Paresis, Plegia, Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Incomplete Spinal Cord Injury, Rehabilitation, Upper Extremity, AMES device, Incomplete SCI, Quadriplegia
Brief summary
The purpose of this study is to determine if tetraplegic individuals with incomplete spinal cord injury (SCI) who remain unable to move their arms normally 1 year after their SCIs are able to sense and move the affected arm(s) better after 10-13 weeks of treatment with a new robotic therapy device. The hypothesis is that using the AMES device on the arm(s) of chronic tetraplegic subjects with incomplete SCI will result in improved strength, sensation, and functional movement in treated limb(s).
Detailed description
Traumatic spinal cord injury (SCI) affects over 200,000 people in the USA, with several thousand new injuries each year. Most recovery, following SCI, occurs in the six months following surgery. Further recovery after 12 months is unusual. In this study 13 subjects, more than 1 year post injury, were enrolled to test the safety and efficacy of a new type of robotic therapy device known as the AMES device. The aim of this Phase I/II study is to investigate the use of assisted movement and enhanced sensation (AMES) technology in hand rehabilitation of incomplete SCI subjects.
Interventions
DEVICEAMES treatment
The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device.
Sponsors
Shepherd Center, Atlanta GA
Oregon Health and Science University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Traumatic SCI with tetraplegia. * Male or female. * 18-65 yrs old. * At least 1 yr post-SCI. * Tolerate sitting upright at for at least one hour. * Able to perceive direction of passive joint(s) motion of the upper extremity(ies) to be treated 70% or more of the times tested. * Motor grade \>1 in the wrist extensors, finger flexors and finger abductors (the 3 muscles related to hand movements in the ASIA scale) in the upper extremity tested. * Cognitively and behaviorally capable of complying with the regimen.
Exclusion criteria
* Fracture of the treated limb resulting in loss of range of motion * Concomitant TBI or stroke (Patients who sustained mild head injury during the trauma with no evidence of structural abnormalities on brain images will qualify for the study) * DVT of the treated extremity * Peripheral nerve injury of the treated extremity * Osteo- or rheumatoid-arthritis limiting range of motion * Contractures equal to or greater than 50% of the normal ROM * Skin condition not tolerant of device * Progressive neurodegenerative disorder * Botox treatment of the treated extremity in the prior 5 month * Chronic ITB therapy * Uncontrolled seizure disorder * Uncontrolled high blood pressure/angina * Pain in affected limb or exercise intolerance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Grasp Release Test | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ASIA Motor Key Muscles | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb. |
| ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation. |
| ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation. |
| Van Lieshout Hand Function Test for Tetraplegia- Short Version | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance. |
| Modified Ashworth Scale | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment. |
| Capabilities of Upper Extremity Instrument | Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training | Subjective questionnaire of participants' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., totally limited) to 7 (i.e., not at all limited). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function. |
| Strength Test - Thumb/Finger Extension | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Maximum strength of thumb-and-fingers in extension. Pre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training. |
| Strength Test - Thumb/Fingers Flexion | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Maximum strength of Thumb/fingers in Flexion Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training. |
| Strength Test - Wrist Extension | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Maximum wrist strength in extension Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training. |
| Strength Test - Wrist Flexion | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Maximum strength in flexion direction Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training. |
| Active Motion Test - Fingers/Thumb | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant's thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training. |
| Active Motion Test - Wrist | Prior to training (baseline), after each of 25 training sessions (about 3 times/week) | Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant's wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AMES Treatment The subject will receive 25 treatment sessions, conducted 2-3 times per week on the AMES device. Each session will consist of testing followed by 30 minutes of wrist and finger rehabilitation using the AMES device.
The AMES device rotates the fingers-thumb or the wrist in the flexion-extension directions over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that are lengthened by the thumb-finger or hand movement. A treatment consists of 20 minutes of fingers-thumb movement, followed by 10 minutes of wrist movement. The subject's task is to assist the motion of the device. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AMES Treatment |
|---|---|
| Age at time of injury | 41.5 years STANDARD_DEVIATION 14.1 |
| Age, Continuous | 45.1 years STANDARD_DEVIATION 13.9 |
| ASIA Motor Key Muscles | 15.6 units on a scale STANDARD_DEVIATION 3.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 13 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 10 Participants |
| Time since injury | 3.5 years STANDARD_DEVIATION 2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 13 |
| serious Total, serious adverse events | 2 / 13 |
Outcome results
Primary
Grasp Release Test
The task involves picking up, transporting, and placing six objects (i.e., peg, paperweight, fork, block, can, and videotape). Movement of each of the 6 objects is scored based on the number of times the participant can move the object in 30 seconds, with a minimum score of zero if no objects are successfully moved. A cumulative score is based on the sum of all completed movements for all 6 objects.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Grasp Release Test | Pre-training | 58.5 Objects moved | Standard Error 37.9 |
| AMES Treatment | Grasp Release Test | Post-training | 72.0 Objects moved | Standard Error 40 |
| AMES Treatment | Grasp Release Test | 3 Month Follow-up | 77.5 Objects moved | Standard Error 44.9 |
p-value: <0.025Mixed Models Analysis
Secondary
Active Motion Test - Fingers/Thumb
Tracking task for the thumb and finger, i.e., opening and closing the hand. The participant tracks a target box on a video screen by actively moving the thumb and fingers, first in the opening direction, then closing, and finally opeining again. The participant's thumb-and-finger position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Active Motion Test - Fingers/Thumb | Pre-training | 6.95 Seconds | Standard Deviation 5.98 |
| AMES Treatment | Active Motion Test - Fingers/Thumb | Post-training | 10.63 Seconds | Standard Deviation 7.2 |
p-value: <0.001Wilcoxon Signed Rank Test
Secondary
Active Motion Test - Wrist
Tracking task for the wrist, i.e., flexing (i.e., pull with the front of the hand) and extending (i.e., pushing with the back of the hand). The participant tracks a target box on a video screen by actively moving the hand at the wrist, first in the extension direction, then flexion, and finally extension again. The participant's wrist position is represented on the video screen by a vertical line that he/she attempts to keep in the the target box. Performance on this task is scored as the amount of time, in seconds, that the participant keeps the line in the target box. The maximum total score in this test is 60 seconds. The Pre-training Score is the average score obtained during the first 3 days of training, and the Post-training Score is average score obtained during the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Active Motion Test - Wrist | Pre-training | 18.50 Seconds | Standard Deviation 11.27 |
| AMES Treatment | Active Motion Test - Wrist | Post-training | 26.62 Seconds | Standard Deviation 11.77 |
p-value: <0.001Wilcoxon Signed Rank Test
Secondary
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch
Measures the subject's sensory perception, with eyes closed, of a light touch by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch | Pre-training | 14.1 units on a scale | Standard Deviation 3.3 |
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch | Post-training | 13.8 units on a scale | Standard Deviation 3.3 |
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch | 3 Month Follow-up | 14.5 units on a scale | Standard Deviation 3.1 |
p-value: 0.459Mixed Models Analysis
Secondary
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick
Measures the subject's sensory perception, with eyes closed, of a light prick of a safety pin produced by the tester on 9 key sensory points of the hand, arm, shoulder and neck. Sensation at each key point is rated as a number on a scale from 0 (no feeling) to 2 (normal feeling), with a score of 1 representing partly diminished feeling. The overall sensation of the upper limb and nearby areas is represented as the sum of all 9 individual key point scores and, therefore, has an overall range of 0-18, with higher scores representing better sensation.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick | Pre-training | 10.5 units on a scale | Standard Deviation 5.4 |
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick | Post-training | 11.3 units on a scale | Standard Deviation 5.3 |
| AMES Treatment | ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick | 3 Month Follow-up | 11.1 units on a scale | Standard Deviation 4.6 |
p-value: 0.343Mixed Models Analysis
Secondary
ASIA Motor Key Muscles
ISNCSCI Assessment of motor function (upper limb only). Scores on a scale ranging from 0 (i.e., total paralysis) - 5 (i.e., full range of motion) for each of 5 upper limb muscle groups. Total score represents the overall level of the upper limb impairment and represents the sum of the 5 scores from the 5 upper limb muscle groups. Accordingly, the total score has a range of 0-25, with 0 representing a completely paralyzed upper limb and 25 representing a normally functioning upper limb.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | ASIA Motor Key Muscles | 3 Month Follow-up | 16.1 units on a scale | Standard Deviation 4.7 |
| AMES Treatment | ASIA Motor Key Muscles | Pre-training | 15.3 units on a scale | Standard Deviation 3.9 |
| AMES Treatment | ASIA Motor Key Muscles | Post-training | 14.6 units on a scale | Standard Deviation 4.4 |
p-value: 0.299Mixed Models Analysis
Secondary
Capabilities of Upper Extremity Instrument
Subjective questionnaire of participants' self-perceptions of upper limb function that contains 17 questions relating to the use of the right upper limb, the same 17 relating to the use of the lower upper limb, plus two additional questions relating to bimanual function. Responses to each item of the questionnaire has a range of 1 (i.e., totally limited) to 7 (i.e., not at all limited). A total cumulative score used for the study is based on the sum of the responses to all 34 questions (i.e., 16 right arm, 16 left arm, 2 both arms), and therefore has a cumulative score range of 32 - 224, with higher scores indicating more function.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Capabilities of Upper Extremity Instrument | Pre-training | 58.2 units on a scale | Standard Deviation 23 |
| AMES Treatment | Capabilities of Upper Extremity Instrument | Post-training | 64.1 units on a scale | Standard Deviation 24.6 |
| AMES Treatment | Capabilities of Upper Extremity Instrument | 3 Month Follow-up | 63.8 units on a scale | Standard Deviation 25.8 |
p-value: 0.164Mixed Models Analysis
Secondary
Modified Ashworth Scale
Measurement of joint stiffness (tone/spasticity). Score is based on sum of MAS value for 4 muscle groups: (1) Wrist/finger flexors, (2) Wrist/finger extensors, (3) elbow flexors, and (4) elbow extensors. Each muscle group and direction is score on a scale of 0 (no increase in muscle tone) to 5 (rigid), with a score of 2 used instead of 1+. A single overall score representing the sum of all 4 muscle groups and directions is used and has a range of 0-20 with higher scores representing more severe impairment.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Modified Ashworth Scale | Pre-training | 5.3 units on a scale | Standard Deviation 3.4 |
| AMES Treatment | Modified Ashworth Scale | Post-training | 4.4 units on a scale | Standard Deviation 3.2 |
| AMES Treatment | Modified Ashworth Scale | 3 Month Follow-up | 4.2 units on a scale | Standard Deviation 3.3 |
p-value: 0.371Mixed Models Analysis
Secondary
Strength Test - Thumb/Finger Extension
Maximum strength of thumb-and-fingers in extension. Pre-training score is average of a total of 3 scores, including 1 score from each of the first 3 days of training. Post-training score is average of a total of 3 scores, including 1 score from each of the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Strength Test - Thumb/Finger Extension | Pre-training | 0.43 Newton*meters | Standard Deviation 0.43 |
| AMES Treatment | Strength Test - Thumb/Finger Extension | Post-training | 0.65 Newton*meters | Standard Deviation 0.65 |
Comparison: Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.p-value: <0.01Wilcoxon Signed-Rank
Secondary
Strength Test - Thumb/Fingers Flexion
Maximum strength of Thumb/fingers in Flexion Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Strength Test - Thumb/Fingers Flexion | Pre-training | 2.10 Newton*meters | Standard Deviation 1.75 |
| AMES Treatment | Strength Test - Thumb/Fingers Flexion | Post-training | 2.87 Newton*meters | Standard Deviation 2.94 |
p-value: <0.05Wilcoxon Signed Rank Test
Secondary
Strength Test - Wrist Extension
Maximum wrist strength in extension Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Strength Test - Wrist Extension | Pre-training | 2.27 Newton*meters | Standard Deviation 1.5 |
| AMES Treatment | Strength Test - Wrist Extension | Post-training | 3.51 Newton*meters | Standard Deviation 2.02 |
p-value: <0.0001Wilcoxon Signed Rank Test
Secondary
Strength Test - Wrist Flexion
Maximum strength in flexion direction Pre-training score is average of a total of 9 efforts, including 3 efforts from the first 3 days of training. Post-training score is average of a total of 9 efforts, including 3 efforts from the last 3 days of training.
Time frame: Prior to training (baseline), after each of 25 training sessions (about 3 times/week)
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Strength Test - Wrist Flexion | Pre-training | 5.41 Newton*meters | Standard Deviation 3.31 |
| AMES Treatment | Strength Test - Wrist Flexion | Post-training | 7.95 Newton*meters | Standard Deviation 4.98 |
p-value: <0.005Wilcoxon Signed Rank Test
Secondary
Van Lieshout Hand Function Test for Tetraplegia- Short Version
Measures the functional movement in the upper limb of people with cervical spinal cord injury. The short version of this test includes a total of 10 different functional tasks to be performed by the subject with the upper limb. For example, one task is to reach and pick up a filled Coke bottle, set it down, and then replace it in its original position. Each task is scored on a scale of 0-5, 0 representing inability to perform the task and 5 representing normal movement. A single, total score is calculated as the sum of the scores on the 10 tasks, and therefore, has an overall range of 0-50, with higher scores representing better performance.
Time frame: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
Population: Analysis population is arms. Three subjects dropped out. Five of the remaining subjects were tested for both arms.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMES Treatment | Van Lieshout Hand Function Test for Tetraplegia- Short Version | Pre-training | 27.2 units on a scale | Standard Deviation 11.8 |
| AMES Treatment | Van Lieshout Hand Function Test for Tetraplegia- Short Version | Post-training | 27.3 units on a scale | Standard Deviation 11.1 |
| AMES Treatment | Van Lieshout Hand Function Test for Tetraplegia- Short Version | 3 Month Follow-up | 27.4 units on a scale | Standard Deviation 12.6 |
p-value: 0.951Mixed Models Analysis