Spinal Cord InjuryNCT07037628
Investigating the Impact of Spinal Cord Electrical Stimulation Combined With Individualized Physical Therapy on Lower Extremity Function in Patients With Spinal Cord Injury
An observational study of Spinal Cord Injury and Spinal Cord Injury Thoracic, run by Lian-Cing Yan, MSPT at 1 site in Taiwan.
Trial summary
This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries: 1. Spinal cord stimulation (SCS) combined with one-on-one physical therapy 2. One-on-one physical therapy alone Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury/Damage
- How many people
- 76 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 31 Dec 2028
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon for spinal cord stimulation (SCS) and/or individualized physical therapy.
Who may be able to join
- Aged between 20 and 70 years.
- Diagnosed with spinal cord injury, classified as ASIA Grade A-D.
- Neurological level of injury between T1 and L2.
- Spinal cord injury has stabilized (for at least 3 months).
- Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon to receive spinal cord stimulation (SCS) and/or individualized physical therapy.
- Capable of participating in one-on-one physical therapy sessions 3 to 5 times per week, and assessed by the medical team as able to complete at least a 3 weeks course of treatment.
- Fully conscious, able to understand the study information, and willing to sign the consent form and participate in the full assessment process.
Who cannot join
- Individuals with severe brain injury, neurodegenerative diseases, or other major neurological disorders.
- Those with severe fractures, joint contractures, or conditions preventing participation in lower limb training.
- Individuals with a cardiac pacemaker or who are pregnant.
- Those unable to comply with the treatment or assessment procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City
LIAN-CING YAN, +88638561825 ext. 13054
About this study
This study aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries:
- Spinal cord stimulation (SCS) combined with one-on-one physical therapy
- One-on-one physical therapy alone
Read the detailed description
This study adopts a prospective controlled design to observe and explore the effect of SCS combined with one-on-one physical therapy on the recovery of lower limb function in patients with spinal cord injury. The aims is to collect clinical practice data and provide reference for future related treatment strategies and care, hoping to increase the treatment options for rehabilitation of patients with spinal cord injury and improve their functional performance and quality of life.
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury/Damage, Spinal Cord Injury T1-L2, Spinal Cord Stimulation (SCS), Spinal Cord Stimulation
- Keywords
- ASIA B, ASIA C, ASIA D, ASIA A
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Spinal cord stimulation (SCS) combined with one-on-one physical therapy | |
| Control group | One-on-one physical therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Spinal Injury Association (ASIA) Impairment Scale
-AIS A (Complete): S4-S5 have no sensory and motor function.
-AIS B (Sensory Incomplete): S4-S5 have sensory function (light touch or pinprick sensation or deep anal pressure sensation), but no motor function.
And the motor function score of more than three levels below the injury plane is 0.
-AIS C (Motor Incomplete): S4-S5 have motor function (voluntary anal sphincter contraction), or the sacral ganglion has sensory function and more than half of the key muscle groups below the injury plane have a strength of less than 3 points.
-AIS D (Motor Incomplete): The muscle strength of at least half of the key muscle groups below the injury plane is greater than or equal to 3 points.
-AIS E (Normal): Both sensory and motor functions are tested normal.
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Modified Ashworth Scale (MAS)
Grade judgment:
- 0 points: No increase in muscle tension.
- 1 point: Slight increase in muscle tension at the end of the joint range of motion, manifested as a sudden jam and immediate relaxation.
- 1+ points: Slight increase in muscle tension in less than half of the joint range of motion, followed by minimal resistance in the remaining range of motion.
- 2 points: Significant increase in muscle tension in most of the joint range of motion, but the joint can still be moved easily.
- 3 points: Significant increase in muscle tension, passive movement becomes difficult.
- 4 points: The joint becomes stiff in flexion or extension and cannot be moved passively.
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Handheld Dynamometer
Force application method: The assessor instructs the patient to resist with all his strength, and the assessor gradually applies force until the patient is unable to resist and collapses, and the maximum force value is recorded.
Data recording: 3 measurements are performed and the average value is taken. The unit of force is pounds (lbs).
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Spinal Cord Independence Measure (SCIM III)
Grade determination (scoring): Total score 0-100 points.
- Scoring principle: The higher the score, the better the patient's independence. The scoring criteria for each item are different.
The core concept is to give points based on the degree of assistance required by the patient when actually performing the task.
- High score: Completely independent, or only requires a small amount of assistive devices.
- Medium score: Partial assistance is required (for example: verbal prompts, others preparing items, a small amount of physical assistance).
- Low score: A lot of assistance is required or completely dependent on others.
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
World Health Organization Quality-of-Life Scale
Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence.
- Grade 0: The patient cannot stand or walk.
- Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed.
- Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers.
- Grade 9-12: No assistance from others, but requires a walker and may use different types of braces.
- Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces.
- Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace.
- Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Walking Index for Spinal Cord Injury (WISCI II)
Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence.
- Grade 0: The patient cannot stand or walk.
- Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed.
- Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers.
- Grade 9-12: No assistance from others, but requires a walker and may use different types of braces.
- Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces.
- Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace.
- Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.
Measured: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lian-Cing Yan, MSPT
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lian-Cing Yan, MSPT, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037628
- Sponsor's protocol ID
- IRB114-106-B
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 Jun 2025
- 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 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Impact of Spinal Cord Electrical Stimulation Combined With Individualized Physical Therapy on Lower Extremity Function in Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07037628
- Acronym / sponsor ID
- IRB114-106-B
- Conditions
- Spinal Cord Injury, Spinal Cord Injury Thoracic, Spinal Cord Injury/Damage, Spinal Cord Injury T1-L2, Spinal Cord Stimulation (SCS), Spinal Cord Stimulation
- Keywords
- ASIA B, ASIA C, ASIA D, ASIA A
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Lian-Cing Yan, MSPTUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 25 Jun 2025 (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 aims to understand the differences in the effects of two rehabilitation approaches on lower limb function recovery in patients with spinal cord injuries:
- Spinal cord stimulation (SCS) combined with one-on-one physical therapy
- One-on-one physical therapy alone
Detailed description
This study adopts a prospective controlled design to observe and explore the effect of SCS combined with one-on-one physical therapy on the recovery of lower limb function in patients with spinal cord injury. The aims is to collect clinical practice data and provide reference for future related treatment strategies and care, hoping to increase the treatment options for rehabilitation of patients with spinal cord injury and improve their functional performance and quality of life.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | –Spinal cord stimulation (SCS) combined with one-on-one physical therapy |
| Control group | – | –One-on-one physical therapy only |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon for spinal cord stimulation (SCS) and/or individualized physical therapy.
Key inclusion criteria (7 listed)
- Aged between 20 and 70 years.
- Diagnosed with spinal cord injury, classified as ASIA Grade A-D.
- Neurological level of injury between T1 and L2.
- Spinal cord injury has stabilized (for at least 3 months).
- Currently receiving standard treatment at Hualien Tzu Chi Hospital and referred by a neurosurgeon or orthopedic surgeon to receive spinal cord stimulation (SCS) and/or individualized physical therapy.
Key exclusion criteria (4 listed)
- Individuals with severe brain injury, neurodegenerative diseases, or other major neurological disorders.
- Those with severe fractures, joint contractures, or conditions preventing participation in lower limb training.
- Individuals with a cardiac pacemaker or who are pregnant.
- Those unable to comply with the treatment or assessment procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
American Spinal Injury Association (ASIA) Impairment Scale
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
-AIS A (Complete): S4-S5 have no sensory and motor function. -AIS B (Sensory Incomplete): S4-S5 have sensory function (light touch or pinprick sensation or deep anal pressure sensation), but no motor function. And the motor function score of more than three levels below the injury plane is 0. -AIS C (Motor Incomplete): S4-S5 have motor function (voluntary anal sphincter contraction), or the sacral ganglion has sensory function and more than half of the key muscle groups below the injury plane have a strength of less than 3 points. -AIS D (Motor Incomplete): The muscle strength of at least half of the key muscle groups below the injury plane is greater than or equal to 3 points. -AIS E (Normal): Both sensory and motor functions are tested normal.
Modified Ashworth Scale (MAS)
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Grade judgment: * 0 points: No increase in muscle tension. * 1 point: Slight increase in muscle tension at the end of the joint range of motion, manifested as a sudden jam and immediate relaxation. * 1+ points: Slight increase in muscle tension in less than half of the joint range of motion, followed by minimal resistance in the remaining range of motion. * 2 points: Significant increase in muscle tension in most of the joint range of motion, but the joint can still be moved easily. * 3 points: Significant increase in muscle tension, passive movement becomes difficult. * 4 points: The joint becomes stiff in flexion or extension and cannot be moved passively.
Handheld Dynamometer
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Force application method: The assessor instructs the patient to resist with all his strength, and the assessor gradually applies force until the patient is unable to resist and collapses, and the maximum force value is recorded. Data recording: 3 measurements are performed and the average value is taken. The unit of force is pounds (lbs).
Spinal Cord Independence Measure (SCIM III)
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Grade determination (scoring): Total score 0-100 points. - Scoring principle: The higher the score, the better the patient's independence. The scoring criteria for each item are different. The core concept is to give points based on the degree of assistance required by the patient when actually performing the task. * High score: Completely independent, or only requires a small amount of assistive devices. * Medium score: Partial assistance is required (for example: verbal prompts, others preparing items, a small amount of physical assistance). * Low score: A lot of assistance is required or completely dependent on others.
World Health Organization Quality-of-Life Scale
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence. * Grade 0: The patient cannot stand or walk. * Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed. * Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers. * Grade 9-12: No assistance from others, but requires a walker and may use different types of braces. * Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces. * Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace. * Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.
Walking Index for Spinal Cord Injury (WISCI II)
Time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.
Grade determination (0-20): A hierarchical scale from 0 to 20, with higher numbers representing better walking function and lower dependence. * Grade 0: The patient cannot stand or walk. * Grade 1-5: Requires physical assistance from 2 therapists and may use different types of braces. The higher the grade, the fewer braces are needed. * Grade 6-8: Requires physical assistance from 1 therapist and may use different types of braces or walkers. * Grade 9-12: No assistance from others, but requires a walker and may use different types of braces. * Grade 13-16: No assistance from others, but requires the use of two crutches and may use different types of braces. * Grade 17-19: No assistance from others, but requires the use of a single crutch or cane and may use a brace. * Grade 20: Walk 10 meters on flat ground without any physical assistance, braces or assistive devices.
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 27 Jun 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Spinal Cord Injury Thoracic, run by Lian-Cing Yan, MSPT at 1 site in Taiwan.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Jun 2025. 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 Taiwan. 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 LIAN-CING YAN (+88638561825 ext. 13054, cingcingyan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Spinal Injury Association (ASIA) Impairment Scale (time frame: Experimental group:To measure assessing change between pre-implant and one month after implant. Control group:To measure assessing change between Day 1 and one month after physical therapy.). The study lists 6 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 27 Jun 2025.