tSCS + EksoGT in SCI Patients - Trial NCT05921175
Access comprehensive clinical trial information for NCT05921175 through Pure Global AI's free database. This phase not specified trial is sponsored by National University Hospital, Singapore and is currently Not yet recruiting. The study focuses on Spinal Cord Injury. Target enrollment is 6 participants.
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Study Focus
Sponsor & Location
National University Hospital, Singapore
Timeline & Enrollment
N/A
Aug 01, 2023
Sep 01, 2023
Primary Outcome
Spinal Cord Injury - Trunk Control Test (SCI-TCT),Spinal Cord Injury - Trunk Control Test (SCI-TCT),Spinal Cord Injury - Trunk Control Test (SCI-TCT),Walking Index in Spinal Cord Injury-II (WISCI-II),Walking Index in Spinal Cord Injury-II (WISCI-II),Walking Index in Spinal Cord Injury-II (WISCI-II),10-Meter Walk Test (10MWT),10-Meter Walk Test (10MWT),10-Meter Walk Test (10MWT),Central motor conduction time (CMCT),Central motor conduction time (CMCT),Central motor conduction time (CMCT),International standards for Neurological Classification of SCI (ISNCSCI),International standards for Neurological Classification of SCI (ISNCSCI),International standards for Neurological Classification of SCI (ISNCSCI)
Summary
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can
 augment robotic gait training (RGT) to improve functional mobility in participants with
 chronic paraplegia. It also evaluate the impact of the tSCS+RGT on health-related quality of
 life (HRQOL), compared to RGT alone.
 
 This is a prospective single-arm crossover study in participants with incomplete chronic
 traumatic spinal cord paraplegia. 6 subjects will be recruited. The intervention includes
 Phase 1 of training which consists of 16 sessions of robotic gait training (RGT) +
 conventional physiotherapy in 8-10 weeks, and Phase 2 of training which consists of 16
 sessions of RGT training + tSCS + conventional physiotherapy in 8-10 weeks.
 
 Outcome measures including mobility function assessment and neuromuscular assessment will be
 collected at Baseline, Post-Phase 1 and Post-Phase 2. A satisfaction survey on the
 intervention RGT training + tSCS + conventional physiotherapy will be performed at week-18
 assessment.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05921175
Device Trial