SCI - Spinal Cord InjuryNCT06650202
Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
A study testing The Tethered Pelvic Assist Device (TPAD) in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- The Tethered Pelvic Assist Device (TPAD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Jan 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Stable medical condition.
- Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time
- Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
- Unable to stand independently with epidural stimulation turned off.
Who cannot join
- unwilling to discontinue from anti-spasticity medications
- Untreated painful problems with joints, muscles or bones.
- Unhealed fracture.
- Pressure sore or urinary tract infection.
- History of bone disease (except for decreased bone mineral density due to spinal cord injury).
- Ongoing drug abuse.
Show all 10Show fewer
- Untreated psychiatric disorders or clinical depression.
- Received Botox injections in the lower extremities in the prior six months.
- Heart or lung disease that may interfere with assessments.
- Untreated severe and persistent problems regulating blood pressure, heart rate, body temperature or other automatic functions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Research Manager, 9733243557, LMartinez@KesslerFoundation.Org
About this study
The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. The investigators will be testing a device called the Tethered Pelvic Asist Device (or "TPAD") in this study. The TPAD may be helpful in two ways. It can be used to help control and support of the trunk, pelvis, and knees during stand training. Also, the TPAD can be used as a training tool by providing controlled "pushes" or "perturbations" that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury.
Participants will be placed into one of two groups based on availability and preference. Group 1 will receive TPAD training with stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.
Read the detailed description
The aims of the proposed study are to (a) examine the muscle activation patterns generated during stable and perturbed standing in spinal cord injured individuals using spinal cord epidural stimulation (scES) and robotic TPAD-assistance or self-assistance for balance, and (b and c) to examine the effectiveness of TPAD-assisted stand training in the improvement of postural control during stable and perturbed standing and sitting in spinal cord injured individuals using spinal cord epidural stimulation (scES).
The Tethered Pelvic Assist Device (TPAD) is a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
A total of 20 spinal cord injured participants who were previously implanted with a scES unit will be enrolled in this study. They will be split into two groups with 10 participants in each. All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria, which are the same for both groups. Participants will then be placed into one of the two groups based on their availability and preference to be enrolled in a longer or shorter study. Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation. Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation.
Each individual will serve as their own control, to reduce variability. All participants will undergo the Stable Standing Assessment, Postural Perturbation Assessment, Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Group 1 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.
- Conditions
- SCI - Spinal Cord Injury
- Being tested
- The Tethered Pelvic Assist Device (TPAD)
- Keywords
- TPAD
- 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.
The Tethered Pelvic Assist Device (TPAD)Device
a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Training and Assessments | Other | 10 SCI participants with an scES implant that will receive 40-60 TPAD training sessions with stimulation and 5 assessments with and without stimulation. Receives: Device: The Tethered Pelvic Assist Device (TPAD) |
| Group 2- Assessments Only | No intervention | 10 SCI participants with an scES implant that will receive 4 assessments with and without stimulation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Recovery Scale (NRS)
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Measured: On average, 2 hours to complete. Group 1will complete the NRS at the beginning of the study and at the end (on average 4 months)
Sitting Assessment
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared between the beginning and end of the study.
Measured: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
Standing Assessment
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after the study.
Measured: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Nov 2024
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A total of 20 spinal cord injured participants who were previously implanted with a spinal cord epidural stimulation (scES) unit will be enrolled and split into two groups with 10 participants in each. All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria, which are the same for both groups. Participants will then be placed into one of the two groups based on their availability and preference. Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation. Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation. Each participant will serve as their own control.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gail Forrest, Kessler Foundation
- Investigators
- Principal Investigator, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650202
- Sponsor's protocol ID
- R-1243-23
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Balance After Spinal Cord Injury Using a Robotic Upright Stand Trainer and Spinal Cord Epidural Stimulation
- ClinicalTrials.gov ID
- NCT06650202
- Acronym / sponsor ID
- R-1243-23
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- TPAD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 21 Oct 2024 (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.
The purpose of this study is to understand how standing and sitting balance control is altered after spinal cord injury and how a new type of robotic assistive device may be used with spinal stimulation to improve muscle function. The investigators will be testing a device called the Tethered Pelvic Asist Device (or "TPAD") in this study. The TPAD may be helpful in two ways. It can be used to help control and support of the trunk, pelvis, and knees during stand training. Also, the TPAD can be used as a training tool by providing controlled "pushes" or "perturbations" that must be corrected by the person with spinal cord injury in order to maintain proper posture and upright balance. This could be helpful for improving muscle function after spinal cord injury.
Participants will be placed into one of two groups based on availability and preference. Group 1 will receive TPAD training with stimulation and assessments with and without stimulation. Participation in this group lasts approximately 4 months. Group 2 will only receive assessments with and without stimulation. Participation in this group last approximately 3 weeks.
Detailed description
The aims of the proposed study are to (a) examine the muscle activation patterns generated during stable and perturbed standing in spinal cord injured individuals using spinal cord epidural stimulation (scES) and robotic TPAD-assistance or self-assistance for balance, and (b and c) to examine the effectiveness of TPAD-assisted stand training in the improvement of postural control during stable and perturbed standing and sitting in spinal cord injured individuals using spinal cord epidural stimulation (scES).
The Tethered Pelvic Assist Device (TPAD) is a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing.
A total of 20 spinal cord injured participants who were previously implanted with a scES unit will be enrolled in this study. They will be split into two groups with 10 participants in each. All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria, which are the same for both groups. Participants will then be placed into one of the two groups based on their availability and preference to be enrolled in a longer or shorter study. Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation. Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation.
Each individual will serve as their own control, to reduce variability. All participants will undergo the Stable Standing Assessment, Postural Perturbation Assessment, Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Group 1 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 20 spinal cord injured participants who were previously implanted with a spinal cord epidural stimulation (scES) unit will be enrolled and split into two groups with 10 participants in each. All participants will undergo a physical examination and classification of their spinal cord injury to determine eligibility criteria, which are the same for both groups. Participants will then be placed into one of the two groups based on their availability and preference. Group 1 will consist of individuals with SCI and an scES implant that will receive TPAD training with stimulation and assessments with and without stimulation. Group 2 will consist of individuals with SCI and an scES implant that will only receive assessments with and without stimulation. Each participant will serve as their own control.
| Arm | Type | Receives |
|---|---|---|
| Group 1- Training and Assessments | Other | Device: The Tethered Pelvic Assist Device (TPAD)10 SCI participants with an scES implant that will receive 40-60 TPAD training sessions with stimulation and 5 assessments with and without stimulation. |
| Group 2- Assessments Only | No intervention | –10 SCI participants with an scES implant that will receive 4 assessments with and without stimulation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Stable medical condition.
- Has a spinal cord injury caused by trauma (fall, car accident, etc.) for at least one year that is not getting worse over time
- Has an implanted spinal cord epidural stimulation unit that is eligible for software upgrade as part of a previous study.
- Unable to stand independently with epidural stimulation turned off.
Key exclusion criteria (10 listed)
- unwilling to discontinue from anti-spasticity medications
- Untreated painful problems with joints, muscles or bones.
- Unhealed fracture.
- Pressure sore or urinary tract infection.
- History of bone disease (except for decreased bone mineral density due to spinal cord injury).
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 |
|---|---|---|
| The Tethered Pelvic Assist Device (TPAD)a light-weight cable-driven robotic stand trainer that (i) can provide assistance-as-needed by applying corrective forces on the trunk and pelvis in response to their movement outside a pre-programmed area, and (ii) can apply controlled forces on the trunk and pelvis to perturb them from their nominal configuration during standing. | Device | Group 1- Training and Assessments |
Primary outcome
Neuromuscular Recovery Scale (NRS)
Time frame: On average, 2 hours to complete. Group 1will complete the NRS at the beginning of the study and at the end (on average 4 months)
Research participants will undergo a series of tasks to test the level of muscle activation and amount of assistance required during standing and stepping in a body-weight supported treadmill environment, as well as overground motor tasks. Arm, trunk/leg movement recovery and independency will be measured by the NRS using 14 motor tasks (sit, reverse sit up, sit up, sitting truck extension, overhead press, forward reach and grasp, door pull and open, can open and manipulation, sit to stand, stand, walking, stand adaptability, step retraining, and step adaptability) and combined with EMG, kinematic, and kinetic analyses on the upper and lower extremities and/or trunk. Based on the performance across categories, 4 phase scores can be assigned:1- greatest impairment relative to normal movement patterns (non-ambulatory), 2- begins to stand and weight support independently, 3- walking with varying skill levels, and 4- normal locomotor and transfer performance with adaptability.
Sitting Assessment
Time frame: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
Research participants will sit on a padded table and perform tasks to challenge their balance control (reaching/shifting weight in multiple directions). Assistance for sitting will be provided at the trunk by the TPAD or by the trainer. EMG and kinematic analysis will be performed on the lower extremities, trunk and upper extremities during sitting. The trunk force and position controller data from the TPAD will be also collected; these data will be synchronized with EMG and kinematic data. Muscle activation patterns will be evaluated recording EMG from different muscle groups. The TPAD/trainer will then generate controlled loss of balance during sitting. EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance will be compared. EMG mean and integrated amplitudes from each muscle will be compared between the beginning and end of the study.
Standing Assessment
Time frame: On average 4 hours to complete. Done at the beginning and end of the study by both groups (group 1: 4 months, group 2: 3 weeks). Repeated by group 1 during training up to 4 times.
Participants will stand as long as possible and undergo a series of standing tasks. Electromyography (EMG), kinematic and kinetic analysis will be performed on the lower extremities and trunk during standing. The pelvic, trunk and knee force and position controller data from the TPAD will be collected and synchronized. Muscle activation patterns will be evaluated recording EMG from different muscle groupings. When appropriate, ground reaction forces will be measured. Blood pressure and heart rate will be measured. The TPAD will then generate controlled loss of balance during standing. Participants will regain balance with/without grasping a fixed object. Investigators will compare EMG onset and burst duration relative to perturbation onset, loss of balance onset and return to balance if applicable. EMG mean and amplitudes from each muscle will be compared before and after the study.
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 30 Apr 2025.
- Individual participant dataSharing planned: No. All Individual Participant Data (IPD) will be kept with the study research team at Kessler Foundation. IPD will be de-identified and may be shared with the device research team at Columbia University, the FDA, Kessler Foundation Institutional Review Board, the Department of Health and Human Services, and collaborators at the Kentucky Spinal Cord Injury Research Center.
Related trials for SCI - Spinal Cord Injury
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Recruiting
Transcutaneous Spinal Cord Stimulation Combined With 4-Aminopyridine and Intensive Rehabilitation in SCI
Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
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.
Principal Investigator principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Tethered Pelvic Assist Device (TPAD) in people with SCI - Spinal Cord Injury, run by Kessler Foundation at 1 site in United States.
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 5 inclusion and 10 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 30 Apr 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 United States. 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 Research Manager (9733243557, LMartinez@KesslerFoundation.Org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular Recovery Scale (NRS) (time frame: On average, 2 hours to complete. Group 1will complete the NRS at the beginning of the study and at the end (on average 4 months)). The study lists 3 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 30 Apr 2025.