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

NCT05583578 | Completed Results FDA Device

• 2 other identifiers: IRB202201802P30AG028740
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobility Limitation; Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Timed up and go Completion Time From Baseline

  Measured at follow up visit (approximately three weeks after baseline)

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

Home-based mobility testing and active tDCS DEVICE

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

Active tDCS

Sham tDCS DEVICE

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.

Sham tDCS

Eligibility Criteria

• Age: 70 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Swanson CW, Vial SE, Manini TM, Sibille KT, Clark DJ. Protocol for a home-based self-delivered prehabilitation intervention to proactively reduce fall risk in older adults: a pilot randomized controlled trial of transcranial direct current stimulation and motor imagery. Pilot Feasibility Stud. 2024 Jun 14;10(1):89. doi: 10.1186/s40814-024-01516-1.

  PMID: 38877595 DERIVED

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This pilot study was primarily designed to evaluate the feasibility and acceptability of a home-based, self-delivered motor imagery intervention for older adults at risk of falling. Consequently, the primary outcomes-changes in walking speed and time to complete the Timed Up and Go (TUG) test-were not intended for inferential statistical analysis. Instead, they were analyzed to provide variance estimates and effect sizes to guide the design of a future follow-up investigation.

Results Point of Contact

• Title: Dr. Clayton Swanson
• Organization: University of Florida

clayton.swanson@ufl.edu

3522735919

Study Officials

• Clayton Swanson

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 17, 2022
• Study Start: January 1, 2023
• Primary Completion: January 31, 2024
• Study Completion: February 7, 2024
• Last Updated: January 22, 2025
• Results First Posted: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)