Paraplegia Clinical Trials

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A Pilot Study on the Cumulative Effects of Transcutaneous Spinal Cord Stimulation (tSCS) With Robotic Gait Training in Trunk Muscle Activity and Walking Index in Chronic Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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 spinal cord injuries. 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 injury. 6 subjects with paraplegia and 6 subjects with tetraplegia 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 65
Healthy Volunteers: f
View:

• Between 6 months to 5 years from the diagnosis of the traumatic SCI and who are not walking independently;

• Age between 21 to 65 years old;

• Incomplete spinal cord injury: ASIA Impairment Scale (AIS) Grade: B-D;

• Spinal cord injury level: T1- L1, or C2-C8;

• SCI-TCT Score \> 13;

• Capable of providing an informed consent;

• Cleared by Neurosurgeons/ Orthopeadic Surgeons for tSCS;

• Meets prerequisites for Ekso wearable robotic exoskeleton training.

Locations
Other Locations
Singapore
Alexandra Hospital
RECRUITING
Singapore
Contact Information
Primary
Gobinathan Chandran, MBBS
Gobinathan_CHANDRAN@nuhs.edu.sg
(65) 94575924
Backup
Ning Tang, PhD
ning_tang@nuhs.edu.sg
Time Frame
Start Date: 2024-11-13
Estimated Completion Date: 2026-09
Participants
Target number of participants: 6
Treatments
Active_comparator: RGT+ conventional physiotherapy
16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks
Experimental: RGT+ tSCS + conventional physiotherapy
Phase 2: 16 sessions of RGT training + transcutaneous electrical stimulation (tSCS) + functional training in 8-10 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Alexandra Hospital
Leads: National University Hospital, Singapore

This content was sourced from clinicaltrials.gov