Trial Outcomes & Findings for HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults (NCT NCT05583578)
NCT ID: NCT05583578
Last Updated: 2025-01-22
Results Overview
Change in the fastest safe walking speed during a two minute walk test
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Measured at follow up visit (approximately three weeks after baseline)
Results posted on
2025-01-22
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
15
|
17
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
HOMEStudy: Development of a Home-based Self-delivered Prehabilitation Intervention to Proactively Reduce Fall Risk in Older Adults
Baseline characteristics by cohort
| Measure |
Active tDCS
n=17 Participants
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).
|
Sham tDCS
n=17 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Continuous
|
77.7 years
STANDARD_DEVIATION 4.06 • n=5 Participants
|
81.0 years
STANDARD_DEVIATION 5.04 • n=7 Participants
|
79.35 years
STANDARD_DEVIATION 4.80 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Height
|
1.69 meters
STANDARD_DEVIATION 0.12 • n=5 Participants
|
1.68 meters
STANDARD_DEVIATION 0.11 • n=7 Participants
|
1.69 meters
STANDARD_DEVIATION 0.11 • n=5 Participants
|
|
Mass
|
80.26 kilograms
STANDARD_DEVIATION 14.01 • n=5 Participants
|
74.21 kilograms
STANDARD_DEVIATION 16.53 • n=7 Participants
|
77.23 kilograms
STANDARD_DEVIATION 15.40 • n=5 Participants
|
|
Body Mass Index (BMI)
|
27.9 weight (kg) / [height (m)]2
STANDARD_DEVIATION 3.70 • n=5 Participants
|
26.1 weight (kg) / [height (m)]2
STANDARD_DEVIATION 4.82 • n=7 Participants
|
27.01 weight (kg) / [height (m)]2
STANDARD_DEVIATION 4.33 • n=5 Participants
|
|
Montreal Cognitive Assessment (MoCA)
|
26.7 units on a scale
STANDARD_DEVIATION 1.65 • n=5 Participants
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26.4 units on a scale
STANDARD_DEVIATION 1.80 • n=7 Participants
|
26.53 units on a scale
STANDARD_DEVIATION 1.71 • n=5 Participants
|
|
Activities-specific Balance Confidence (ABC) Scale
|
86.6 units on a scale
STANDARD_DEVIATION 9.75 • n=5 Participants
|
86.3 units on a scale
STANDARD_DEVIATION 12.59 • n=7 Participants
|
86.46 units on a scale
STANDARD_DEVIATION 11.09 • n=5 Participants
|
|
Motor Imagery Questionnaire (MIQ-RS)
|
6.3 units on a scale
STANDARD_DEVIATION 0.89 • n=5 Participants
|
6.1 units on a scale
STANDARD_DEVIATION 0.75 • n=7 Participants
|
6.21 units on a scale
STANDARD_DEVIATION 0.82 • n=5 Participants
|
|
Katz Index of Independence
|
6.0 units on a scale
STANDARD_DEVIATION 0 • n=5 Participants
|
5.9 units on a scale
STANDARD_DEVIATION 0.33 • n=7 Participants
|
5.94 units on a scale
STANDARD_DEVIATION 0.24 • n=5 Participants
|
|
Movement-Specific Reinvestment Scale
|
32.6 units on a scale
STANDARD_DEVIATION 10.95 • n=5 Participants
|
33.2 units on a scale
STANDARD_DEVIATION 11.28 • n=7 Participants
|
32.9 units on a scale
STANDARD_DEVIATION 11.0 • n=5 Participants
|
|
Pittsburgh Sleep Quality Index (PSQI)
|
5.3 units on a scale
STANDARD_DEVIATION 2.02 • n=5 Participants
|
6.2 units on a scale
STANDARD_DEVIATION 2.96 • n=7 Participants
|
5.74 units on a scale
STANDARD_DEVIATION 2.54 • n=5 Participants
|
|
Short Form-36 (SF-36): General Health Subscale
|
76.2 units on a scale
STANDARD_DEVIATION 13.29 • n=5 Participants
|
75 units on a scale
STANDARD_DEVIATION 13.11 • n=7 Participants
|
75.6 units on a scale
STANDARD_DEVIATION 13.01 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Change in the fastest safe walking speed during a two minute walk test
Outcome measures
| Measure |
Active tDCS
n=15 Participants
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
|
Sham tDCS
n=17 Participants
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.
|
|---|---|---|
|
Walking Speed Change From Baseline
|
0.052 m/s
Standard Error 0.098
|
-0.026 m/s
Standard Error 0.052
|
SECONDARY outcome
Timeframe: Measured at follow up visit (approximately three weeks after baseline)Change in the time to complete a 7 meter timed up and go
Outcome measures
| Measure |
Active tDCS
n=15 Participants
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
|
Sham tDCS
n=17 Participants
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.
|
|---|---|---|
|
Timed up and go Completion Time From Baseline
|
-0.22 seconds
Standard Deviation 1.70
|
0.31 seconds
Standard Deviation 1.73
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place