TPAD for Recovery of Standing After Severe SCI
Tethered Pelvic Assist Device for Recovery of Standing After Severe SCI
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to investigate how standing and sitting balance control is altered after spinal cord injury (SCI) and how a new type of robotic assistive device may be used to improve muscle function. This device is called the Tethered Pelvic Assist Device, or TPAD. The main aims are to: 1\. Examine muscle activation patterns generated during different types of standing in spinal cord injured individuals using robotic assistance or self-assistance for balance 2 and 3. Examine the effectiveness of robotic-assisted stand training in the improvement of posture control during different types of standing and sitting in spinal cord injured individuals. Participants will be placed into one of 5 groups based on a physical classification of their spinal cord injury: Group 1:
- Individuals with SCI that can stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about six months Group 2:
- Individuals with SCI that cannot stand independently
- Will receive TPAD training
- Will undergo standing, posture, sitting, and stepping assessments
- Participation in this group will last about 6 months Group 3:
- Individuals with SCI that can stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks Group 4:
- Individuals with SCI that cannot stand independently
- Will undergo standing and posture assessments
- Participation in this group will last about 2 weeks Group 5:
- Individuals without a SCI
- Will undergo standing, posture, and sitting assessments
- Participation in this group will last about 2 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 18, 2024
CompletedFirst Posted
Study publicly available on registry
October 16, 2024
CompletedStudy Start
First participant enrolled
October 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
December 16, 2024
December 1, 2024
2.9 years
September 18, 2024
December 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 before and after training. Relationships between these parameters will also be calculated and compared with non-disabled data.
On average 4 hours to complete. Done at the beginning of the study for groups 1, 2, and 5. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
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.
On average, 2 hours to complete. Groups 1 and 2 will complete the NRS at the beginning of the study and at the end (on average 6 months).
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 training. The relationship between these parameters will also be calculated and compared with non-disabled data.
On average 4 hours to complete. Done at the beginning of the study for all groups. Repeated by groups 1 & 2 during training (up to 4 times) and at the end of the study (on average 6 months).
Study Arms (5)
Group 1
OTHER* Individuals with SCI that can stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about six months
Group 2
OTHER* Individuals with SCI that cannot stand independently * Will receive TPAD training * Will undergo standing, posture, sitting, and stepping assessments * Participation in this group will last about 6 months
Group 3
NO INTERVENTION* Individuals with SCI that can stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
Group 4
NO INTERVENTION* Individuals with SCI that cannot stand independently * Will undergo standing and posture assessments * Participation in this group will last about 2 weeks
Group 5
NO INTERVENTION* Individuals without a SCI * Will undergo standing, posture, and sitting assessments * Participation in this group will last about 2 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 18 years of age at the time of enrollment;
- stable medical condition
- at least one year post-spinal cord injury (Groups 1-4)
- non-progressive, traumatic SCI above T10 (Groups 1-4)
- Injury Grade A, B, C or D (Groups 1-4)
- ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
- inability to stand independently (Groups 2 and 4)
You may not qualify if:
- unwillingness to wean from anti-spasticity medications;
- untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
- history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
- ongoing drug abuse
- untreated psychiatric disorders or clinical depression
- received botox injections in lower extremities in the prior six months
- Cardiopulmonary disease that may interfere with assessments
- Untreated severe and persistent dysautonomia
- Neurological injury or disease (Group 5)
- Orthopedic injury or condition (Group 5)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Foundation
West Orange, New Jersey, 07052, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gail F Forrest, PhD
Kessler Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director, Tim and Caroline Reynolds Center for Spinal Stimulation
Study Record Dates
First Submitted
September 18, 2024
First Posted
October 16, 2024
Study Start
October 22, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
December 16, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share
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.