Trial Outcomes & Findings for A Telerehabilitation Program for SCI (NCT NCT04977037)
NCT ID: NCT04977037
Last Updated: 2025-04-20
Results Overview
The Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline
Results posted on
2025-04-20
Participant Flow
Participant milestones
| Measure |
Active tDCS
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
7
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Telerehabilitation Program for SCI
Baseline characteristics by cohort
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 16.5 • n=93 Participants
|
45.8 years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
46.2 years
STANDARD_DEVIATION 14.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=93 Participants
|
7 participants
n=4 Participants
|
20 participants
n=27 Participants
|
|
Asia Impairment Scale Classification
A
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Asia Impairment Scale Classification
B
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Asia Impairment Scale Classification
C
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Asia Impairment Scale Classification
D
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Time Since Injury
|
84 Months
STANDARD_DEVIATION 104.2 • n=93 Participants
|
71 Months
STANDARD_DEVIATION 85.12 • n=4 Participants
|
79.89 Months
STANDARD_DEVIATION 96.41 • n=27 Participants
|
PRIMARY outcome
Timeframe: BaselineThe Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
|
64.9 score on a scale
Standard Deviation 25.5
|
58.3 score on a scale
Standard Deviation 31.1
|
PRIMARY outcome
Timeframe: 2 weeksThe Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
|
68 score on a scale
Standard Deviation 28.8
|
59.7 score on a scale
Standard Deviation 32.6
|
PRIMARY outcome
Timeframe: 6 weeksThe Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) assesses the integration of sensorimotor hand and upper limb impairment and function. GRASSP total score will be reported, and it ranges from 0 to 116, with a higher score indicating a higher level of arm and hand function.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=6 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Arm and Hand Function as Assessed by Score on the Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP)
|
72.1 score on a scale
Standard Deviation 28.3
|
57.7 score on a scale
Standard Deviation 37.7
|
SECONDARY outcome
Timeframe: Treatment Day 1- Day 10Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Adherence With the Therapy as Assessed by the Number of Sessions Participants Attended
|
9.6 sessions
Standard Deviation 0.65
|
9.0 sessions
Standard Deviation 1.73
|
SECONDARY outcome
Timeframe: Between enrollment and 6 weeksOutcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Adherence With the Therapy as Assessed by the Number of Participant Drop-outs
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 10Participants rated the usefulness of the interventions on a scale of 0 to 10, with 0 indicating not useful at all and 10 indicating very useful.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Usefulness of the Intervention as Assessed by the Visual Analog Scale (VAS)
|
9.1 score on a scale
Standard Deviation 1.3
|
9.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: BaselineMaximum force generated by hand muscles and measured with a hand-held dynamometer
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Grip Strength
|
19.2 pounds (lbs)
Standard Deviation 25.6
|
9.3 pounds (lbs)
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 2 weeksMaximum force generated by hand muscles and measured with a hand-held dynamometer
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Grip Strength
|
20.9 pounds (lbs)
Standard Deviation 25.7
|
10.8 pounds (lbs)
Standard Deviation 10.1
|
SECONDARY outcome
Timeframe: 6 weeksMaximum force generated by hand muscles and measured with a hand-held dynamometer
Outcome measures
| Measure |
Active tDCS
n=11 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=6 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Grip Strength
|
24.6 pounds (lbs)
Standard Deviation 31.5
|
11.3 pounds (lbs)
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: BaselineTotal score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
|
11.1 score on a scale
Standard Deviation 6.4
|
6.4 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: 2 weeksTotal score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
|
11.5 score on a scale
Standard Deviation 6.1
|
7.3 score on a scale
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: 6 weeksTotal score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III) ranges between 0 to 20, with a higher score indicating a higher level of independence in daily functions.
Outcome measures
| Measure |
Active tDCS
n=11 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=6 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Self Care as Assessed by Score on the Self Care Subscale of the Spinal Cord Injury Independence Measure (SCIM III)
|
11.6 score on a scale
Standard Deviation 6.1
|
7.5 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: from baseline to 6 weeksOutcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Number of Participants Who Had Adverse Events
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 10Participants rated the level of difficulty of using tDCS on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using tDCS as Assessed by the Visual Analog Scale (VAS)
|
1.1 score on a scale
Standard Deviation 1.3
|
1 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Day 10Participants rated the level of difficulty of using exercise equipment on a scale of 0 to 10, with 0 indicating not difficult at all and 10 indicating very difficult.
Outcome measures
| Measure |
Active tDCS
n=13 Participants
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 Participants
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Feasibility of Home Intervention as Indicated by Participants' Perceptions of Level of Difficulty of Using Exercise Equipment as Assessed by the Visual Analog Scale (VAS)
|
1.1 score on a scale
Standard Deviation 1.3
|
1.7 score on a scale
Standard Deviation 1.5
|
Adverse Events
Active tDCS
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active tDCS
n=13 participants at risk
Anodal transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Active tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
Sham tDCS
n=7 participants at risk
Sham transcranial direct current stimulation (tDCS) targeting the primary motor cortex delivered at 2mA for 20 minutes
Sham tDCS: Anodal tDCS will be placed over the primary motor cortex and delivered at 2mA for 20 minutes. Immediately after stimulation ceases, participants will continue with unilateral repetitive arm and finger exercises for 60 minutes. Exercise difficulty will gradually be increased and adjusted per participant's tolerance.
|
|---|---|---|
|
Renal and urinary disorders
Urinary Tract Infection (UTI)
|
0.00%
0/13 • up to 6 weeks
|
14.3%
1/7 • up to 6 weeks
|
|
Nervous system disorders
Autonomic Dysreflexia (AD)
|
0.00%
0/13 • up to 6 weeks
|
14.3%
1/7 • up to 6 weeks
|
|
Musculoskeletal and connective tissue disorders
Pelvic pain on right side
|
0.00%
0/13 • up to 6 weeks
|
14.3%
1/7 • up to 6 weeks
|
|
General disorders
Sick day during home therapy
|
7.7%
1/13 • up to 6 weeks
|
0.00%
0/7 • up to 6 weeks
|
Additional Information
Nuray Yozbatiran, PhD, PT
The University of Texas Health Sciences Center at Houston
Phone: 7137975282
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place