Aging, Mobility Limitation
Conditions
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.
Interventions
DEVICEHome-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
DEVICESham 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.
Sponsors
National Institute on Aging (NIA)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
70 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed Change From Baseline | Measured at follow up visit (approximately three weeks after baseline) | Change in the fastest safe walking speed during a two minute walk test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed up and go Completion Time From Baseline | Measured at follow up visit (approximately three weeks after baseline) | Change in the time to complete a 7 meter timed up and go |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 17 |
| 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. | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Sham tDCS | Active tDCS |
|---|---|---|---|
| Activities-specific Balance Confidence (ABC) Scale | 86.46 units on a scale STANDARD_DEVIATION 11.09 | 86.3 units on a scale STANDARD_DEVIATION 12.59 | 86.6 units on a scale STANDARD_DEVIATION 9.75 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 17 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 79.35 years STANDARD_DEVIATION 4.8 | 81.0 years STANDARD_DEVIATION 5.04 | 77.7 years STANDARD_DEVIATION 4.06 |
| Body Mass Index (BMI) | 27.01 weight (kg) / [height (m)]2 STANDARD_DEVIATION 4.33 | 26.1 weight (kg) / [height (m)]2 STANDARD_DEVIATION 4.82 | 27.9 weight (kg) / [height (m)]2 STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants | 17 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 1.69 meters STANDARD_DEVIATION 0.11 | 1.68 meters STANDARD_DEVIATION 0.11 | 1.69 meters STANDARD_DEVIATION 0.12 |
| Katz Index of Independence | 5.94 units on a scale STANDARD_DEVIATION 0.24 | 5.9 units on a scale STANDARD_DEVIATION 0.33 | 6.0 units on a scale STANDARD_DEVIATION 0 |
| Mass | 77.23 kilograms STANDARD_DEVIATION 15.4 | 74.21 kilograms STANDARD_DEVIATION 16.53 | 80.26 kilograms STANDARD_DEVIATION 14.01 |
| Montreal Cognitive Assessment (MoCA) | 26.53 units on a scale STANDARD_DEVIATION 1.71 | 26.4 units on a scale STANDARD_DEVIATION 1.8 | 26.7 units on a scale STANDARD_DEVIATION 1.65 |
| Motor Imagery Questionnaire (MIQ-RS) | 6.21 units on a scale STANDARD_DEVIATION 0.82 | 6.1 units on a scale STANDARD_DEVIATION 0.75 | 6.3 units on a scale STANDARD_DEVIATION 0.89 |
| Movement-Specific Reinvestment Scale | 32.9 units on a scale STANDARD_DEVIATION 11 | 33.2 units on a scale STANDARD_DEVIATION 11.28 | 32.6 units on a scale STANDARD_DEVIATION 10.95 |
| Pittsburgh Sleep Quality Index (PSQI) | 5.74 units on a scale STANDARD_DEVIATION 2.54 | 6.2 units on a scale STANDARD_DEVIATION 2.96 | 5.3 units on a scale STANDARD_DEVIATION 2.02 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 16 Participants | 17 Participants |
| Region of Enrollment United States | 34 participants | 17 participants | 17 participants |
| Sex: Female, Male Female | 17 Participants | 9 Participants | 8 Participants |
| Sex: Female, Male Male | 17 Participants | 8 Participants | 9 Participants |
| Short Form-36 (SF-36): General Health Subscale | 75.6 units on a scale STANDARD_DEVIATION 13.01 | 75 units on a scale STANDARD_DEVIATION 13.11 | 76.2 units on a scale STANDARD_DEVIATION 13.29 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 0 / 17 | 0 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Walking Speed Change From Baseline
Change in the fastest safe walking speed during a two minute walk test
Time frame: Measured at follow up visit (approximately three weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Walking Speed Change From Baseline | 0.052 m/s | Standard Error 0.098 |
| Sham tDCS | Walking Speed Change From Baseline | -0.026 m/s | Standard Error 0.052 |
p-value: 0.012t-test, 2 sided
Comparison: Post-intervention changes in walking speed
Secondary
Timed up and go Completion Time From Baseline
Change in the time to complete a 7 meter timed up and go
Time frame: Measured at follow up visit (approximately three weeks after baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Timed up and go Completion Time From Baseline | -0.22 seconds | Standard Deviation 1.7 |
| Sham tDCS | Timed up and go Completion Time From Baseline | 0.31 seconds | Standard Deviation 1.73 |
p-value: 0.39t-test, 2 sided