Spinal Cord InjuryNCT05921175
Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI
A study testing RGT+ tSCS + conventional physiotherap and RGT+ conventional physiotherapy in people with Spinal Cord Injury, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- RGT+ tSCS + conventional physiotherap and RGT+ conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSingapore
- Study dates
- 13 Nov 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ning Tang, PhD contact
Singapore1 site, 1 recruiting
- Recruiting
Alexandra Hospital
Singapore, Singapore, 159964
Gobinathan Chandran, MBBS, +65 94575924, Gobinathan_CHANDRAN@nuhs.edu.sg
About this study
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
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.
Read the 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 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. 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.
- Conditions
- Spinal Cord Injury
- Being tested
- RGT+ tSCS + conventional physiotherap, RGT+ conventional physiotherapy
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, robotic gait training
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGT+ tSCS + conventional physiotherapDevice
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 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.
RGT+ conventional physiotherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RGT+ conventional physiotherapy | Active comparator | 16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks Receives: Device: RGT+ conventional physiotherapy |
| RGT+ tSCS + conventional physiotherapy | Experimental | Phase 2: 16 sessions of RGT training + transcutaneous electrical stimulation (tSCS) + functional training in 8-10 weeks. Receives: Device: RGT+ tSCS + conventional physiotherap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Measured: Week 0
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Measured: Week 8
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Measured: Week 17
Walking Index in Spinal Cord Injury-II (WISCI-II)
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Measured: Week 0
Walking Index in Spinal Cord Injury-II (WISCI-II)
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Measured: Week 8
Walking Index in Spinal Cord Injury-II (WISCI-II)
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Measured: Week 17
10-Meter Walk Test (10MWT)
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Measured: Week 0
10-Meter Walk Test (10MWT)
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Measured: Week 8
10-Meter Walk Test (10MWT)
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Measured: Week 17
Central motor conduction time (CMCT)
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Measured: Week 0
Central motor conduction time (CMCT)
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Measured: Week 8
Central motor conduction time (CMCT)
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Measured: Week 17
International standards for Neurological Classification of SCI (ISNCSCI)
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
Measured: Week 0
International standards for Neurological Classification of SCI (ISNCSCI)
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
Measured: Week 8
International standards for Neurological Classification of SCI (ISNCSCI)
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
Measured: Week 17
Secondary outcomes (9)
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 0
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 8
EQ5D
EQ5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. It has one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each dimension scored from 1 to 5, the higher score indicates worse performance.
Measured: Week 17
Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change
Measured: Week 0
Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change
Measured: Week 8
Modified Tardieu Scale
Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement. It will be measured for Quadriceps, Hamstrings, Gastrocnemius. A large difference between R1 and R2 suggests a large dynamic component with a greater capacity for change or improvement. A small difference between R1 and R2 suggests a predominantly fixed contracture in the muscle with a poorer capacity for change
Measured: Week 17
EMG measurement
EMG signals from bilateral Quadriceps, Tibialis Anterior, Gastrocnemius, Rectus Abdominis will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.
Measured: Week 0
EMG measurement
EMG signals from bilateral Quadriceps, Tibialis Anterior, Gastrocnemius, Rectus Abdominis will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.
Measured: Week 8
EMG measurement
EMG signals from bilateral Quadriceps, Tibialis Anterior, Gastrocnemius, Rectus Abdominis will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.
Measured: Week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start13 Nov 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Gobinathan Chandran, MBBS, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05921175
- Sponsor's protocol ID
- 2023/00350 & 2024/4401
- Other IDs
- 2023
- Status last verified
- May 2025
- First submitted
- 19 Jun 2023
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05921175
- Acronym / sponsor ID
- 2023/00350 & 2024/4401
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, robotic gait training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury.
| Arm | Type | Receives |
|---|---|---|
| RGT+ conventional physiotherapy | Active comparator | Device: RGT+ conventional physiotherapy16 sessions of robotic gait training (RGT) + conventional physiotherapy in 8-10 weeks |
| RGT+ tSCS + conventional physiotherapy | Experimental | Device: RGT+ tSCS + conventional physiotherapPhase 2: 16 sessions of RGT training + transcutaneous electrical stimulation (tSCS) + functional training in 8-10 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RGT+ tSCS + conventional physiotherapSubject 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 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. | Device | RGT+ tSCS + conventional physiotherapy |
| RGT+ conventional physiotherapySubject 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. | Device | RGT+ conventional physiotherapy |
Primary outcome
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
Time frame: Week 0
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
Time frame: Week 8
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Spinal Cord Injury - Trunk Control Test (SCI-TCT)
Time frame: Week 17
It measures 4 simple aspect of trunk movement: 1) rolling to weak side; 2) rolling to strong side; 3) balance in sitting position; 4) sit up from lying down. The final score ranges from 0 (minimum) to 100 (maximum, indicating better performance)
Walking Index in Spinal Cord Injury-II (WISCI-II)
Time frame: Week 0
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Walking Index in Spinal Cord Injury-II (WISCI-II)
Time frame: Week 8
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
Walking Index in Spinal Cord Injury-II (WISCI-II)
Time frame: Week 17
It is an ordinal scale of 20 items assessing the amount of physical assistance needed, as well as device required, for walking following paralysis that results from spinal cord injury. Final score ranges from 0 (minimum) to 20 (maximum, indicating better performance).
10-Meter Walk Test (10MWT)
Time frame: Week 0
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
10-Meter Walk Test (10MWT)
Time frame: Week 8
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
10-Meter Walk Test (10MWT)
Time frame: Week 17
It measures walking speed when subject walks at comfortable speed, covered in the distance of 10 meters. Higher result indicates higher walking speed/better performance.
Central motor conduction time (CMCT)
Time frame: Week 0
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Central motor conduction time (CMCT)
Time frame: Week 8
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
Central motor conduction time (CMCT)
Time frame: Week 17
Measured by transcranial magnetic stimulation (TMS). It is calculated by subtracting the peripheral conduction time (PMCT) from motor evoked potential (MEP) latency elicited by TMS to the motor cortex. Higher results indicates longer central motor conduction time and poor performance.
International standards for Neurological Classification of SCI (ISNCSCI)
Time frame: Week 0
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
International standards for Neurological Classification of SCI (ISNCSCI)
Time frame: Week 8
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
International standards for Neurological Classification of SCI (ISNCSCI)
Time frame: Week 17
The test is to define and describe the extent and severity of a patient's spinal cord injury. The patient's grade is based on how much sensation he or she can feel at multiple points on the body, as well as tests of motor function. The results ranged from A (worst- complete lack of motor and sensory function below the level of injury) to E (best, all neurologic function has returned)
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ning Tang, PhD contact
Gobinathan Chandran, MBBS principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RGT+ tSCS + conventional physiotherap and RGT+ conventional physiotherapy in people with Spinal Cord Injury, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gobinathan Chandran, MBBS ((65) 94575924, Gobinathan_CHANDRAN@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal Cord Injury - Trunk Control Test (SCI-TCT) (time frame: Week 0). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.