HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults

Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults

Older adults often have difficulty performing complex walking tasks leading to increased fall incidence and subsequent injury. Even in the best clinical settings, it may not be possible for patients or clinicians to dedicate the time and financial resources needed to enact lasting improvements. The study will investigate the use of non-invasive brain stimulation and motor imagery practice within participants homes to assess study design feasibility and potential for mobility improvement.

Study Overview

• Status: Completed
• Conditions: Aging; Mobility Limitation
• Intervention / Treatment: Device: Home-based mobility testing and active tDCS; Device: Sham tDCS

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years to 95 years (Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 70 - 95 years of age
• Self-report having a risk of falling. Fall risk will be determined by asking whether the participant has had (and recovered from) a fall related injury in the previous year or had fallen two or more times in the previous year or if the participant is afraid of falling because of their balance or walking. (This criterion is based on the 2020 NEJM study: "A Randomized Trial of a Multifactorial Strategy to Prevent Serious Fall Injuries")
• Self-report of "some difficulty with walking tasks, such as becoming tired when walking a quarter mile, or when climbing two flights of stairs, or when performing household chores."
• Willingness to be randomized to either study group and to participate in all aspects of the study assessment and intervention.
• Living in the community and able to travel to the research site.
• Ability to independently assemble and put on the tDCS headband or incorporate the involvement of a willing study partner (e.g., a spouse, family member, or friend) who agrees to assist with this task during each home intervention session.
• Access to an internet-connected computer or television capable of playing videos with sound located in a quiet area with a comfortable stationary chair.
• Able to provide informed consent.

Exclusion Criteria:

• Diagnosed neurological disorder or injury of the central nervous system, or observation of symptoms consistent with such a condition (spinal cord injury, Alzheimer's, Parkinson's, stroke, etc.)
• A score of 23 or lower on the Montreal Cognitive Assessment (MoCA)
• Contraindications to non-invasive brain stimulation (e.g., metal in head, wound on scalp)
• Use of medications affecting the central nervous system including, but not limited to, benzodiazepines, anti-cholinergic medications, and GABAergic medications.
• Severe arthritis, such as awaiting joint replacement
• Current cardiovascular, lung or renal disease; diabetes; terminal illness
• Myocardial infarction or major heart surgery in the previous year
• Cancer treatment in the past year, except for nonmelanoma skin cancers and cancers having an excellent prognosis (e.g., early-stage breast or prostate cancer)
• Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder
• Difficulty communicating with study personnel (including people who cannot speak English)
• Uncontrolled hypertension at rest (systolic > 180 mmHg and/or diastolic > 100 mmHg)
• Bone fracture or joint replacement in the previous six months
• Current participation in physical therapy for lower extremity function or cardiopulmonary rehabilitation
• Current enrollment in any clinical trial
• Clinical judgment of investigative team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active tDCS; Twenty minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm2 sponges placed over the frontal cortices at F3 and F4 (based on the international "10-20 system" of standardized brain electrode placement).	Device: Home-based mobility testing and active tDCS; A Soterix Clinical Trials tDCS unit will be used for delivery of stimulation for twenty minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm2 sponges placed over the frontal cortices at F3 and F4 (based on the international "10-20 system" of standardized brain electrode placement). 2.0mA was
Sham Comparator: Sham tDCS; 30 seconds (at the beginning and end of 20 minutes) of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm2 sponges placed over the frontal cortices at F3 and F4 (based on the international "10-20 system" of standardized brain electrode placement).	Device: Sham tDCS; Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2.0mA of direct current stimulation at the beginning of each rehabilitation session. Since participants habituate to the sensation of tDCS within 30-60 seconds of stimulation, this procedure provides the same sensation of active tDCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed Change From Baseline	Change in the fastest safe walking speed during a two minute walk test	Measured at follow up visit (approximately three weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go Completion Time From Baseline	Change in the time to complete a 7 meter timed up and go	Measured at follow up visit (approximately three weeks after baseline)

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Clayton Swanson, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): February 7, 2024

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Mobility Limitation
• Other Study ID Numbers: IRB202201802; P30AG028740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No