Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P30AG028740 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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) |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Clayton Swanson | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38877595 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active tDCS | A Soterix mini Clinical Trials tDCS unit will be used for delivery of active stimulation. Participants received 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2023 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| FG001 | Sham tDCS | A Soterix mini Clinical Trials tDCS unit was used for delivery of sham stimulation. Participants received 30 seconds of 2.0mA of direct current stimulation at the beginning of each 20 minute session. Since participants habituate to the sensation of tDCS within 30-60 seconds of stimulation, this procedure provides the same sensation of active tDCS while only receiving 30 seconds of stimulation at the beginning and end. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS | A Soterix mini Clinical Trials tDCS unit will be used for delivery of active stimulation. Participants received 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). |
| BG001 | Sham tDCS | A Soterix mini Clinical Trials tDCS unit was used for delivery of sham stimulation. Participants received 30 seconds of 2.0mA of direct current stimulation at the beginning of each 20 minute session. Since participants habituate to the sensation of tDCS within 30-60 seconds of stimulation, this procedure provides the same sensation of active tDCS while only receiving 30 seconds of stimulation at the beginning and end. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Height | Mean | Standard Deviation | meters |
| |||||||||||||||||
| Mass | Mean | Standard Deviation | kilograms |
| |||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | weight (kg) / [height (m)]2 |
| |||||||||||||||||
| Montreal Cognitive Assessment (MoCA) | Name: Montreal Cognitive Assessment Abbreviation: MoCA Construct: The MoCA measures global cognitive function. Scale Range: 0 to 30 Interpretation: Higher scores indicate better cognitive function, while lower scores suggest greater cognitive impairment. A score of 26 or higher is typically considered normal, while lower scores may indicate mild cognitive impairment or more severe deficits. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Activities-specific Balance Confidence (ABC) Scale | Name: Activities-specific Balance Confidence Scale Abbreviation: ABC Scale Construct: Assesses an individual's confidence in performing various ambulatory activities without losing balance or becoming unsteady. Scale Range: 0% to 100% (each item is rated 0-100, and an average percentage score is calculated) Interpretation: Higher scores indicate greater balance confidence, while lower scores suggest lower balance confidence and possible fear of falling. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Motor Imagery Questionnaire (MIQ-RS) | Name: Motor Imagery Questionnaire - Revised Second Version Abbreviation: MIQ-RS Construct: Assesses the ease with which individuals can perform motor imagery tasks in both visual and kinesthetic modalities. Scale Range: 7-point Likert scale from 1 = very hard to see/feel to 7 = very easy to see/feel Interpretation: Higher scores indicate better ability to engage in motor imagery, while lower scores indicate difficulty in performing mental imagery tasks. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Katz Index of Independence | Name: Katz Index of Independence in Activities of Daily Living Abbreviation: Katz Index Construct: Measures an individual's independence in performing basic activities of daily living (ADLs), such as bathing, dressing, toileting, transferring, continence, and feeding. Scale Range: 0 to 6 (1 point per independent activity) Interpretation: Higher scores indicate greater independence, while lower scores suggest higher dependence in performing ADLs. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Movement-Specific Reinvestment Scale | Name: Movement-Specific Reinvestment Scale Abbreviation: MSRS Construct: Assesses the extent to which an individual consciously monitors and controls their movements, potentially disrupting automaticity of movement. Scale Range: 10 to 50 (each item is rated on a 5-point Likert scale from 1 = strongly disagree to 5 = strongly agree) Interpretation: Higher scores indicate a higher tendency for conscious movement control, which may be associated with poorer movement performance, particularly under pressure. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Pittsburgh Sleep Quality Index (PSQI) | Name: Pittsburgh Sleep Quality Index Abbreviation: PSQI Construct: Assesses sleep quality and disturbances over a 1-month period across several domains, including sleep duration, latency, efficiency, disturbances, medication use, and daytime dysfunction. Scale Range: 0 to 21 (global score based on 7 components, each scored 0-3) Interpretation: Higher scores indicate worse sleep quality, with a global score greater than 5 suggesting significant sleep disturbances or poor sleep quality. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||||
| Short Form-36 (SF-36): General Health Subscale | Name: Short Form-36 Health Survey Abbreviation: SF-36 Subscale: General Health Construct: Assesses perceptions of overall health, including personal health status and expectations of future health. Subscale Range: 0 to 100 (calculated by transforming raw scores) Interpretation: Higher scores indicate better perceived general health, while lower scores indicate poorer perceived general health. Scoring Information: The General Health subscale is calculated by via five items related to overall health perception. The SF-36 does not compute an overall score but eight individual subscales. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Walking Speed Change From Baseline | Change in the fastest safe walking speed during a two minute walk test | Posted | Mean | Standard Error | m/s | Measured at follow up visit (approximately three weeks after baseline) |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Timed up and go Completion Time From Baseline | Change in the time to complete a 7 meter timed up and go | Posted | Mean | Standard Deviation | seconds | Measured at follow up visit (approximately three weeks after baseline) |
|
|
The duration in which participants were enrolled in the study to when they completed all study procedures (3 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). 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 | 0 | 17 | 0 | 17 | 0 | 17 |
| EG001 | 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). 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. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Clayton Swanson | University of Florida | 3522735919 | clayton.swanson@ufl.edu |
| Dec 12, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2023 | Jun 24, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Cohen's d (effect size) |
| 0.98 |
| 2-Sided |
Effect sizes greater than (d = 0.80) were considered large. |
| Other |
|
|