Trial Outcomes & Findings for Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation (NCT NCT02092662)
NCT ID: NCT02092662
Last Updated: 2015-08-06
Results Overview
zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.
COMPLETED
57 participants
T1 at the beginning of the hospital stay and folloew up at T2 one month later.
2015-08-06
Participant Flow
Participant milestones
| Measure |
Patients After a Stroke
Patients who admitted to the hospital for rehabilitation after a stroke
|
Control
Healthy voluntiers
|
|---|---|---|
|
Overall Study
STARTED
|
38
|
19
|
|
Overall Study
Recruited
|
38
|
19
|
|
Overall Study
COMPLETED
|
25
|
19
|
|
Overall Study
NOT COMPLETED
|
13
|
0
|
Reasons for withdrawal
| Measure |
Patients After a Stroke
Patients who admitted to the hospital for rehabilitation after a stroke
|
Control
Healthy voluntiers
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
0
|
Baseline Characteristics
Objective Assessment of Upper Extremity Functioning of Stroke Patients Before and After Rehabilitation
Baseline characteristics by cohort
| Measure |
Study
n=38 Participants
patients after a stroke
|
Control
n=19 Participants
healthy volunteers
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Age, Continuous
|
75.15 years
STANDARD_DEVIATION 8.69 • n=99 Participants
|
71 years
STANDARD_DEVIATION 10.58 • n=107 Participants
|
74 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
38 participants
n=99 Participants
|
19 participants
n=107 Participants
|
57 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: T1 at the beginning of the hospital stay and folloew up at T2 one month later.zero to 66 points scale, measuring the impairment level of the upper extremity. Zero indicates a high level of impairment or minimum hand motor function, while 66 points indicates an increased motor function which is similar to normal upper extremity function.
Outcome measures
| Measure |
Study Group (T1)
n=38 Participants
Patients after a stroke
|
Control
n=19 Participants
Healthy age-matched
|
|---|---|---|
|
Fugl-Meyer Assessment.
Fugl-Meyer assessment score (T1)
|
38.32 units on a scale
Standard Deviation 13.77
|
NA units on a scale
Standard Deviation NA
Fugl-Meyer assessment intended to evaluate the motor impairment level after a storle, so it was evaluated only in the study group.
|
|
Fugl-Meyer Assessment.
Fugl-Meyer assessment score (T2)
|
47.6 units on a scale
Standard Deviation 11.06
|
NA units on a scale
Standard Deviation NA
please see T1 assessment above
|
PRIMARY outcome
Timeframe: the study group was assessed T1 at the beginning of the hospital stay and follow up at T2 one month later. The control group assessed for the the time onset and compared to the study group at T1Assessed by surface electromyography device. The time period it takes the muscle to be activated and contract from a voice prompting is measured. Shorter time onset probably charcterized healthy people compared to patients after a stroke.
Outcome measures
| Measure |
Study Group (T1)
n=38 Participants
Patients after a stroke
|
Control
n=19 Participants
Healthy age-matched
|
|---|---|---|
|
Muscle Onset Time.
Biceps T1 assessment
|
1.37 seconds
Standard Deviation 0.7
|
0.79 seconds
Standard Deviation 0.31
|
|
Muscle Onset Time.
Deltoid T1 assessment
|
1.33 seconds
Standard Deviation 0.7
|
0.79 seconds
Standard Deviation 0.32
|
|
Muscle Onset Time.
Deltoid T2 assessment
|
0.9 seconds
Standard Deviation 0.38
|
NA seconds
Standard Deviation NA
The control group used to compare the impairment level of stroke patients to healthy aged matched people, so it was not necessary to make to evaluations for the control group.
|
|
Muscle Onset Time.
Trapezius T1 assessment
|
1.09 seconds
Standard Deviation 0.46
|
0.79 seconds
Standard Deviation 0.3
|
|
Muscle Onset Time.
Trapezius T2 assessment
|
0.8 seconds
Standard Deviation 0.36
|
NA seconds
Standard Deviation NA
The same as above
|
|
Muscle Onset Time.
Biceps T2 assessment
|
0.82 seconds
Standard Deviation 0.4
|
NA seconds
Standard Deviation NA
The same as above
|
|
Muscle Onset Time.
TricepsT1 assessment
|
0.91 seconds
Standard Deviation 0.81
|
0.72 seconds
Standard Deviation 0.64
|
|
Muscle Onset Time.
Triceps T2 assessment
|
1.12 seconds
Standard Deviation 0.74
|
NA seconds
Standard Deviation NA
The same as above
|
SECONDARY outcome
Timeframe: T1 at the beginning of the hospital stay and folloew up at T2 one month later.Assessed by surface electromyography device. Indicate for the level by which muscles contract at the same time and amplitude. It will be calculated in percentage from 100%, as 100% indicate for complete co-activation between a pair of muscles.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: T1 at the beginning of the hospital stay and follow up at T2 one month later.Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The velocity of his writing is measured and pass from the tablet to the computer to be processed by the software.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: The outcome will be measured twice. First at the beginning of the hospital stay and again at the end of the hospital stay, that is 4 weeks on average.T1 at the beginning of the hospital stay and folloew up at T2 one month later.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: T1 at the beginning of the hospital stay and folloew up at T2 one mont...Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks, and the pressure exerted with the pen on the tablet is recorded. The data from the tablet passed to the computer to be processed by the software.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: T1 at the beginning of the hospital stay and folloew up at T2 one mont...Assessed by electronic tablet with specific software called ComPET. Patient make writing tasks. The time the pen is on air is measured. The data from the tablet passed to the computer to be processed by the software.
Outcome measures
Outcome data not reported
Adverse Events
Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place