| Primary | Severity of Gleno-humeral Subluxation | This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally | no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment. | Posted | | Mean | Full Range | centimeters | | Baseline | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
| | | Title | Denominators | Categories |
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| Left Side IR | | | Title | Measurements |
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| - OG0012.2156(1.569 to 2.789)
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| | Right Side IR | | | Title | Measurements |
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| - OG0012.0586(1.525 to 3.036)
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| Primary | Severity of Gleno-humeral Subluxation | This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally | no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment. | Posted | | Mean | Full Range | centimeters | | 4 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Severity of Gleno-humeral Subluxation | This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally | no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment. | Posted | | Mean | Full Range | centimeters | | 9 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Severity of Gleno-humeral Subluxation | This is a routine exam performed to assess shoulder subluxation. The space between the glenoid and head of the humerus can be visualized on plain X-rays and measured, in centimeters, to grade severity. This test is done bilaterally | no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment. | Posted | | Mean | Full Range | centimeters | | 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Modified Ashworth Scale | This is a routine exam performed for people with spinal cord injury.The Modified Ashworth Scale assesses muscle resistance to passive movement. The evaluator moves the joint through the available range of motion and assigns a score from 0-4, where 0 is no tone and 4 is fixed limb (ordinal scale, [44]).Subjects are tested in a seated position preferably in their wheelchairs. The subjects' upper extremity is stabilized by the examiner above and below the joint to be tested. Then the joint is quickly moved through the previously determined subjects' maximum range of motion | | Posted | | Mean | Full Range | score on a scale | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Capabilities of the Upper Extremity (CUE) Test | This is a routine exam performed for people with spinal cord injury.The CUE test is a 32-item interview. It is designed to self-assess upper extremity performance on a 7-point scale (nominal scale, [45]).Subjects are questioned while sitting in their wheelchairs. A brief description of the test will be read to the subjects and then questions asked, one at a time. Subjects will give verbal responses on a 7-point likert scale. total score possible is 0- 225, higher the score better outcome | Participant did not complete this measure at some time points | Posted | | Mean | Full Range | score on a scale | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Jebsen-Taylor Hand Function (JTHF) Test | This is a routine exam performed for people with spinal cord injury.The JTHF test is a 7-item test designed to objectively assess various hand functions and speed of performance (ordinal scale, [46]). Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The JTHF requires subjects to reach for, lift, and in some cases manipulate small objects. smallest time in seconds mean a better outcome | Majority of the participants were unable to complete this task | Posted | | Mean | Full Range | time in seconds | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Primary | Box and Blocks (BB) Test | This is a routine exam performed for people with spinal cord injury. The BB assesses gross hand function. Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The BB requires subjects to reach for, lift, and move one inch cubes across a divider inside a wooden box. The amount of time (seconds) subject is able to move around is measured. Higher scores mean better outcome by timed test. | data was only available for 1 subject in the no FES Cycling and that subject scored a Zero | Posted | | Mean | Full Range | seconds | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Secondary | Action Research Arm (ARA) Test | This is a routine exam performed for people with spinal cord injury.The ARA test observationally assesses upper extremity function .Subjects are tested in a seated position, preferably from their wheelchairs, in front of a table. Test items will be laid out on the table and the test conducted per the standardized instructions. The ARA requires subjects to handle objects differing in size, weight and shape. Score range is from 0-57, higher the number means better outcome overall | data was only available for 1 subject in the no FES Cycling and that subject scored a Zero | Posted | | Mean | Full Range | score on a scale | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Secondary | Range of Motion | This is a routine exam performed for people with spinal cord injury. Subjects are tested in a seated position, preferably in their wheelchairs. The desired joint is isolated and moved through the maximum available range of motion. Once the end range is reached, joint excursion is measured with a goniometer. This measure is to see if you have any active range of motion. 1 is yes to active range of motion and 0 is no range of motion. Having active range of motion is a better outcome | | Posted | | Mean | Full Range | units on a scale | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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| Secondary | Numerical Rating Scale (NRS). | This is a routine exam performed for people with spinal cord injury. Subjects report how much pain they are having by choosing a number from 0-10, 0 being no pain and 10 being the worst pain | | Posted | | Mean | Full Range | score on a scale | | Baseline, 4 months, 5 months, 9 months, 12 months | | | | ID | Title | Description |
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| OG000 | No FES Cycling | Non-FES Upper Extremity Exercise: While undergoing the non-FES exercise intervention, the subjects will receive a specific, individualized exercise regimen, consisting of strengthening, stretching, splinting and any other therapeutic interventions that do not use electrical stimulation. Than a 1 month washout period,the subjects will remain seated in their primary wheelchair throughout the treatment. The subjects will exercise for 60 minutes/session, three times a week for 4 months. | | OG001 | FES Cycling | RT300-SLSA, from Restorative Therapies, Inc.: They will undergo 4 months of FES assisted upper extremity ergometry followed by 1 month was out period, than by 4 months of a specific, individualized, non FES assisted exercise regimen |
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