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| ID | Type | Description | Link |
|---|---|---|---|
| Protocol#: SPU-09-11 | Other Identifier | JamesJPetersVAMC |
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It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury.
Potential participants will be pre-screened with the inclusion criteria for eligibility. The informed consent process will begin for those participants who have been determined to meet the inclusion criteria. After the potential participant's signed consent has been provided, further evaluations for eligibility will be performed (e.g., there are several medical and physical exclusion criteria). Those potential participants who meet both the inclusion and exclusion criteria will be eligible to enroll into the ReWalk-I study. Baseline evaluations and personalized measurements for fitting to the ReWalk-I will be performed over one week, before the training sessions begin. The ReWalk sessions will consist of a Learning Phase (12 sessions in 4 weeks) and a Training Phase (18 sessions in 6 weeks). These times may vary by each participant's ReWalk learning curve. Training will begin with sit-to-stand, stand-to-sit, and standing balance activities. Progression to walking will occur as skills advance. Each session will be an average 50 minutes, with 3 sessions per week. The skills to be learned include 1) sit-to-stand, 2) stand-to-sit, 3) 2-arm standing balance, 4) 1-arm standing balance, 5) walking, and 6) stair climbing. The study evaluations will be repeated after the Learning Phase, after the Training Phase and 1-month post training follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Powered Exoskeleton | Experimental | persons with SCI trained to use a powered exoskeleton to ambulate overground |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| powered exoskeleton | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Count to Achieve Mobility Skills | 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:
| ReWalk training at 4 and 12 weeks, and 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
Diagnosis of neurological injury other than SCI including:
Severe concurrent medical disease, illness or condition
Recent lower extremity fracture within the past 2 years;
DXA results indicating a t-score below -3.0 and knee BMD <0.70 gm/cm2
Systemic or peripheral infection
Atherosclerosis, congestive heart failure, or history of myocardial infarction
Trunk and/or lower extremity pressure ulcers;
Other illness, that the study physician considers in his/her clinical judgment to be exclusionary
Severe spasticity (defined by an Ashworth score of >4.0 or clinical impression of the study physician or physical therapist)
Significant contractures defined as flexion contracture limited to 35º at the hip and 20º at the knee;
Diagnosis of heterotrophic ossification of the lower extremities;
Femoral neck or the total proximal femur bone mineral density T-scores < -3.0
Psychopathology documentation in the medical record or history of that may conflict with study objectives
Hypertension (SBP>140, DBP>90)
Pregnancy and/or lactating females
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| Name | Affiliation | Role |
|---|---|---|
| Ann M Spungen, EdD | Bronx JJPVAMC CoE 7A-13 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI. | The Bronx | New York | 10468 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33712561 | Derived | Tsai CY, Asselin PK, Hong E, Knezevic S, Kornfeld SD, Harel NY, Spungen AM. Exoskeletal-assisted walking may improve seated balance in persons with chronic spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2021 Mar 12;7(1):20. doi: 10.1038/s41394-021-00384-8. | |
| 33171129 | Derived | Asselin P, Cirnigliaro CM, Kornfeld S, Knezevic S, Lackow R, Elliott M, Bauman WA, Spungen AM. Effect of Exoskeletal-Assisted Walking on Soft Tissue Body Composition in Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2021 Feb;102(2):196-202. doi: 10.1016/j.apmr.2020.07.018. Epub 2020 Nov 7. |
| Label | URL |
|---|---|
| A Study Testing Safety and Tolerance of the ReWalk Exoskeleton Suit (RW) | View source |
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All participants were recruited, consented, screened and eligible subjects were enrolled at the James J Peters VAMC
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| ID | Title | Description |
|---|---|---|
| FG000 | Exoskeleton | Participants trained to use powered exoskeleton for overground ambulation. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exoskeleton | Trained to use powered exoskeleton for overground ambulation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Count to Achieve Mobility Skills | 1. To determine efficacy for mobility defined as the ability to perform the following with the ReWalk-I exoskeletal system, without staff assistance:
| number of participants that were able to achieve the mile stone described in outcome measure description | Posted | Count of Participants | Participants | ReWalk training at 4 and 12 weeks, and 1-month follow-up |
|
4 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exoskeleton | Participants trained to use powered exoskeleton for overground ambulation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin Abrasion / bruising /redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ann Spungen - PI | James J Peters VA Medical Center | 718-584-9000 | 5420 | ann.spungen@va.gov |
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| ID | Term |
|---|---|
| D010264 | Paraplegia |
| D010243 | Paralysis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 26230182 | Derived | Asselin P, Knezevic S, Kornfeld S, Cirnigliaro C, Agranova-Breyter I, Bauman WA, Spungen AM. Heart rate and oxygen demand of powered exoskeleton-assisted walking in persons with paraplegia. J Rehabil Res Dev. 2015;52(2):147-58. doi: 10.1682/JRRD.2014.02.0060. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| 0 |
| 12 |
| 0 |
| 12 |
| 7 |
| 12 |
| Skin abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Lower Back Abraision |
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| R Medial Malleolus Redness | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Abraision / bruising /redness |
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| L Lateral Malleolus Skin Abraision | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Abrasion / bruising /redness |
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| Tailbone Skin Breakdown | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Abrasion/ bruising /redness |
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| R Ischial Area Abasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Abrasion / bruising /redness |
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| L Medial Malleolus Abrasion | Skin and subcutaneous tissue disorders | Systematic Assessment | Skin Abrasion / bruising /redness |
|
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