-month incident Fall Rates [ Time Frame: Data will be collected post-intervention at months 1, 2 and 3. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03176511
|United States, Arizona|
|El Rio Community Health Center|
|Tucson, Arizona, United States, 85745|
|Principal Investigator:||Ruth E Taylor-Piliae, PhD||University of Arizona|