Trial Outcomes & Findings for Enhancing Corticospinal Activation for Improved Walking Function (NCT NCT03237234)
NCT ID: NCT03237234
Last Updated: 2022-01-12
Results Overview
Walking speed was the primary outcome measure for walking function, as speed has been the standard measure used in the literature and allowed us to assess outcomes relative to other published studies. Walking speed was determined using the 10-Meter Walk Test. Participants completed 3 walk trials at each time point, separated by 2 minutes of seated rest. The average walking speed of 3 walks was calculated and used in the analyses. Data reported were obtained at baseline at Day 1 (D1) and at follow-up on Day 5 (D5), 24-hours post-intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
25 participants
Primary outcome timeframe
D1, D5
Results posted on
2022-01-12
Participant Flow
Participant milestones
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
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Motor Skill Training + tDCS (MST+tDCS)
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
MST: Motor skill training will consist of activities performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA.
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|---|---|---|
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Overall Study
STARTED
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14
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11
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Overall Study
COMPLETED
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14
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11
|
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (sham-tDCS).
MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (tDCS) delivered at 2mA to the motor cortex.
MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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Total
n=25 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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46.7 years
STANDARD_DEVIATION 15 • n=14 Participants
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50.5 years
STANDARD_DEVIATION 10.7 • n=11 Participants
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48.4 years
STANDARD_DEVIATION 13.2 • n=25 Participants
|
|
Sex: Female, Male
Female
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4 Participants
n=14 Participants
|
3 Participants
n=11 Participants
|
7 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=14 Participants
|
8 Participants
n=11 Participants
|
18 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
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—
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—
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0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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14 participants
n=14 Participants
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11 participants
n=11 Participants
|
25 participants
n=25 Participants
|
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10 Meter Walk Test (walk speed)
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0.72 m/sec
STANDARD_DEVIATION 0.53 • n=14 Participants
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0.64 m/sec
STANDARD_DEVIATION 0.51 • n=11 Participants
|
0.69 m/sec
STANDARD_DEVIATION 0.51 • n=25 Participants
|
|
Spatiotemporal Gait Characteristic (Cadence)
|
73.9 strides/min
STANDARD_DEVIATION 34.3 • n=14 Participants
|
70.7 strides/min
STANDARD_DEVIATION 38.5 • n=11 Participants
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72.5 strides/min
STANDARD_DEVIATION 35.5 • n=25 Participants
|
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Spatiotemporal Gait Characteristic (symmetry index)
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14.6 Absolute %
STANDARD_DEVIATION 12.2 • n=14 Participants
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12.3 Absolute %
STANDARD_DEVIATION 7.4 • n=11 Participants
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13.6 Absolute %
STANDARD_DEVIATION 10.2 • n=25 Participants
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Spatiotemporal Gait Characteristic (stride length -weaker limb)
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106.6 cm
STANDARD_DEVIATION 33.5 • n=14 Participants
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95.0 cm
STANDARD_DEVIATION 33.4 • n=11 Participants
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101.5 cm
STANDARD_DEVIATION 33.3 • n=25 Participants
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|
Spatiotemporal Gait Characteristic (stride length - stronger limb)
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106.8 cm
STANDARD_DEVIATION 33.1 • n=14 Participants
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94.4 cm
STANDARD_DEVIATION 32.9 • n=11 Participants
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101.3 cm
STANDARD_DEVIATION 33.0 • n=25 Participants
|
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Ankle Dorsiflexor Strength (MVC force)
|
61.9 lbs
STANDARD_DEVIATION 35.3 • n=14 Participants
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66.1 lbs
STANDARD_DEVIATION 19.9 • n=11 Participants
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63.8 lbs
STANDARD_DEVIATION 29.0 • n=25 Participants
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PRIMARY outcome
Timeframe: D1, D5Walking speed was the primary outcome measure for walking function, as speed has been the standard measure used in the literature and allowed us to assess outcomes relative to other published studies. Walking speed was determined using the 10-Meter Walk Test. Participants completed 3 walk trials at each time point, separated by 2 minutes of seated rest. The average walking speed of 3 walks was calculated and used in the analyses. Data reported were obtained at baseline at Day 1 (D1) and at follow-up on Day 5 (D5), 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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|---|---|---|
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10 Meter Walk Test (Walk Speed)
Day 1 (D1)
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0.72 m/sec
Standard Deviation 0.53
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0.64 m/sec
Standard Deviation 0.51
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10 Meter Walk Test (Walk Speed)
Day 5 (D5)
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0.85 m/sec
Standard Deviation 0.56
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0.78 m/sec
Standard Deviation 0.46
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SECONDARY outcome
Timeframe: D1, D5Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Cadence for each walk trial was computed using the GAITRite system, and the average cadence across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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|---|---|---|
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Spatiotemporal Gait Characteristic (Cadence)
Day 1 (D1)
|
73.9 strides/min
Standard Deviation 34.3
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70.7 strides/min
Standard Deviation 38.5
|
|
Spatiotemporal Gait Characteristic (Cadence)
Day 5 (D5)
|
81.5 strides/min
Standard Deviation 34.9
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82.1 strides/min
Standard Deviation 34.9
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SECONDARY outcome
Timeframe: D1, D5Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the weaker limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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|---|---|---|
|
Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb)
Day 1 (D1)
|
106.6 cm
Standard Deviation 33.5
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95.0 cm
Standard Deviation 33.4
|
|
Spatiotemporal Gait Characteristic (Stride Length - Weaker Limb)
Day 5 (D5)
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114.7 cm
Standard Deviation 35.6
|
104.5 cm
Standard Deviation 27.8
|
SECONDARY outcome
Timeframe: D1, D5Gait quality was quantified by spatiotemporal gait characteristics (cadence \[strides/min\], stride length \[cm\] and step length \[cm\] of the weaker and stronger limbs) collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average stride length of the stronger limb for each walk trial was computed from data obtained from the GAITRite system, and the average stride length across three walks was used in the analyses. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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|---|---|---|
|
Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb)
Day 1 (D1)
|
106.7 cm
Standard Deviation 33.1
|
94.4 cm
Standard Deviation 32.9
|
|
Spatiotemporal Gait Characteristic (Stride Length - Stronger Limb)
Day 5 (D5)
|
114.5 cm
Standard Deviation 35.5
|
103.7 cm
Standard Deviation 28.0
|
SECONDARY outcome
Timeframe: D1, D5Step length \[cm\] of the weaker and stronger limbs were collected via instrumented walkway (GAITRite, CIR Systems Inc., NJ, USA) as participants completed three, 10-Meter Walk Test trials at each time point. Average step length of each lower limb for each walk trial was computed from data obtained from the GAITRite system. Lower limbs were classified as stronger or weaker according to manual muscle test scores collected at baseline (D1). The average step length for the stronger and weaker limbs was used to calculate the step symmetry index (SI) using the following formula: SI = ((SLs - SLw)/0.5(SLs + SLw)) x 100; where SLs = stronger limb stride length and SLw = weaker limb stride length. Final values are reported as the absolute % of the ratio difference in step length between the stronger and weaker limbs. A SI value of 0% indicates perfect interlimb step symmetry. Higher SI values indicate greater interlimb step length asymmetry.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
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|---|---|---|
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Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Day 1 (D1)
|
14.6 Absolute % of step length diff ratio
Standard Deviation 12.2
|
12.3 Absolute % of step length diff ratio
Standard Deviation 7.4
|
|
Spatiotemporal Gait Characteristic (Step Length Symmetry - Symmetry Index)
Day 5 (D5)
|
16.2 Absolute % of step length diff ratio
Standard Deviation 20.8
|
13.6 Absolute % of step length diff ratio
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: D1, D5Ankle dorsiflexion (tibialis anterior) strength was measured with the subject seated and with the test foot strapped to a handheld dynamometer. An ankle dorsiflexion test was selected based on evidence indicating that the tibialis anterior is under the greatest corticospinal control. Maximum dorsiflexion force was calculated based on the highest force measured over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Maximal Isometric Dorsiflexor Strength
Day 1 (D1)
|
57.7 lbs
Interval 34.4 to 72.8
|
68.3 lbs
Interval 57.3 to 82.0
|
|
Maximal Isometric Dorsiflexor Strength
Day 5 (D5)
|
49.3 lbs
Interval 31.8 to 64.5
|
72.9 lbs
Interval 57.6 to 92.9
|
SECONDARY outcome
Timeframe: D1, D5Balance was measured using the Berg Balance Scale (BBS), which has been found to be valid for use in persons with SCI. The BBS total score was calculated for each participant at each time point, and the median score for each group was calculated. The total range of scores for the BBS equals 0-56, with higher scores from baseline indicating greater balance performance and lower scores from baseline indicating worsened balance performance. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Berg Balance Scale
Day 1 (D1)
|
38.0 score on a scale
Interval 25.5 to 50.8
|
46.0 score on a scale
Interval 39.0 to 51.0
|
|
Berg Balance Scale
Day 5 (D5)
|
41.5 score on a scale
Interval 29.3 to 46.8
|
49.0 score on a scale
Interval 39.5 to 54.0
|
SECONDARY outcome
Timeframe: D1, D5The fear of falling may be a major concern for persons with mobility impairments and may limit one's confidence or ability to perform activities of daily living. Fear of falling may also limit an individual's performance of specific overground motor tasks irrespective of functional ability to perform that task. Therefore, the fear of falling was an important factor to consider relative to the mobility interventions employed in the present study. The FES-I total score was calculated for each participant at each time point, and the median for each group was recorded. The total range of scores possible for the FES-I is equal to 16-64, with lower total scores indicating decreased fear of falling. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Falls Efficacy Scale-International Version (FES-I)
Day 1 (D1)
|
34.0 score on a scale
Interval 29.3 to 40.0
|
33.0 score on a scale
Interval 30.5 to 43.5
|
|
Falls Efficacy Scale-International Version (FES-I)
Day 5 (D5)
|
33.5 score on a scale
Interval 28.5 to 36.8
|
28.0 score on a scale
Interval 26.0 to 43.5
|
SECONDARY outcome
Timeframe: D1, D5The Spinal Cord Assessment Tool for Spastic Reflexes (SCATS) was used to assess the impact of motor skill training + sham stimulation and motor training + tDCS on spasticity. SCATS is well correlated with electrophysiological measures of spasticity and is better correlated with self-reported measures of spasm frequency than the Ashworth test. Total SCATS scores for each limb were summed and median values were obtained for each group. The total range of scores possible for the SCATS is 0-18, with a total score of 0 indicating no lower limb spasticity and higher total scores indicating greater spasticity severity. Data reported were obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Spinal Cord Assessment Tool for Spastic Reflexes
Day 1 (D1)
|
4.0 score on a scale
Interval 2.0 to 7.5
|
4.0 score on a scale
Interval 2.0 to 6.5
|
|
Spinal Cord Assessment Tool for Spastic Reflexes
Day 5 (D5)
|
6.0 score on a scale
Interval 3.5 to 7.0
|
4.0 score on a scale
Interval 1.0 to 7.0
|
SECONDARY outcome
Timeframe: D1, D5The modified 5-times sit-to-stand test was used as a measure of functional lower extremity strength. In this test, the participant was seated on a mat table with height adjusted to 80% of lower extremity length. The time required to complete 5 repetitions of standing up and sitting down (without using the upper extremities for assistance) was recorded. The average time to complete the test was calculated at each time point for each group. Lower sit-to-stand times indicate greater functional lower extremity strength. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Modified 5-Times Sit-to-Stand
Day 1 (D1)
|
13.7 seconds
Standard Deviation 5.2
|
21.9 seconds
Standard Deviation 17.3
|
|
Modified 5-Times Sit-to-Stand
Day 5 (D5)
|
14.9 seconds
Standard Deviation 7.3
|
19.6 seconds
Standard Deviation 15.8
|
SECONDARY outcome
Timeframe: D1, D5Knee extensor (quadriceps) strength was measured with participants seated, with the test leg strapped to a handheld dynamometer. Prior studies have shown that a single session of tDCS improves quadriceps strength in persons with stroke. Maximum knee extensor force was analyzed based on the maximum force produced over three attempts. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
Maximal Isometric Quadriceps Strength
Day 1 (D1)
|
86.7 lbs
Interval 63.6 to 114.3
|
92.1 lbs
Interval 78.5 to 118.1
|
|
Maximal Isometric Quadriceps Strength
Day 5 (D5)
|
84.4 lbs
Interval 52.5 to 90.4
|
103.5 lbs
Interval 85.4 to 131.9
|
SECONDARY outcome
Timeframe: D1, D5Functional walking capacity was measured based on 2-minute walk test distance. The use of the 2-minute rather than the 6-minute walk test allowed us to include individuals whose impairments result in inability to walk for 6 minutes. Total distance walked in 2-minutes was recorded for each participant at each time point, and the average distance was calculated for each group. Results are reported for data obtained at baseline Day-1 (D1) and at follow-up on Day-5, 24-hours post-intervention.
Outcome measures
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 Participants
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
2 Minute Walk Test
Day 1 (D1)
|
83.1 m
Standard Deviation 49.4
|
77.1 m
Standard Deviation 55.3
|
|
2 Minute Walk Test
Day 5 (D5)
|
93.7 m
Standard Deviation 50.3
|
86.7 m
Standard Deviation 50.7
|
Adverse Events
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Motor Skill Training + tDCS (MST+tDCS)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Motor Skill Training + Sham tDCS (MST+Sham-tDCS)
n=14 participants at risk
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training while receiving sham transcranial direct current stimulation (MST+sham-tDCS).
MST: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
|
Motor Skill Training + tDCS (MST+tDCS)
n=11 participants at risk
Individuals will participate in 3 consecutive sessions of lower extremity motor skill training combined with transcranial direct current stimulation (MST+tDCS) delivered at 2mA to the motor cortex.
Motor Skill Training: Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MST, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
Transcranial direct current stimulation (tDCS): The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MST activities.
|
|---|---|---|
|
General disorders
Mild Headache
|
0.00%
0/14 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
27.3%
3/11 • Number of events 3 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
|
General disorders
Moderate Headache
|
7.1%
1/14 • Number of events 1 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
0.00%
0/11 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle Soreness
|
0.00%
0/14 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
18.2%
2/11 • Number of events 2 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Suprapubic Catheter Irritation
|
0.00%
0/14 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
9.1%
1/11 • Number of events 1 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Thumb Blister
|
7.1%
1/14 • Number of events 1 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
0.00%
0/11 • Adverse event queries and documentation were performed for each participant beginning at baseline on Day 1 and concluding following the last day of data collection on Day 5, which is the time course over which participants were enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place