Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2024-10-22
2028-01-31
Brief Summary
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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
Detailed Description
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Methodology:
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 50 participants will be enrolled in this study; they will be broken into five groups with 10 participants in each. All participants will undergo a physical classification of their spinal cord injury to determine eligibility and which group they belong in. Group 1 will consist of individuals with SCI that can stand independently and will receive TPAD training and assessments, Group 2 will consist of individuals with SCI that cannot stand independently and will receive TPAD training and assessments, Group 3 will consist of individuals with SCI that can stand independently and will receive assessments only, Group 4 will consist of individuals with SCI that cannot stand independently and will receive assessments only, and Group 5 will consist of individuals without a SCI that will receive assessments only. Each individual will serve as their own control, to reduce variability. Motor patterns recorded from the SCI research participants will be also compared to those collected from individuals who do not have a SCI. All participants will undergo the Stable Standing Assessment and Postural Perturbation Assessment. Groups 1, 2, and 5 will additionally perform the Stable Sitting Assessment and Postural Perturbation Assessment in Sitting. Only Groups 1 and 2 will also perform the Neuromuscular Recovery Scale and attend training sessions with the TPAD system.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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
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.
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
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.
Group 3
* Individuals with SCI that can stand independently
* Will undergo standing and posture assessments
* Participation in this group will last about 2 weeks
No interventions assigned to this group
Group 4
* Individuals with SCI that cannot stand independently
* Will undergo standing and posture assessments
* Participation in this group will last about 2 weeks
No interventions assigned to this group
Group 5
* Individuals without a SCI
* Will undergo standing, posture, and sitting assessments
* Participation in this group will last about 2 weeks
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. stable medical condition
3. at least one year post-spinal cord injury (Groups 1-4)
4. non-progressive, traumatic SCI above T10 (Groups 1-4)
5. Injury Grade A, B, C or D (Groups 1-4)
6. ability to stand independently for short periods of time, not exceeding 1 hour (Groups 1 and 3)
7. inability to stand independently (Groups 2 and 4)
Exclusion Criteria
2. untreated painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection
3. history of bone disease unassociated with decreased bone mineral density due to spinal cord injury
4. ongoing drug abuse
5. untreated psychiatric disorders or clinical depression
6. received botox injections in lower extremities in the prior six months
7. Cardiopulmonary disease that may interfere with assessments
8. Untreated severe and persistent dysautonomia
9. Neurological injury or disease (Group 5)
10. Orthopedic injury or condition (Group 5)
18 Years
ALL
Yes
Sponsors
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Kessler Foundation
OTHER
Responsible Party
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Gail Forrest
Associate Director, Tim and Caroline Reynolds Center for Spinal Stimulation
Principal Investigators
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Gail F Forrest, PhD
Role: PRINCIPAL_INVESTIGATOR
Kessler Foundation
Locations
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Kessler Foundation
West Orange, New Jersey, United States
Countries
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Central Contacts
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Gail F Forrest, PhD
Role: CONTACT
Phone: 9733243518
Facility Contacts
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Research Manager
Role: primary
Other Identifiers
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R-1232-23
Identifier Type: -
Identifier Source: org_study_id