An interventional study of Smartphone-Based Intervention and Group-Based Intervention in Frail Elderly and Fall, sponsored by Binghamton University. Recruiting at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Binghamton University · Not applicable, Interventional, and Treatment
The long-term goal of this project is to effectively bridge the research-clinic-community gap and to foster partnerships that support the implementation, utilization, and advocacy of evidence-based fall prevention programs in the older adult community. The Otago Exercise Program (OEP) is an evidence-based fall prevention program that has been shown to reduce falls and fall-related injuries among older adults. Traditionally, OEP is delivered in the home by a physical therapist and focuses on muscle strengthening and balance training. Despite its proven effectiveness, adherence and compliance rates have been low. The personnel and resource demands of program delivery, along with challenges in monitoring participant adherence, represent significant barriers to broader implementation. Alternative delivery systems using remote and community-based platforms may help address these limitations.
Specific Aim 1: To compare the effectiveness of two delivery modes of the Otago Exercise Program: a remotely delivered, home-based smartphone program and an in-person, community-based program.
Specific Aim 2: To examine the feasibility, acceptability, and usability of the Otago Exercise Program delivered through both smartphone-based and in-person formats.
Thirty eligible participants will provide written informed consent prior to enrollment. In accordance with the World Guidelines for Falls Prevention, participants will be stratified into low-, intermediate-, and high-risk groups. Following the first visit assessment, older adults classified as intermediate or high risk will be randomly assigned to one of two intervention groups: (1) a remotely delivered, smartphone- based Otago Exercise Program, or (2) an in-person, community-based Otago Exercise Program.
Participants in both groups will receive individualized 60-minute training sessions, two times per week for eight weeks. Across the sixteen training sessions, participants will receive a progressive balance, mobility, and strengthening program following the structure of the Otago Exercise Program.
Prior to and immediately following the exercise program, participants are asked to complete several surveys and evaluations, including: demographics, STEADI-12, SF-36, Geriatric Depression Scale (GDS), Falls Efficacy Scale-International (FES-I), Four-Square Stepping Test, Timed Up and Go Test (TUG), Ten-meter Walk Test, Four-Stage Balance Test, 30-second chair stand, and the Physiological Profile Assessment (PPA). All outcome measures will be collected at baseline and at the end of the intervention, with testers blinded to participant group allocation, and trainers blinded to baseline outcomes. In addition, gait speed will be assessed weekly using smartphone-based measurements.
346 studies on the registry are indexed under Gait Disorders, Neurologic; 54 are open to participants now.
This study's planned enrollment of 36 is above the median of 30 across 261 interventional studies indexed under Gait Disorders, Neurologic.
Browse Gait Disorders, Neurologic studies →Binghamton University is the lead sponsor of 12 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In-home 8-week OTAGO program
Behavioral: Smartphone-Based Intervention
In-Person 8-week Group OTAGO Program
Behavioral: Group-Based Intervention
Participants in the smartphone-based group will receive Otago Exercise Program instructions delivered through Improve, an investigator-developed application. This application, installed on each participant's iOS or Android smartphone, will allow participants to track their exercises and review workout instructions. Participants in the smartphone-based group will be contacted weekly by phone to ensure safety and adherence and to assist with troubleshooting any technology-related issues. All participants will be instructed to maintain their usual activity patterns and to refrain from initiating any new structured physical activity programs during the 8-week study period. Participants will be directed by Doctor of Physical Therapy students under the supervision of a licensed Physical Therapist, with weekly phone check-ins.
Also known as: Otago
Participants in the in-person, community-based group will complete the individualized Otago Exercise Program in a group setting at the Johnson City Senior Center, under the guidance of Doctor of Physical Therapy students (4) and supervision of licensed Physical Therapists.
Also known as: Otago
Gait Velocity
Self-selected walking speed (m/s) over level surface
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Injurious Falls
Self-reported falls that lead to injury requiring clinical evaluation
Time frame: Up to 1-year post intervention
PPA-Short Form: Postural Sway
Sway Area (units: mm\^2) while standing quietly for 30 seconds
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Finger Reaction Time
Simple reaction time (units: msec)
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Knee Extensor Strength
Maximum isometric knee extensor force (kg)
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Visual Contrast Sensitivity
Melbourne Contrast Sensitivity (db), on a scale of 0-24
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
PPA-Short Form: Proprioception
Degrees offset in foot positioning
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
30-second Chair Stand
Number of chair rises in 30-seconds
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
TUG
Timed up and go test. Rise from a chair, walk 3-meters, turn, and return walk, and sit back down at self-selected speed
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Four-Stage Balance
Total time to stand in side-to-side, semi-tandem, tandem, one-leg stance.
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Smartphone-based assessments
Self-evaluated walking speed as performed by participants at home
Time frame: Weekly during 8-week training program
Four square step test
Time to complete a clockwise and counterclockwise stepping into four quadrants
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Frailty
Physical Frailty Phenotype, reported on a scale of 0-5. A higher score indicates increased frailty.
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Self-reported Assessment: Enjoyment
Participant report of enjoyment, usability, and feasibility of the exercise program (1-5 scale), where higher scores indicate increased self-report.
Time frame: At study completion, or on average 1 week post-training
SF-36
Short-form health survey to evaluate participant self-reported health quality of life.
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
STEADI
Self-report (0 to 14-point scale), where increased scores indicate increased fall risk.
Time frame: Baseline (Day 0) and 1 week post-training (9 weeks later)
Plan to share: Undecided — No identifying information will be shared.
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 184 non-industry interventional studies with no phase under Gait Disorders, Neurologic, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 9 months is below that.
Counting every sponsor, half of 197 studies reached it within 14 months; a quarter within 5 and three quarters within 38.
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