Trial Outcomes & Findings for Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke (NCT NCT00643864)
NCT ID: NCT00643864
Last Updated: 2022-04-21
Results Overview
The Fugl-Meyer Assessment of Motor Function After Stroke, a widely used scale of motor recovery after stroke. The subscale upper extremity motor function was used. This test requires progressively more complex movements and hand grasps and measure speed and coordination. Each item is graded on a 3-point ordinal scale (0=cannot perform; 1=partially performs; 2=performs fully) with a minimum score of 0 and a maximum score of 66 for the upper extremity. Higher scores indicate better outcome.
TERMINATED
NA
3 participants
preintervention and post intervention
2022-04-21
Participant Flow
Medical outpatient clinic
Participant milestones
| Measure |
Mirror Training
Training will be performed one hour a day, five days per week, Monday through Friday, for four weeks.
|
|---|---|
|
Pre-test Assessment
STARTED
|
3
|
|
Pre-test Assessment
COMPLETED
|
3
|
|
Pre-test Assessment
NOT COMPLETED
|
0
|
|
Post-test Assessment
STARTED
|
3
|
|
Post-test Assessment
COMPLETED
|
3
|
|
Post-test Assessment
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mirror-Box Training in Adults With Chronic Hemiparesis Secondary to Stroke
Baseline characteristics by cohort
| Measure |
Mirror Training
n=3 Participants
Training will be performed one hour a day, five days a week, Monday through friday, for four weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 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
|
2 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
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: preintervention and post interventionThe Fugl-Meyer Assessment of Motor Function After Stroke, a widely used scale of motor recovery after stroke. The subscale upper extremity motor function was used. This test requires progressively more complex movements and hand grasps and measure speed and coordination. Each item is graded on a 3-point ordinal scale (0=cannot perform; 1=partially performs; 2=performs fully) with a minimum score of 0 and a maximum score of 66 for the upper extremity. Higher scores indicate better outcome.
Outcome measures
| Measure |
Mirror Training
n=3 Participants
one group pre post design
|
|---|---|
|
The Fugl-Meyer Assessment of Motor Function After Stroke
Fugl-Meyer Pre
|
45.8 score on a scale
Standard Deviation 12.6
|
|
The Fugl-Meyer Assessment of Motor Function After Stroke
Fugl-Meyer Post
|
58 score on a scale
Standard Deviation 0
|
SECONDARY outcome
Timeframe: preintervention and post interventionThe Arm Motor Ability Test evaluates disabilities in upper extremity function in activities of daily living using a quantitative and qualitative measure. The Functional Ability Scale and the Quality of Movement Scale are rated on an ordinal scale from 0-5. The score for the Functional Ability Scale ranges from 0 to 140. The score for the Quality of Movement Scale ranges from 0 to 140. Higher scores on the Functional Ability and Quality Scale of the Arm Motor Ability Test indicate more normal movement and a better outcome.
Outcome measures
| Measure |
Mirror Training
n=3 Participants
one group pre post design
|
|---|---|
|
Arm Motor Ability Test
Quality Scale Pre
|
90.1 units on a scale
Standard Deviation 33.5
|
|
Arm Motor Ability Test
Functional Ability Post
|
98.5 units on a scale
Standard Deviation 53.0
|
|
Arm Motor Ability Test
Quality Scale Post
|
94.5 units on a scale
Standard Deviation 54.4
|
|
Arm Motor Ability Test
Functional Ability Pre
|
92.8 units on a scale
Standard Deviation 34.8
|
SECONDARY outcome
Timeframe: pre intervention and post interventionPopulation: One group pre post design
The time in seconds to complete 28 tasks is recorded. The tasks are: 1 pick up utensils, 2 cut meat, 3 fork to mouth, 4 pick up sandwich, 5 sandwich to mouth, 6 pick up spoon, 7 bean in spoon, 8 spoon to mouth, 9 grasp mug handle, 10 mug to mouth, 11pick up comb, 12 comb hair, 13 grasp jar top, 14 open jar, 15 tie lace, 16 phone to ear, 17 press phone number, 18 wipe up water, 19 throw away towel, 20 paretic arm in sleeve, 21 button two buttons, 22 arms in T-shirt, 23 shirt over head, 24 straighten shirt, 25 prop on extended arm, 26 turn on light, 27 open door, 28 close door. The total time in seconds to complete all 28 tasks is recorded - as a total summary score. There is no minimum value. There is no maximum value. Lower scores (e.g., less time to complete the 28 tasks) indicate faster performance and better outcome.
Outcome measures
| Measure |
Mirror Training
n=3 Participants
one group pre post design
|
|---|---|
|
Arm Motor Ability Test - Timed
pre intervention
|
330.7 seconds
Standard Deviation 355.4
|
|
Arm Motor Ability Test - Timed
post intervention
|
249.8 seconds
Standard Deviation 257.2
|
Adverse Events
Mirror 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