Trial Outcomes & Findings for Treatment of Chronic Stroke With AMES + EMG Biofeedback (NCT NCT01116544)
NCT ID: NCT01116544
Last Updated: 2019-11-18
Results Overview
Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
46 participants
Primary outcome timeframe
Within a week of completing all training sessions.
Results posted on
2019-11-18
Participant Flow
Participant milestones
| Measure |
AMES Therapy With EMG Biofeedback
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
|
Overall Study
COMPLETED
|
21
|
22
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
AMES Therapy With EMG Biofeedback
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Treatment of Chronic Stroke With AMES + EMG Biofeedback
Baseline characteristics by cohort
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48 years
STANDARD_DEVIATION 13 • n=93 Participants
|
45 years
STANDARD_DEVIATION 15 • n=4 Participants
|
46 years
STANDARD_DEVIATION 14 • n=27 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Fugl-Meyer Assessment-Upper Limb
|
19.4 units on a scale
STANDARD_DEVIATION 6.2 • n=93 Participants
|
23.1 units on a scale
STANDARD_DEVIATION 8.8 • n=4 Participants
|
21.3 units on a scale
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
Strength Test Flexion
|
16.6 Newton-meters
n=93 Participants
|
18.0 Newton-meters
n=4 Participants
|
17.6 Newton-meters
n=27 Participants
|
|
Strength Test Extension
|
-4.4 Newton-meters
n=93 Participants
|
0.4 Newton-meters
n=4 Participants
|
-0.9 Newton-meters
n=27 Participants
|
|
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
|
51.0 units on a scale
STANDARD_DEVIATION 9.1 • n=93 Participants
|
53.6 units on a scale
STANDARD_DEVIATION 17.0 • n=4 Participants
|
52.3 units on a scale
STANDARD_DEVIATION 9.1 • n=27 Participants
|
|
Stroke Impact Scale (Stroke Recovery)
|
44.0 units on a scale
STANDARD_DEVIATION 23.3 • n=93 Participants
|
48.0 units on a scale
STANDARD_DEVIATION 23.3 • n=4 Participants
|
46.0 units on a scale
STANDARD_DEVIATION 23.1 • n=27 Participants
|
|
Box-and-Block Test
|
0.0 Blocks moved
n=93 Participants
|
0.0 Blocks moved
n=4 Participants
|
0.0 Blocks moved
n=27 Participants
|
PRIMARY outcome
Timeframe: Within a week of completing all training sessions.Population: Chronic stroke with severe hand impairment
Measurement of the change in functional movement of the hand associated with 30 AMES training sessions.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Box and Blocks Test
|
0.0 Number of blocks moved
Interval 0.0 to 1.5
|
0.5 Number of blocks moved
Interval 0.0 to 5.25
|
SECONDARY outcome
Timeframe: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.Population: Chronic stroke with severe upper limb impairment
Scale: Fugl-Meyer Assessment-Motor Function-Upper Limb Measurement of impairment in the upper limb based on tone, range-of-motion, and synergies. Total score in this study includes only the Upper Limb portion of the Motor Function subscale of the assessment, the Upper Limb subset having a scoring range of 0-66, with 0 representing no function and no visible reflexes (i.e., profound plegia) and 66 representing normal motor function.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Fugl-Meyer (UL) Assessment
|
23.7 units on a scale
Standard Deviation 6.2
|
27.0 units on a scale
Standard Deviation 10.3
|
SECONDARY outcome
Timeframe: Within a week of completing all training sessions.Four of 8 possible subscales were used: Physical Problems, Mobility, Hand, and Daily Living, consisting of 26 total questions \[scored from 1 (least impact) to 5 (most impact)\]. The total (summed) raw score for all 4 sub-scales has a minimum of 26 and maximum of 130. The total raw score is then transformed: \[(Actual Raw Score-Lowest Possible Raw Score)/Possible Raw Score Range\] X 100. The minimum transformed score is 0 and the maximum is 100.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Stroke Impact Scale (Physical Problems, Mobility, Hand, ADL)
|
54.0 units on a scale
Standard Deviation 8.1
|
57.4 units on a scale
Standard Deviation 18.0
|
SECONDARY outcome
Timeframe: Within a week of completing all training sessions.A separate section of the Stroke Impact Scale measures self-perception of stroke recovery. Stroke recovery is based on a scale of 0-100, with 0 representing no recovery and 100 representing full recovery.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Stroke Impact Scale (Stroke Recovery)
|
58.3 units on a scale
Standard Deviation 18.2
|
63.3 units on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.Maximum squeezing (i.e., flexion) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Strength Test Flexion
|
21.2 Newton-meters
Interval 10.4 to 30.9
|
30.8 Newton-meters
Interval 16.7 to 41.4
|
SECONDARY outcome
Timeframe: At baseline and again within a week of completing all training sessions. The interval between measurements was 10-12 weeks.Maximum opening (i.e., extension) strength for thumb and fingers at the end of each training session. The participant squeezed the hand as hard as possible 3 times with a 5-10 second rest period between each effort. A single score was calculated for each training session as the average of the 3 efforts. Baseline score was based on the average of the first 3 session scores (i.e., 9 total efforts over the first 3 training sessions). Final score was based on the average of the last 3 training sessions.
Outcome measures
| Measure |
AMES Therapy With EMG Biofeedback
n=21 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=22 Participants
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Strength Test Extension
|
-11.4 Newton-meters
Interval -17.7 to -0.8
|
0.6 Newton-meters
Interval -0.2 to 2.8
|
Adverse Events
AMES Therapy With EMG Biofeedback
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
AMES Therapy With Torque Biofeedback
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMES Therapy With EMG Biofeedback
n=23 participants at risk
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=23 participants at risk
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Hip fracture
|
4.3%
1/23 • Number of events 1 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
0.00%
0/23 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Eye disorders
Scratched cornea
|
4.3%
1/23 • Number of events 1 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
0.00%
0/23 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Cardiac disorders
Flu-like symptoms, high blood pressure
|
4.3%
1/23 • Number of events 1 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
0.00%
0/23 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
Other adverse events
| Measure |
AMES Therapy With EMG Biofeedback
n=23 participants at risk
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of EMG activity the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
AMES Therapy With Torque Biofeedback
n=23 participants at risk
The AMES device provides a 30 minute treatment period of alternating passive flexion and then extension of the hand while vibrators vibrate the muscles of the hand. The subjects job is to attempt to assist the device in the movement. A computer screen will provide visual feedback of the amount of joint torque the subject is able to generate in the hand. Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
13.0%
3/23 • Number of events 5 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
8.7%
2/23 • Number of events 2 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Nervous system disorders
Seizure
|
8.7%
2/23 • Number of events 2 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
0.00%
0/23 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
4.3%
1/23 • Number of events 3 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
8.7%
2/23 • Number of events 2 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Musculoskeletal and connective tissue disorders
Muscle soreness/fatigue
|
4.3%
1/23 • Number of events 1 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
8.7%
2/23 • Number of events 2 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
|
Musculoskeletal and connective tissue disorders
Hand pain
|
0.00%
0/23 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
8.7%
2/23 • Number of events 2 • 2 years, 7 months
Subjects were seen by the Trainer (i.e., treatment specialist) 2-3 times per week. At each training session, the Trainer routinely asked the subject whether he/she had experienced an event since the last session. If so, the occurrence and details were recorded in the Subject Progress Report for that training day. The Site Clinician subsequently made the determination of whether the serious or unanticipated events were related to the study procedures.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place