Spinal Cord Injury
Conditions
Brief summary
To determine whether functional electrical stimulation (FES) promotes neurological and physical recovery in patients with spinal cord injury (SCI). The researchers will investigate the extent of functional recovery in patients with spinal cord injury who receive functional electrical stimulation in the upper extremities compared with patients who do not receive FES.
Detailed description
A randomized, controlled, single-blinded, in-subject controlled (A-B type) trial will be performed in patients with SCI receiving an upper extremities non-FES assisted exercise protocol compared with patients receiving upper extremities ergometry in combination with FES. Neurological and functional outcome measures will be obtained at baseline (time 0), after 1st 4 months of intervention (4 months), after 1 month washout (5 months),after 2nd 4 months intervention (9 months), and 3 month after completing the last intervention (12 months).
Interventions
DEVICENon-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.
DEVICERT300-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
Sponsors
U.S. Army Medical Research and Development Command
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male, Female, age 18-55, all ethnic groups * Spinal Cord Injury, traumatic and non-traumatic * C1-C6 neurological level * ASIA class A-B * Chronic injury \> 12 months and \< 20 years from the injury * No upper-extremity electrical stimulation in the previous 4 weeks * Subjects are medically stable, with no recent (1 month or less) inpatient admission for acute medical or surgical issues * Baseline physical activity is kept stable * Pain and antispasticity medications dose are kept stable * Subjects are legally able to make their own health care decisions
Exclusion criteria
* Associated lower motor neuron/peripheral nerve injury in the C1-C6 levels * Presence of pacemaker * Presence of cancer * History of seizures * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Box and Blocks (BB) Test | Baseline, 4 months, 5 months, 9 months, 12 months | 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. |
| Modified Ashworth Scale | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
| Capabilities of the Upper Extremity (CUE) Test | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
| Jebsen-Taylor Hand Function (JTHF) Test | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
| Severity of Gleno-humeral Subluxation | Baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Range of Motion | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
| Numerical Rating Scale (NRS). | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
| Action Research Arm (ARA) Test | Baseline, 4 months, 5 months, 9 months, 12 months | 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 |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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 | 11 |
| Total | 16 |
Baseline characteristics
| Characteristic | FES Cycling | Total | No FES Cycling |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 16 Participants | 5 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 11 Participants | 16 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 11 Participants | 15 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 0 / 14 | 0 / 12 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 |
Outcome results
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.
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
Population: data was only available for 1 subject in the no FES Cycling and that subject scored a Zero
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Box and Blocks (BB) Test | 4th Month | 0 seconds |
| No FES Cycling | Box and Blocks (BB) Test | 9th Month | 0 seconds |
| No FES Cycling | Box and Blocks (BB) Test | Baseline | 0 seconds |
| No FES Cycling | Box and Blocks (BB) Test | 12th month | 0 seconds |
| No FES Cycling | Box and Blocks (BB) Test | 5th Month | 0 seconds |
| FES Cycling | Box and Blocks (BB) Test | 12th month | 40 seconds |
| FES Cycling | Box and Blocks (BB) Test | 4th Month | 42.33 seconds |
| FES Cycling | Box and Blocks (BB) Test | 5th Month | 39.33 seconds |
| FES Cycling | Box and Blocks (BB) Test | 9th Month | 38.5 seconds |
| FES Cycling | Box and Blocks (BB) Test | Baseline | 36.25 seconds |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
Population: Participant did not complete this measure at some time points
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 9th month | 76 score on a scale |
| No FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 12th month | 65 score on a scale |
| FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 5th month | 97.77 score on a scale |
| FES Cycling | Capabilities of the Upper Extremity (CUE) Test | Baseline | 86.55 score on a scale |
| FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 9th month | 100.33 score on a scale |
| FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 12th month | 93.22 score on a scale |
| FES Cycling | Capabilities of the Upper Extremity (CUE) Test | 4th month | 90.11 score on a scale |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
Population: Majority of the participants were unable to complete this task
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Cycling | Jebsen-Taylor Hand Function (JTHF) Test | Baseline | 12 time in seconds |
| FES Cycling | Jebsen-Taylor Hand Function (JTHF) Test | 4th Month | 15 time in seconds |
| FES Cycling | Jebsen-Taylor Hand Function (JTHF) Test | 5th Month | 15 time in seconds |
| FES Cycling | Jebsen-Taylor Hand Function (JTHF) Test | 9th Month | 11 time in seconds |
| FES Cycling | Jebsen-Taylor Hand Function (JTHF) Test | 12th Month | 9 time in seconds |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Modified Ashworth Scale | Baseline | 1 score on a scale |
| No FES Cycling | Modified Ashworth Scale | 5th month | 3 score on a scale |
| No FES Cycling | Modified Ashworth Scale | 9 month | 3 score on a scale |
| No FES Cycling | Modified Ashworth Scale | 12 month | 3 score on a scale |
| No FES Cycling | Modified Ashworth Scale | 4th month | 2 score on a scale |
| FES Cycling | Modified Ashworth Scale | 12 month | 0.222 score on a scale |
| FES Cycling | Modified Ashworth Scale | Baseline | 0.333 score on a scale |
| FES Cycling | Modified Ashworth Scale | 4th month | 0.111 score on a scale |
| FES Cycling | Modified Ashworth Scale | 5th month | 0.111 score on a scale |
| FES Cycling | Modified Ashworth Scale | 9 month | 0.333 score on a scale |
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
Time frame: 9 months
Population: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Cycling | Severity of Gleno-humeral Subluxation | Left Side | 2.069 centimeters |
| FES Cycling | Severity of Gleno-humeral Subluxation | Right Side | 1.997 centimeters |
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
Time frame: Baseline
Population: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Cycling | Severity of Gleno-humeral Subluxation | Left Side IR | 2.2156 centimeters |
| FES Cycling | Severity of Gleno-humeral Subluxation | Right Side IR | 2.0586 centimeters |
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
Time frame: 4 months
Population: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Cycling | Severity of Gleno-humeral Subluxation | Left Side | 2.0146 centimeters |
| FES Cycling | Severity of Gleno-humeral Subluxation | Right Side | 1.9764 centimeters |
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
Time frame: 12 months
Population: no participants in the no FES cycling arm completed this assessment. 5 participants in the FES cycling arm completed this assessment.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FES Cycling | Severity of Gleno-humeral Subluxation | Left Side | 1.803 centimeters |
| FES Cycling | Severity of Gleno-humeral Subluxation | Right Side | 1.854 centimeters |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
Population: data was only available for 1 subject in the no FES Cycling and that subject scored a Zero
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Action Research Arm (ARA) Test | 4th Month | 0 score on a scale |
| No FES Cycling | Action Research Arm (ARA) Test | 9th Month | 0 score on a scale |
| No FES Cycling | Action Research Arm (ARA) Test | 5th Month | 0 score on a scale |
| No FES Cycling | Action Research Arm (ARA) Test | 12th Month | 0 score on a scale |
| No FES Cycling | Action Research Arm (ARA) Test | Baseline | 0 score on a scale |
| FES Cycling | Action Research Arm (ARA) Test | 12th Month | 36.75 score on a scale |
| FES Cycling | Action Research Arm (ARA) Test | Baseline | 36.75 score on a scale |
| FES Cycling | Action Research Arm (ARA) Test | 4th Month | 38 score on a scale |
| FES Cycling | Action Research Arm (ARA) Test | 5th Month | 38.25 score on a scale |
| FES Cycling | Action Research Arm (ARA) Test | 9th Month | 34.25 score on a scale |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Numerical Rating Scale (NRS). | 4th Month | 0 score on a scale |
| No FES Cycling | Numerical Rating Scale (NRS). | 9th Month | 0 score on a scale |
| No FES Cycling | Numerical Rating Scale (NRS). | 5th Month | 0 score on a scale |
| No FES Cycling | Numerical Rating Scale (NRS). | 12th Month | 0 score on a scale |
| No FES Cycling | Numerical Rating Scale (NRS). | Baseline | 0 score on a scale |
| FES Cycling | Numerical Rating Scale (NRS). | 12th Month | 1.11 score on a scale |
| FES Cycling | Numerical Rating Scale (NRS). | Baseline | 1.67 score on a scale |
| FES Cycling | Numerical Rating Scale (NRS). | 4th Month | 0.78 score on a scale |
| FES Cycling | Numerical Rating Scale (NRS). | 5th Month | 1.89 score on a scale |
| FES Cycling | Numerical Rating Scale (NRS). | 9th Month | 1.56 score on a scale |
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
Time frame: Baseline, 4 months, 5 months, 9 months, 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| No FES Cycling | Range of Motion | Baseline | 1 units on a scale |
| No FES Cycling | Range of Motion | 4th Month | 1 units on a scale |
| No FES Cycling | Range of Motion | 12th Month | 1 units on a scale |
| No FES Cycling | Range of Motion | 5th Month | 1 units on a scale |
| No FES Cycling | Range of Motion | 9th Month | 1 units on a scale |
| FES Cycling | Range of Motion | 9th Month | 0.67 units on a scale |
| FES Cycling | Range of Motion | Baseline | 0.67 units on a scale |
| FES Cycling | Range of Motion | 5th Month | 0.67 units on a scale |
| FES Cycling | Range of Motion | 4th Month | 0.67 units on a scale |
| FES Cycling | Range of Motion | 12th Month | 0.67 units on a scale |