Viewing Study NCT05921175



Ignite Creation Date: 2024-05-06 @ 7:11 PM
Last Modification Date: 2024-10-26 @ 3:02 PM
Study NCT ID: NCT05921175
Status: NOT_YET_RECRUITING
Last Update Posted: 2023-09-08
First Post: 2023-06-19

Brief Title: tSCS EksoGT in SCI Patients
Sponsor: National University Hospital Singapore
Organization: National University Hospital Singapore

Study Overview

Official Title: 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: NOT_YET_RECRUITING
Status Verified Date: 2024-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 tSCSRGT 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
Detailed Description: 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 tSCSRGT 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 Once subject is identified to be eligible for the study and is agreeable to participate into the study heshe will undergo Phase 1 of training which consists of 16 sessions of robotic gait training RGT conventional physiotherapy in 8-10 weeks After a 1-week washout period subject will undergo Phase 2 of training which consists of 16 sessions of RGT training tSCS conventional physiotherapy in 8-10 weeks

Subject will walk with EksoGT for gait training during RGT training Components of conventional physiotherapy will include upperlower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment During tSCS cathodes will be placed on the T11 and L1 spinous process ReferenceGround electrodes placed over the ASIS It will be on biphasic mode with an overlap frequency of 10kHz Burst Frequency of 30Hz Pulse width of 1ms Stimulation intensity ranges from 5-100 mA and will be adjusted according to the patients response The tSCS stimulation duration for each session will be 45 minutes in conjunction with the RGT training

Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline within 1 week before the starting of Phase 1 of training Post-Phase 1 within 1 week after Phase 1 of training and Post-Phase 2 within 1 week after Phase 2 of training

A satisfaction survey on the intervention RGT training tSCS conventional physiotherapy will be performed at week-18 assessment

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None