NCT05583578

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 70 Years – 95 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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
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.

Timeline

• Start date: 2023-01-01
• Primary completion: 2024-01-31
• Completion: 2024-02-07
• First posted: 2022-10-17
• Last updated: 2025-01-22
• Results posted: 2025-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study