Trial Outcomes & Findings for Upper Arm Training With Armeo Spring for Stroke (NCT NCT01485354)
NCT ID: NCT01485354
Last Updated: 2017-07-12
Results Overview
The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.
TERMINATED
NA
17 participants
Data collected at baseline and at completion of the 3-week intervention
2017-07-12
Participant Flow
Subjects were recruited primarily among the outpatient population of stroke survivors at Spaulding Rehabilitation Hospital. We primarily relied upon a registry of stroke survivors who had agreed to be contacted for research studies with focus on stroke rehabilitation.
Participant milestones
| Measure |
Armeo Spring Training
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
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|---|---|
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Overall Study
STARTED
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17
|
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Overall Study
COMPLETED
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12
|
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Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Armeo Spring Training
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Overall Study
Withdrawal by Subject
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5
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Baseline Characteristics
Upper Arm Training With Armeo Spring for Stroke
Baseline characteristics by cohort
| Measure |
Armeo Spring Training
n=17 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
|
Sex: Female, Male
Female
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7 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Data collected at baseline and at completion of the 3-week interventionPopulation: Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.
The upper-extremity Fugl-Meyer scale allow one to assess the severity of motor impairments in stroke survivors using a scale from 0 (severe impairment) to 66 (no impairment). It is based on visual observations gathered by asking subjects to perform upper-limb movements using the stroke-affected limb. Therapists rate the performance of the motor tasks using an ordinal scale ranging from 0 (cannot perform) to 2 (can perform fully) that captures the motor ability of the individual. The investigators computed the difference between the Fugl-Meyer score at completion of the 3-week intervention and the Fugl-Meyer score at baseline.
Outcome measures
| Measure |
Armeo Spring Training
n=12 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Change in Upper-extremity Fugl-Meyer Score (Measure of Motor Impairment) (i.e. Difference Between Fugl-Meyer Score at Baseline and at Completion of the 3-week Intervention)
|
6.4 units on a scale
Standard Deviation 6.0
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 3-week interventionPopulation: Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.
The Wolf Motor Function test is designed to assess the severity of functional limitations in stroke survivors. The scale is administered by asking subjects to perform a series of functional movements (e.g. reach for and pick up a paperclip). The outcome of the assessment is the average time needed to perform the motor tasks that are part of the assessment. The score ranges from 0 to 120 s (i.e. if the subject is unable to perform the task, the score for that task is set to 120 s). The investigators computed the difference between the Wolf Motor Function Test score at completion of the 3-week intervention and the Wolf Motor Function Test score at baseline.
Outcome measures
| Measure |
Armeo Spring Training
n=12 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Change in Wolf Motor Function Test Score (a Functional Test) (i.e. Difference Between Wolf Motor Function Test Score at Baseline and at Completion of the 3-week Intervention)
|
6.6 sec
Standard Deviation 12.6
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 3-week interventionPopulation: Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.
The Functional Ability Scale is designed to assess the quality of movement during the performance of a battery of functional tasks. Therapists observe the subject while performing the motor tasks and use an ordinal scale to rate the quality of movement. The scale used to rate each motor task ranges from 0 to 5. The Functional Ability Scale is derived by adding up the scores for each motor task performed by the subject. Subjects perform 15 motor tasks. Hence the Functional Ability Scale score varies from 0 (very poor quality of movement) to 75 (physiological movement). The investigators computed the difference between the Functional Ability Scale score at completion of the 3-week intervention and the Functional Ability Scale score at baseline.
Outcome measures
| Measure |
Armeo Spring Training
n=12 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Change in Functional Ability Scale Score (Scale to Rate Quality of Movement) (i.e. Difference Between Functional Ability Scale Score at Baseline and at Completion of the 3-week Intervention)
|
0.3 units on a scale
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 3-week interventionPopulation: Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.
The Box and Block test is designed to assess manual dexterity in subjects with motor impairments. Subjects are asked to move small wooden blocks from one box to another, moving their stroke-affected arm over a divider between the two boxes. The output of the test is the number of blocks that the subject moves from one box to the other within a set amount of time (i.e. 1 min). Older adults who are otherwise healthy would typically move 60 to 70 blocks in 1 min. Hence, the range of the scale for older adults is 0 to 70. The investigators computed the difference between the Box and Block Test score at completion of the 3-week intervention and the Box and Block Test score at baseline.
Outcome measures
| Measure |
Armeo Spring Training
n=12 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Change in Box and Block Test Score (Manual Dexterity Test) (i.e. Difference Between Box and Block Test Score at Baseline and at Completion of the 3-week Intervention)
|
1.1 number of blocks
Standard Deviation 3.2
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SECONDARY outcome
Timeframe: Data collected at baseline and at completion of the 3-week interventionPopulation: Please notice that we recruited 17 subjects, but 5 subjects withdrew from the study. Herein, we report the results for those subjects who completed the study.
This test is carried out by using a hand dynamometer that measures the grip strength of the individual in kilograms (used as a measure of force). Subjects are instructed to position the thumb on one handle of the dynamometer and the other fingers on the other handle of the dynamometer. The device measures the force generated by the subject using a power grip. The investigators computed the difference between the Grip Strength value at completion of the 3-week intervention and the Grip Strength value at baseline.
Outcome measures
| Measure |
Armeo Spring Training
n=12 Participants
Subjects participated in upper extremity rehabilitation using the Armeo Spring system for a period of 6 weeks. The intervention consisted of 18 training sessions (60 minute sessions, 3 times a week).
Armeo Spring training: Upper-limb training using the Armeo system for a period of 6 weeks
|
|---|---|
|
Change in Grip Strength (Strength Test) (i.e. Difference Between Grip Strength at Baseline and at Completion of the 3-week Intervention)
|
3.0 kg
Standard Deviation 5.2
|
Adverse Events
Armeo Spring Training
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