Trial Outcomes & Findings for Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury (NCT NCT01962675)
NCT ID: NCT01962675
Last Updated: 2015-11-16
Results Overview
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
TERMINATED
NA
15 participants
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
2015-11-16
Participant Flow
One participant withdrew before assignment
Participant milestones
| Measure |
Real tDCS - Sham tDCS
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles
Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
|
Sham tDCS - Real tDCS
Sham tDCS+skilled training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Step training: Stepping over specified soft foam obstacles
Real tDCS+skilled training
Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity
Step training: Stepping over specified soft foam obstacles
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Change from baseline score of the time required to perform 10 m walking.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.Population: Study was to be PhD student dissertation. PI left institution. Months later PhD student withdrew without notice. Data were stored on computers and not accessible to PI. Computers were replaced by new lab director.
Measuring the Time required to perform toe taps
Outcome measures
Outcome data not reported
Adverse Events
tDCS and Skilled Training
Sham tDCS and Skilled Leg Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place