Spinal Cord InjuriesNCT07432321
tSCS + UL Robotics Training in SCI Patients
A study testing ULRT + tSCS + conventional occupational therapy and ULRT + conventional occupational therapy in people with Spinal Cord Injuries, 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 upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- ULRT + tSCS + conventional occupational therapy and ULRT + conventional occupational therapy
- 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
- 18 Sep 2025to 30 Sep 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 6 months to 5 years from the diagnosis of the traumatic SCI;
- Participants between 21 and 80 years of age;
- C2-8 level injuries;
- ISNCSCI-UEMS >25,
- Pinch force > 25 N;
- Grasp force > 100 N;
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- Able to perform the box and block test;
- Sitting tolerance for at least 1 hour (No known postural hypotension issues or pressure intolerance);
- Capable of providing an informed consent;
- Cleared by Neurosurgeons/Orthopaedic Surgeon for tSCS;
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.
- Has an autoimmune etiology of spinal cord dysfunction/injury
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- History of additional neurologic disease, such as stroke, multiple sclerosis and traumatic brain Injury.
- Pain in shoulder and/or hand which will be inhibitory towards rehabilitative therapy.
- Severe Upper limb contractures.
- Acute Medical conditions to Upper limb (ie Fractures that would limit ROM and/or weightbearing).
- Participants who are pregnant.
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 Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic Spinal Cord Injury
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.
Read the detailed description
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with C2-8 level injuries 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 upper limb robotic training (ULRT) + conventional occupational therapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
This study will use the locally developed H-Man arm rehabilitation robot and Esoglove™ PRO hand rehabilitation system for ULRT. The H-Man robot, a table-top, portable, 2D planar, end-effector with virtual reality feedback is designed to deliver self-paced, repetitive reaching arm movements. The soft robotic glove EsoGlove enables patients to carry out upper-limb rehabilitation with multiple training modes, such as passive training, active-assisted range of motion training, and bilateral training. Participants could choose either H-man or Esoglove, or use both alternatively for ULRT training, according to their functional impairment. ULRT will be paired with functional training during the intervention sessions.
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), Post-Phase 2 (within 1 week after Phase 2 of training), and 4 weeks Post Phase 2
A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
- Conditions
- Spinal Cord Injuries
- Being tested
- ULRT + tSCS + conventional occupational therapy, ULRT + conventional occupational therapy
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, upper limb robotic training (ULRT)
- 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.
ULRT + tSCS + conventional occupational therapyDevice
Subject will undergo 16 sessions of Upper limb robotics training (ULRT) + tSCS+ conventional occupational therapy, 2 sessions a week for 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist 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 a stimulation delivered at 30-50 Hz with a 10-kHz carrier frequency overlay, which consisted of 10 pulses with a 10-kHz frequency and 100-µs pulse width.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 ULRT training.
ULRT + conventional occupational therapyDevice
Participants will undergo 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment.
| Study group | Role | What they receive |
|---|---|---|
| ULRT+ conventional occupational therapy | Active comparator | 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks Receives: Device: ULRT + conventional occupational therapy |
| ULRT + tSCS + conventional occupational therapy | Experimental | Phase 2: 16 sessions of ULRT training + transcutaneous electrical stimulation (tSCS) + conventional occupational therapy in 8-10 weeks Receives: Device: ULRT + tSCS + conventional occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Measured: Week 0
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Measured: Week 8
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Measured: Week 16
GRASSP 2
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
Measured: Week 20
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 16
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 20
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 16
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 20
Capabilities of Upper Extremity Test (CUE-T)
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Measured: Week 0
Capabilities of Upper Extremity Test (CUE-T)
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Measured: Week 8
Capabilities of Upper Extremity Test (CUE-T)
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Measured: Week 16
Capabilities of Upper Extremity Test (CUE-T)
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Measured: Week 20
Secondary outcomes (32)
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Measured: Week 0
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Measured: Week 8
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Measured: Week 16
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
To assess grip and pinch strength, a dynamometer is used for overall grip and a pinch gauge measures different pinch type. Testing involves subject sitting with arm bent at the elbow to 90 degrees and forearm in neutral position. The subject will squeeze the dynamometer and pinch the gauge as hard as possible in a smooth motion. Three trials will be performed, and the average of these recordings is recorded.
Measured: Weeks 20
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 16
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 20
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 16
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 20
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 Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors 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 Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.
Measured: Week 16
EMG measurement
EMG signals from bilateral Biceps, Triceps, Wrist Extensors/Flexors and Finger Extensors/Flexors will be recorded for about 10 seconds. Root-Mean-Square (RMS) of the EMG signals will be calculated.
Measured: Week 20
Box and Block Assessment
It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.
Measured: Week 0
Box and Block Assessment
It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.
Measured: Week 8
Box and Block Assessment
It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.
Measured: Week 16
Box and Block Assessment
It assesses gross motor dexterity by measuring the number of small blocks the subject can move from one compartment of a box to another within 60 seconds.
Measured: Week 20
Nine Hole Peg Test
It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.
Measured: Week 0
Nine Hole Peg Test
It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.
Measured: Week 8
Nine Hole Peg Test
It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.
Measured: Week 16
Nine Hole Peg Test
It is a standardized, quantitative assessment used to measure finger dexterity. It is administered by asking the subject to take the pegs from a container, one by one, and place them into holes on the board as quickly as possible. The subject must then remove the pegs from the holes, one by one, and replace them back into the container.
Measured: Week 20
Spinal Cord Injury Independence Measure (SCIIM)
It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).
Measured: Week 0
Spinal Cord Injury Independence Measure (SCIIM)
It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).
Measured: Week 8
Spinal Cord Injury Independence Measure (SCIIM)
It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).
Measured: Week 16
Spinal Cord Injury Independence Measure (SCIIM)
It is for assessing ADL function. It looks at self-care, respiration and sphincter management, and a patient's mobility abilities. Scores range from 0 (total dependence) to 100 (complete independence).
Measured: Week 20
Modified Goal attainment Scale (GAS)
It provides a measure of how much of patient identified goals are achieved at the time of assessment.
Measured: Week 0
Modified Goal attainment Scale (GAS)
It provides a measure of how much of patient identified goals are achieved at the time of assessment.
Measured: Week 8
Modified Goal attainment Scale (GAS)
It provides a measure of how much of patient identified goals are achieved at the time of assessment.
Measured: Week 16
Modified Goal attainment Scale (GAS)
It provides a measure of how much of patient identified goals are achieved at the time of assessment.
Measured: Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start18 Sep 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- 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
- NCT07432321
- Sponsor's protocol ID
- 2025/0420
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- 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 25 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 Upper Limb Robotics Training in Upper Limb Rehabilitation in Patients With Tetraplegic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07432321
- Acronym / sponsor ID
- 2025/0420
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, upper limb robotic training (ULRT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Alexandra Hospital
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Feb 2026 (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 upper limb robotic training (ULRT) to improve functional mobility in participants with chronic spinal cord injuries. It also evaluates the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 to 8 subjects with C2-8 level injuries will be recruited. The intervention includes Phase 1 of training which consists of 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks, and Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
Outcome measures including mobility function assessment and neuromuscular assessment will be collected at Baseline, Post-Phase 1, Post-Phase 2, and 4 weeks Follow-up. A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at end of the study.
Detailed description
This study is aimed to evaluate whether transcutaneous spinal cord stimulation (tSCS) can augment upper limb robotic training (ULRT) to improve functional mobility in participants with chronic paraplegia. It also evaluate the impact of the tSCS+ULRT on health-related quality of life (HRQOL), compared to ULRT alone.
This is a prospective single-arm crossover study in participants with incomplete chronic traumatic spinal cord injury. 6 subjects with C2-8 level injuries 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 upper limb robotic training (ULRT) + conventional occupational therapy in 8-10 weeks. After a 1-week washout period, subject will undergo Phase 2 of training which consists of 16 sessions of ULRT training + tSCS + conventional occupational therapy in 8-10 weeks.
This study will use the locally developed H-Man arm rehabilitation robot and Esoglove™ PRO hand rehabilitation system for ULRT. The H-Man robot, a table-top, portable, 2D planar, end-effector with virtual reality feedback is designed to deliver self-paced, repetitive reaching arm movements. The soft robotic glove EsoGlove enables patients to carry out upper-limb rehabilitation with multiple training modes, such as passive training, active-assisted range of motion training, and bilateral training. Participants could choose either H-man or Esoglove, or use both alternatively for ULRT training, according to their functional impairment. ULRT will be paired with functional training during the intervention sessions.
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), Post-Phase 2 (within 1 week after Phase 2 of training), and 4 weeks Post Phase 2
A satisfaction survey on the intervention "ULRT training + tSCS + conventional physiotherapy" will be performed at week-18 assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- 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 |
|---|---|---|
| ULRT+ conventional occupational therapy | Active comparator | Device: ULRT + conventional occupational therapy16 sessions of ULRT + conventional occupational therapy in 8-10 weeks |
| ULRT + tSCS + conventional occupational therapy | Experimental | Device: ULRT + tSCS + conventional occupational therapyPhase 2: 16 sessions of ULRT training + transcutaneous electrical stimulation (tSCS) + conventional occupational therapy in 8-10 weeks |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 6 months to 5 years from the diagnosis of the traumatic SCI;
- Participants between 21 and 80 years of age;
- C2-8 level injuries;
- ISNCSCI-UEMS >25,
- Pinch force > 25 N;
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 |
|---|---|---|
| ULRT + tSCS + conventional occupational therapySubject will undergo 16 sessions of Upper limb robotics training (ULRT) + tSCS+ conventional occupational therapy, 2 sessions a week for 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist 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 a stimulation delivered at 30-50 Hz with a 10-kHz carrier frequency overlay, which consisted of 10 pulses with a 10-kHz frequency and 100-µs pulse width.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 ULRT training. | Device | ULRT + tSCS + conventional occupational therapy |
| ULRT + conventional occupational therapyParticipants will undergo 16 sessions of ULRT + conventional occupational therapy in 8-10 weeks. Participants will use either H-Man arm rehabilitation robot or Esoglove™ PRO hand rehabilitation system, or both according to their functional impairment for ULRT. Participants will undergo conventional occupational therapy as prescribed by the attending occupational therapist based on their assessment. | Device | ULRT+ conventional occupational therapy |
Primary outcome
GRASSP 2
Time frame: Week 0
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
Time frame: Week 8
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
Time frame: Week 16
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
GRASSP 2
Time frame: Week 20
The GRASSP Version 2 is a clinical impairment measure specific to the upper limb for use after tetraplegia. The GRASSP measure sensorimotor and prehension function through three domains; important in describing arm and hand function.
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 16
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 20
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)
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 16
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 20
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.
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Week 0
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Week 8
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Week 16
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
Capabilities of Upper Extremity Test (CUE-T)
Time frame: Week 20
It is used for assessing functional limitations, assessing upper extremity functions of the subject. A higher score suggests greater upper extremity function.
32 secondary outcomes
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
Time frame: Week 0
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
Time frame: Week 8
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
Time frame: Week 16
Grip, Pinch and Tripod Pinch Strength, measured using Dynamometer and Pinch Gauge
Time frame: Weeks 20
Modified Tardieu Scale
Time frame: Week 0
Modified Tardieu Scale
Time frame: Week 8
Modified Tardieu Scale
Time frame: Week 16
Modified Tardieu Scale
Time frame: Week 20
EQ5D
Time frame: Week 0
EQ5D
Time frame: Week 8
EQ5D
Time frame: Week 16
EQ5D
Time frame: Week 20
EMG measurement
Time frame: Week 0
EMG measurement
Time frame: Week 8
EMG measurement
Time frame: Week 16
EMG measurement
Time frame: Week 20
Box and Block Assessment
Time frame: Week 0
Box and Block Assessment
Time frame: Week 8
Box and Block Assessment
Time frame: Week 16
Box and Block Assessment
Time frame: Week 20
Nine Hole Peg Test
Time frame: Week 0
Nine Hole Peg Test
Time frame: Week 8
Nine Hole Peg Test
Time frame: Week 16
Nine Hole Peg Test
Time frame: Week 20
Spinal Cord Injury Independence Measure (SCIIM)
Time frame: Week 0
Spinal Cord Injury Independence Measure (SCIIM)
Time frame: Week 8
Spinal Cord Injury Independence Measure (SCIIM)
Time frame: Week 16
Spinal Cord Injury Independence Measure (SCIIM)
Time frame: Week 20
Modified Goal attainment Scale (GAS)
Time frame: Week 0
Modified Goal attainment Scale (GAS)
Time frame: Week 8
Modified Goal attainment Scale (GAS)
Time frame: Week 16
Modified Goal attainment Scale (GAS)
Time frame: Week 20
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 25 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 ULRT + tSCS + conventional occupational therapy and ULRT + conventional occupational therapy in people with Spinal Cord Injuries, 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 10 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 25 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?
GRASSP 2 (time frame: Week 0). The study lists 16 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 25 Feb 2026.