Trial Outcomes & Findings for Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI (NCT NCT02862080)
NCT ID: NCT02862080
Last Updated: 2021-01-20
Results Overview
This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
COMPLETED
NA
4 participants
beginning and end of first no-intervention visit (7 days before any intervention)
2021-01-20
Participant Flow
Participant milestones
| Measure |
no Intervention; Then no Intervention; Then Cathode tsDCS + Ekso; Then Ekso; Then Cathode tsDCS+Ekso
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
|
no Intervention; Then no Intervention; Then Ekso; Then Cathode tsDCS + Ekso; Then Ekso
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Cathode tsDCS + Ekso will combine the use of cathode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
cathode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
|
no Intervention; Then no Intervention; Then Anode tsDCS + Ekso; Then Ekso; Then Anode tsDCS + Ekso
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
|
no Intervention; Then no Intervention; Then Ekso; Then Anode tsDCS + Ekso; Then Ekso
Non-invasive transcutaneous spinal direct current stimulation (tsDCS) applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Anode tsDCS + Ekso will combine the use of anode tsDCS application followed by a walking session in Ekso. Ekso will consist of a walking session in Ekso with no tsDCS.
Ekso: Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
anode tsDCS: Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
|
|---|---|---|---|---|
|
7 Days Before Any Intervention
STARTED
|
1
|
1
|
1
|
1
|
|
7 Days Before Any Intervention
COMPLETED
|
1
|
1
|
1
|
1
|
|
7 Days Before Any Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
3 Days Before Any Intervention
STARTED
|
1
|
1
|
1
|
1
|
|
3 Days Before Any Intervention
COMPLETED
|
1
|
1
|
1
|
1
|
|
3 Days Before Any Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 1 (1 Week)
STARTED
|
1
|
1
|
1
|
1
|
|
Intervention 1 (1 Week)
COMPLETED
|
1
|
1
|
1
|
1
|
|
Intervention 1 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (1 Week)
STARTED
|
1
|
1
|
1
|
1
|
|
Washout (1 Week)
COMPLETED
|
1
|
1
|
1
|
1
|
|
Washout (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 2 (1 Week)
STARTED
|
1
|
1
|
1
|
1
|
|
Intervention 2 (1 Week)
COMPLETED
|
1
|
1
|
1
|
1
|
|
Intervention 2 (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Intervention 1 Again (1 Week)
STARTED
|
1
|
1
|
1
|
1
|
|
Intervention 1 Again (1 Week)
COMPLETED
|
1
|
1
|
1
|
1
|
|
Intervention 1 Again (1 Week)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combining tsDCS and Exoskeleton Gait Training on Spinal Excitability in SCI
Baseline characteristics by cohort
| Measure |
Ekso Alone, and Ekso + Cathode tsDCS
n=2 Participants
Participants received Ekso alone and also Ekso combined with cathode non-invasive transcutaneous spinal direct current stimulation (tsDCS).
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso alone will consist of a walking session in Ekso with no tsDCS. Cathode tsDCS plus Ekso involves cathode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone, and Ekso + Anode tsDCS
n=2 Participants
Participants received Ekso alone and also Ekso combined with anode non-invasive transcutaneous spinal direct current stimulation (tsDCS).
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Ekso alone will consist of a walking session in Ekso with no tsDCS. Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 12.7 • n=5 Participants
|
37 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
39.5 years
STANDARD_DEVIATION 9.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 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
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Level of Spinal Cord Injury (SCI)
T1
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Level of Spinal Cord Injury (SCI)
T9
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Level of Spinal Cord Injury (SCI)
C5
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Time since injury
|
16.5 years
STANDARD_DEVIATION 16.26 • n=5 Participants
|
6 years
STANDARD_DEVIATION 1.41 • n=7 Participants
|
11.25 years
STANDARD_DEVIATION 11.21 • n=5 Participants
|
PRIMARY outcome
Timeframe: beginning and end of first no-intervention visit (7 days before any intervention)Population: All participants were assessed for the H-Reflex at this visit.
This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Outcome measures
| Measure |
No Intervention
n=4 Participants
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Change in Spinal Cord Excitability as Measured by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
|
-3.13 percent change in H-Reflex
Standard Deviation 18.27
|
—
|
—
|
PRIMARY outcome
Timeframe: beginning and end of second no-intervention visit (3 days before any intervention)Population: All participants were assessed for the H-Reflex at this visit.
This visit includes assessment of soleus H-Reflex on arrival and 40 minutes after the initial assessment--change between these two readings is reported. Subjects will be asked to minimize their activity between the two assessments by either sitting in a chair or lying on a mat. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Outcome measures
| Measure |
No Intervention
n=4 Participants
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
|
-5.74 percent change in H-Reflex
Standard Deviation 10.96
|
—
|
—
|
PRIMARY outcome
Timeframe: before and after intervention on day 1Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Outcome measures
| Measure |
No Intervention
n=3 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=6 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
|
4.52 percent change in H-Reflex
Standard Deviation 6.47
|
11.19 percent change in H-Reflex
Standard Deviation 37.94
|
2.71 percent change in H-Reflex
Standard Deviation 13.06
|
PRIMARY outcome
Timeframe: before and after intervention on day 5Population: All participants received all interventions as assigned during all 3 intervention periods and were assessed for H-reflex. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
Soleus H-Reflex is assessed on arrival and then after the intervention is applied--change between these two readings is reported. The H-reflex is a reaction of muscles after electrical stimulation (this stimulation is not the intervention, but is instead part of the H-reflex assessment). H-reflex will be elicited by placing the cathode of an electrical stimulator in the popliteal fossa (a shallow depression located at the back of the knee joint) and stimulating the tibial nerve. To record the electrical-induced muscle activity (that is, to measure H-reflexes), surface electromyography electrodes will be placed at the soleus muscle of the testing leg.
Outcome measures
| Measure |
No Intervention
n=3 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=6 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Change in Spinal Cord Excitability as Assessed by Percent Change in Soleus H-Reflex From Beginning of Session to End of the Same Session
|
-2.30 percent change in H-Reflex
Standard Deviation 2.65
|
-7.44 percent change in H-Reflex
Standard Deviation 24.82
|
-9.82 percent change in H-Reflex
Standard Deviation 9.73
|
SECONDARY outcome
Timeframe: first no-intervention visit (7 days before any intervention)Population: All participants were assessed for the 10MWT at this visit.
The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=4 Participants
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
37.14 seconds
Standard Deviation 20.25
|
—
|
—
|
SECONDARY outcome
Timeframe: second no-intervention visit (3 days before any intervention)Population: One participant was not assessed for gait speed at this visit.
The 10 Meter Walk Test (10MWT) will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=3 Participants
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
27.20 seconds
Standard Deviation 12.20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of interventionPopulation: All participants received all interventions as assigned during all 3 intervention periods and were assessed for gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=3 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=6 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
38.37 seconds
Standard Deviation 14.47
|
41.64 seconds
Standard Deviation 21.34
|
30.47 seconds
Standard Deviation 20.43
|
SECONDARY outcome
Timeframe: Day 2 of interventionPopulation: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total).
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=1 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=5 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
24.28 seconds
Standard Deviation 0
|
37.53 seconds
Standard Deviation 17.18
|
24.21 seconds
Standard Deviation 13.01
|
SECONDARY outcome
Timeframe: Day 3 of interventionPopulation: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one period of the the Ekso alone arm. Another participant was not assessed for gait speed for one period of the the anode tsDCS+Ekso arm. For the cathode tsDCS+Ekso arm, 1 received intervention once (1 data point). For the anode tsDCS+Ekso arm, 2 received intervention once (2 data points). For the Ekso alone arm, 1 received intervention once, and 2 received it twice (5 data points).
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=1 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=2 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=5 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
16.42 seconds
Standard Deviation 0
|
26.85 seconds
Standard Deviation 15.07
|
22.98 seconds
Standard Deviation 9.62
|
SECONDARY outcome
Timeframe: Day 4 of interventionPopulation: One participant was not assessed for gait speed for two intervention periods of the cathode tsDCS + Ekso arm and one intervention period of the the Ekso alone arm. For the cathode tsDCS + Ekso arm, 1 received the intervention once (1 data point total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 1 received the intervention once, and 2 received the intervention twice (5 data points total).
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=1 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
|
Ekso Alone
n=5 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
|
|---|---|---|---|
|
Gait Speed as Assessed by 10 Meter Walk Test
|
17.79 seconds
Standard Deviation 0
|
38.43 seconds
Standard Deviation 19.06
|
21.92 seconds
Standard Deviation 7.87
|
SECONDARY outcome
Timeframe: Day 5 of interventionPopulation: All participants received all interventions as assigned during all 3 intervention periods and were assessed for Gait speed. For the cathode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the anode tsDCS + Ekso arm, 1 received the intervention once, and 1 received the intervention twice (3 data points total). For the Ekso alone arm, 2 received the intervention once, and 2 received the intervention twice (6 data points total).
Subjects will undergo a walking session with Ekso, Ekso will then be removed, and subjects will then perform a 10 Meter Walk Test (10MWT) without use of Ekso exoskeleton. The 10MWT will assess subject's gait speed. Four marks will be placed on the ground at 0, 2, 12 and 14 meters. Subjects will walk a total of 14 meters. The middle 10 meters (between marks at 2 and 12 meters) will be timed and recorded as their gait speed.
Outcome measures
| Measure |
No Intervention
n=3 data points
Neither Ekso nor tsDCS are applied.
|
Anode tsDCS + Ekso
n=3 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
tsDCS applies electrical current to the spinal cord via surface electrodes placed on the skin.
Anode tsDCS plus Ekso involves anode tsDCS application followed by a walking session in Ekso.
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Ekso Alone
n=6 data points
Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
Ekso alone will consist of a walking session in Ekso with no tsDCS.
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Gait Speed as Assessed by 10 Meter Walk Test
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39.38 seconds
Standard Deviation 17.82
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35.35 seconds
Standard Deviation 18.51
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26.43 seconds
Standard Deviation 12.93
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Adverse Events
Cathode tsDCS + Ekso
Anode tsDCS + Ekso
Ekso Alone
No Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marcie Kern, PT, MSPT
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place