Trial Outcomes & Findings for Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury (NCT NCT01005615)
NCT ID: NCT01005615
Last Updated: 2023-01-05
Results Overview
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
TERMINATED
PHASE1/PHASE2
19 participants
Baseline
2023-01-05
Participant Flow
1 participant was lost to follow up after consent process and 1 Participant was a screen failure neither were assigned which arm/group they would begin in. total number of participants consented were 19 and 17 were assigned.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Intervention 1
STARTED
|
5
|
12
|
|
Intervention 1
COMPLETED
|
1
|
9
|
|
Intervention 1
NOT COMPLETED
|
4
|
3
|
|
Washout ()
STARTED
|
1
|
9
|
|
Washout ()
COMPLETED
|
1
|
9
|
|
Washout ()
NOT COMPLETED
|
0
|
0
|
|
Intervention 2
STARTED
|
1
|
9
|
|
Intervention 2
COMPLETED
|
1
|
9
|
|
Intervention 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
No FES Cycling
n=5 Participants
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.
|
FES Cycling
n=11 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=16 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
16 Participants
n=16 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=16 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=16 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
15 Participants
n=16 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
11 Participants
n=11 Participants
|
16 Participants
n=16 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
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
Outcome measures
| Measure |
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.
|
FES Cycling
n=5 Participants
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
|
|---|---|---|
|
Severity of Gleno-humeral Subluxation
Left Side IR
|
—
|
2.2156 centimeters
Interval 1.569 to 2.789
|
|
Severity of Gleno-humeral Subluxation
Right Side IR
|
—
|
2.0586 centimeters
Interval 1.525 to 3.036
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
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
Outcome measures
| Measure |
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.
|
FES Cycling
n=5 Participants
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
|
|---|---|---|
|
Severity of Gleno-humeral Subluxation
Left Side
|
—
|
2.0146 centimeters
Interval 1.663 to 2.735
|
|
Severity of Gleno-humeral Subluxation
Right Side
|
—
|
1.9764 centimeters
Interval 1.745 to 2.251
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
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
Outcome measures
| Measure |
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.
|
FES Cycling
n=5 Participants
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
|
|---|---|---|
|
Severity of Gleno-humeral Subluxation
Left Side
|
—
|
2.069 centimeters
Interval 1.652 to 2.312
|
|
Severity of Gleno-humeral Subluxation
Right Side
|
—
|
1.997 centimeters
Interval 1.09 to 3.23
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
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
Outcome measures
| Measure |
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.
|
FES Cycling
n=5 Participants
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
|
|---|---|---|
|
Severity of Gleno-humeral Subluxation
Left Side
|
—
|
1.803 centimeters
Interval 1.421 to 2.161
|
|
Severity of Gleno-humeral Subluxation
Right Side
|
—
|
1.854 centimeters
Interval 1.033 to 2.42
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsThis 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
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=9 Participants
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
|
|---|---|---|
|
Modified Ashworth Scale
Baseline
|
1 score on a scale
Interval 1.0 to 1.0
|
0.333 score on a scale
Interval 0.0 to 1.0
|
|
Modified Ashworth Scale
4th month
|
2 score on a scale
Interval 2.0 to 2.0
|
0.111 score on a scale
Interval 0.0 to 1.0
|
|
Modified Ashworth Scale
5th month
|
3 score on a scale
Interval 3.0 to 3.0
|
0.111 score on a scale
Interval 0.0 to 1.0
|
|
Modified Ashworth Scale
9 month
|
3 score on a scale
Interval 3.0 to 3.0
|
0.333 score on a scale
Interval 0.0 to 1.0
|
|
Modified Ashworth Scale
12 month
|
3 score on a scale
Interval 3.0 to 3.0
|
0.222 score on a scale
Interval 0.0 to 2.0
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsPopulation: Participant did not complete this measure at some time points
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
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=9 Participants
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
|
|---|---|---|
|
Capabilities of the Upper Extremity (CUE) Test
9th month
|
76 score on a scale
Interval 76.0 to 76.0
|
100.33 score on a scale
Interval 32.0 to 216.0
|
|
Capabilities of the Upper Extremity (CUE) Test
Baseline
|
—
|
86.55 score on a scale
Interval 32.0 to 211.0
|
|
Capabilities of the Upper Extremity (CUE) Test
4th month
|
—
|
90.11 score on a scale
Interval 32.0 to 196.0
|
|
Capabilities of the Upper Extremity (CUE) Test
5th month
|
—
|
97.77 score on a scale
Interval 32.0 to 210.0
|
|
Capabilities of the Upper Extremity (CUE) Test
12th month
|
65 score on a scale
Interval 65.0 to 65.0
|
93.22 score on a scale
Interval 32.0 to 212.0
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsPopulation: Majority of the participants were unable to complete this task
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
Outcome measures
| Measure |
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.
|
FES Cycling
n=4 Participants
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
|
|---|---|---|
|
Jebsen-Taylor Hand Function (JTHF) Test
Baseline
|
—
|
12 time in seconds
Interval 9.0 to 17.0
|
|
Jebsen-Taylor Hand Function (JTHF) Test
4th Month
|
—
|
15 time in seconds
Interval 8.0 to 28.0
|
|
Jebsen-Taylor Hand Function (JTHF) Test
5th Month
|
—
|
15 time in seconds
Interval 8.0 to 21.0
|
|
Jebsen-Taylor Hand Function (JTHF) Test
9th Month
|
—
|
11 time in seconds
Interval 5.0 to 23.0
|
|
Jebsen-Taylor Hand Function (JTHF) Test
12th Month
|
—
|
9 time in seconds
Interval 5.0 to 17.0
|
PRIMARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsPopulation: data was only available for 1 subject in the no FES Cycling and that subject scored a Zero
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.
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=4 Participants
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
|
|---|---|---|
|
Box and Blocks (BB) Test
Baseline
|
0 seconds
Interval 0.0 to 0.0
|
36.25 seconds
Interval 21.0 to 53.0
|
|
Box and Blocks (BB) Test
4th Month
|
0 seconds
Interval 0.0 to 0.0
|
42.33 seconds
Interval 20.0 to 58.0
|
|
Box and Blocks (BB) Test
5th Month
|
0 seconds
Interval 0.0 to 0.0
|
39.33 seconds
Interval 15.0 to 60.0
|
|
Box and Blocks (BB) Test
9th Month
|
0 seconds
Interval 0.0 to 0.0
|
38.5 seconds
Interval 19.0 to 59.0
|
|
Box and Blocks (BB) Test
12th month
|
0 seconds
Interval 0.0 to 0.0
|
40 seconds
Interval 19.0 to 56.0
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsPopulation: data was only available for 1 subject in the no FES Cycling and that subject scored a Zero
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
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=4 Participants
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
|
|---|---|---|
|
Action Research Arm (ARA) Test
Baseline
|
0 score on a scale
Interval 0.0 to 0.0
|
36.75 score on a scale
Interval 8.0 to 57.0
|
|
Action Research Arm (ARA) Test
4th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
38 score on a scale
Interval 7.0 to 57.0
|
|
Action Research Arm (ARA) Test
5th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
38.25 score on a scale
Interval 7.0 to 57.0
|
|
Action Research Arm (ARA) Test
9th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
34.25 score on a scale
Interval 2.0 to 57.0
|
|
Action Research Arm (ARA) Test
12th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
36.75 score on a scale
Interval 0.0 to 57.0
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsThis 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
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=9 Participants
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
|
|---|---|---|
|
Range of Motion
9th Month
|
1 units on a scale
Interval 1.0 to 1.0
|
0.67 units on a scale
Interval 0.0 to 1.0
|
|
Range of Motion
Baseline
|
1 units on a scale
Interval 1.0 to 1.0
|
0.67 units on a scale
Interval 0.0 to 1.0
|
|
Range of Motion
4th Month
|
1 units on a scale
Interval 1.0 to 1.0
|
0.67 units on a scale
Interval 0.0 to 1.0
|
|
Range of Motion
5th Month
|
1 units on a scale
Interval 1.0 to 1.0
|
0.67 units on a scale
Interval 0.0 to 1.0
|
|
Range of Motion
12th Month
|
1 units on a scale
Interval 1.0 to 1.0
|
0.67 units on a scale
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: Baseline, 4 months, 5 months, 9 months, 12 monthsThis 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
Outcome measures
| Measure |
No FES Cycling
n=1 Participants
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.
|
FES Cycling
n=9 Participants
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
|
|---|---|---|
|
Numerical Rating Scale (NRS).
Baseline
|
0 score on a scale
Interval 0.0 to 0.0
|
1.67 score on a scale
Interval 0.0 to 8.0
|
|
Numerical Rating Scale (NRS).
4th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
0.78 score on a scale
Interval 0.0 to 7.0
|
|
Numerical Rating Scale (NRS).
5th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
1.89 score on a scale
Interval 0.0 to 7.0
|
|
Numerical Rating Scale (NRS).
9th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
1.56 score on a scale
Interval 0.0 to 7.0
|
|
Numerical Rating Scale (NRS).
12th Month
|
0 score on a scale
Interval 0.0 to 0.0
|
1.11 score on a scale
Interval 0.0 to 7.0
|
Adverse Events
No FES Cycling
FES Cycling
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place