Recruiting NCT05921175

Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

No phase Interventional Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: RGT+ tSCS + conventional physiotherap, RGT+ conventional physiotherapy.
Who it may be relevant to: Registry conditions: Spinal Cord Injury. Basic parameters: 21 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Singapore
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Detailed description

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. Once subject is identified to be eligible for the study and is agreeable to participate into the study, he/she 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 lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment. During tSCS, two surface electrodes will be positioned in between the vertebral processes located generally one vertebral segment rostral and one vertebral segment caudal to the site of injury. Reference/Ground 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 patient's 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.

Interventions

Device RGT+ tSCS + conventional physiotherap
Subject will undergo 16 sessions of robotic gait training (RGT) + tSCS+ conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower 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. Reference/Ground electrodes placed over the ASIS It will be on bipha
Device RGT+ conventional physiotherapy
Subject will undergo 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks. Subject will walk with EksoGT for gait training during RGT training. Components of conventional physiotherapy will include upper/lower limb ergometry and strength training as prescribed by the attending physiotherapist based on their assessment.

Primary outcome measures

Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Time frame: Week 0]
Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Time frame: Week 8]
Spinal Cord Injury - Trunk Control Test (SCI-TCT) [Time frame: Week 17]
Walking Index in Spinal Cord Injury-II (WISCI-II) [Time frame: Week 0]
Walking Index in Spinal Cord Injury-II (WISCI-II) [Time frame: Week 8]
Walking Index in Spinal Cord Injury-II (WISCI-II) [Time frame: Week 17]
10-Meter Walk Test (10MWT) [Time frame: Week 0]
10-Meter Walk Test (10MWT) [Time frame: Week 8]
10-Meter Walk Test (10MWT) [Time frame: Week 17]
Central motor conduction time (CMCT) [Time frame: Week 0]

Secondary outcome measures (9)

EQ5D [Time frame: Week 0]
EQ5D [Time frame: Week 8]
EQ5D [Time frame: Week 17]
Modified Tardieu Scale [Time frame: Week 0]
Modified Tardieu Scale [Time frame: Week 8]
Modified Tardieu Scale [Time frame: Week 17]
EMG measurement [Time frame: Week 0]
EMG measurement [Time frame: Week 8]
EMG measurement [Time frame: Week 17]

Eligibility criteria

Inclusion criteria

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.

Exclusion criteria

Participant has uncontrolled cardiopulmonary disease or cardiac symptoms as determined by the investigator;
Participant has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound performance and outcomes like uncontrolled neuropathic pain, depression, severe cognitive impairment;
Unstable or uncontrolled autonomic dysreflexia;
Requires ventilator support;
Spasms that limit the ability of the subjects to participate in the study training as determined by the investigator;
Skin conditions that limit the application of tSCS electrodes;
Active implanted medical devices that may be affected by tSCS;
Pregnant, planning to become pregnant or breastfeeding;
Concurrent participation in another drug or device trial that may interfere with this study;
Participated in wearable exoskeleton training within the last 3 months prior to enrolment.
Peripheral nerve injury or significant Lumbar Radiculopathy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Crossover
Masking: Open label
Primary purpose: Treatment

Study locations

Singapore · 1 center

Alexandra Hospital — Singapore

Identifiers

NCT: NCT05921175 · 2023/00350 & 2024/4401

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗