Trial Outcomes & Findings for Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury (NCT NCT00833105)

NCT ID: NCT00833105

Last Updated: 2019-05-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 13 participants
• Primary outcome timeframe: Prior to training (baseline), after 25 training sessions (about 8 weeks), 3 months post-training
• Results posted on: 2019-05-01

Participant Flow

Participant milestones

Measure	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. AMES 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 lengthened by the finger or wrist movements. 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.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	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. AMES 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 lengthened by the finger or wrist movements. 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.
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	2

Baseline Characteristics

Rehabilitation of the Upper Extremity With Enhanced Proprioceptive Feedback Following Incomplete Spinal Cord Injury

Baseline characteristics by cohort

Measure	AMES Treatment n=13 Participants 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.
Age, Continuous	45.1 years STANDARD_DEVIATION 13.9 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Age at time of injury	41.5 years STANDARD_DEVIATION 14.1 • n=5 Participants
ASIA Motor Key Muscles	15.6 units on a scale STANDARD_DEVIATION 3.6 • n=5 Participants
Time since injury	3.5 years STANDARD_DEVIATION 2.0 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Arms 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.
Grasp Release Test Pre-training	58.5 Objects moved Standard Error 37.9
Grasp Release Test Post-training	72.0 Objects moved Standard Error 40.0
Grasp Release Test 3 Month Follow-up	77.5 Objects moved Standard Error 44.9

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
ASIA Motor Key Muscles Pre-training	15.3 units on a scale Standard Deviation 3.9
ASIA Motor Key Muscles Post-training	14.6 units on a scale Standard Deviation 4.4
ASIA Motor Key Muscles 3 Month Follow-up	16.1 units on a scale Standard Deviation 4.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch Pre-training	14.1 units on a scale Standard Deviation 3.3
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch Post-training	13.8 units on a scale Standard Deviation 3.3
ASIA (ISNCSCI) Sensory/Key Sensory Points/ Light-Touch 3 Month Follow-up	14.5 units on a scale Standard Deviation 3.1

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick Pre-training	10.5 units on a scale Standard Deviation 5.4
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick Post-training	11.3 units on a scale Standard Deviation 5.3
ASIA (ISNCSCI) Sensory/Key Sensory Points/Pin-Prick 3 Month Follow-up	11.1 units on a scale Standard Deviation 4.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Van Lieshout Hand Function Test for Tetraplegia- Short Version Pre-training	27.2 units on a scale Standard Deviation 11.8
Van Lieshout Hand Function Test for Tetraplegia- Short Version Post-training	27.3 units on a scale Standard Deviation 11.1
Van Lieshout Hand Function Test for Tetraplegia- Short Version 3 Month Follow-up	27.4 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Modified Ashworth Scale Pre-training	5.3 units on a scale Standard Deviation 3.4
Modified Ashworth Scale Post-training	4.4 units on a scale Standard Deviation 3.2
Modified Ashworth Scale 3 Month Follow-up	4.2 units on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Capabilities of Upper Extremity Instrument Pre-training	58.2 units on a scale Standard Deviation 23.0
Capabilities of Upper Extremity Instrument Post-training	64.1 units on a scale Standard Deviation 24.6
Capabilities of Upper Extremity Instrument 3 Month Follow-up	63.8 units on a scale Standard Deviation 25.8

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Strength Test - Thumb/Finger Extension Pre-training	0.43 Newton*meters Standard Deviation 0.43
Strength Test - Thumb/Finger Extension Post-training	0.65 Newton*meters Standard Deviation 0.65

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Strength Test - Thumb/Fingers Flexion Pre-training	2.10 Newton*meters Standard Deviation 1.75
Strength Test - Thumb/Fingers Flexion Post-training	2.87 Newton*meters Standard Deviation 2.94

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Strength Test - Wrist Extension Pre-training	2.27 Newton*meters Standard Deviation 1.50
Strength Test - Wrist Extension Post-training	3.51 Newton*meters Standard Deviation 2.02

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Strength Test - Wrist Flexion Pre-training	5.41 Newton*meters Standard Deviation 3.31
Strength Test - Wrist Flexion Post-training	7.95 Newton*meters Standard Deviation 4.98

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Active Motion Test - Fingers/Thumb Pre-training	6.95 Seconds Standard Deviation 5.98
Active Motion Test - Fingers/Thumb Post-training	10.63 Seconds Standard Deviation 7.20

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	AMES Treatment n=15 Upper Limbs 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.
Active Motion Test - Wrist Pre-training	18.50 Seconds Standard Deviation 11.27
Active Motion Test - Wrist Post-training	26.62 Seconds Standard Deviation 11.77

Adverse Events

AMES Treatment

Serious events: 2 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	AMES Treatment n=13 participants at risk 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. AMES 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 lengthened by the finger or wrist movements. 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.
Hepatobiliary disorders Liver disease requiring hospitalization	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Psychiatric disorders Suicide	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)

Other adverse events

Measure	AMES Treatment n=13 participants at risk 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. AMES 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 lengthened by the finger or wrist movements. 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.
Renal and urinary disorders Urinary tract infection	15.4% 2/13 • Number of events 2 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Musculoskeletal and connective tissue disorders Reduction in tenodesis	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Blood and lymphatic system disorders Bleeding	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Skin and subcutaneous tissue disorders Skin abrasion	15.4% 2/13 • Number of events 2 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Musculoskeletal and connective tissue disorders Fall	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)
Musculoskeletal and connective tissue disorders Muscular soreness	7.7% 1/13 • Number of events 1 • Time of enrollment until completing the 3-month follow-up evaluation (i.e., 5-6 months)

Additional Information

Dr. Paul Cordo

Oregon Health & Science University

Phone: 503 418 2520

Email: cordop@ohsu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place