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NCT Number: NCT05921175

Transcutaneous Spinal Cord Stimulation With Robotic Gait Training in Chronic SCI

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RGT+ tSCS + conventional physiotherap

Device

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 physiotherapy

Device

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 outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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).

  5. 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).

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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)

  14. 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)

  15. 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)

Secondary outcomes

  1. EQ5D

    Time frame: Week 0

    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.

  2. EQ5D

    Time frame: Week 8

    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.

  3. EQ5D

    Time frame: Week 17

    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.

  4. Modified Tardieu Scale

    Time frame: Week 0

    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

  5. Modified Tardieu Scale

    Time frame: Week 8

    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

  6. Modified Tardieu Scale

    Time frame: Week 17

    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

  7. EMG measurement

    Time frame: Week 0

    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.

  8. EMG measurement

    Time frame: Week 8

    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.

  9. EMG measurement

    Time frame: Week 17

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gobinathan Chandran, MBBS

CONTACT

[email protected]

(65) 94575924

Ning Tang, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • Alexandra Hospital

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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