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

University of Florida

Status: Completed

Conditions: Aging; Mobility Limitation

Treatments: Device: Sham tDCS; Device: Home-based mobility testing and active tDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05583578

IRB202201802

P30AG028740 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 70 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups

Active tDCS

Experimental group

Description:

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).

Treatment:

Device: Home-based mobility testing and active tDCS

Sham tDCS

Sham Comparator group

Description:

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).

Treatment:

Device: Sham tDCS