Trial Outcomes & Findings for Upper Extremity Rehabilitation With the BURT Robotic Arm (NCT NCT03965403)
NCT ID: NCT03965403
Last Updated: 2020-02-19
Results Overview
Assessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
6 weeks
Results posted on
2020-02-19
Participant Flow
Participant milestones
| Measure |
Arm Motor Function Retraining With BURT
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
|
6
|
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Overall Study
NOT COMPLETED
|
1
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Reasons for withdrawal
| Measure |
Arm Motor Function Retraining With BURT
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
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|---|---|
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Overall Study
Subject not meeting eligibility criteria
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1
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Baseline Characteristics
Upper Extremity Rehabilitation With the BURT Robotic Arm
Baseline characteristics by cohort
| Measure |
Arm Motor Function Retraining With BURT
n=6 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Age, Continuous
|
67.38 years
STANDARD_DEVIATION 3.12 • n=5 Participants
|
|
Sex: Female, Male
Female
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2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksAssessment of upper extremity impairments. Individual items of the scale are summed for a total score ranking from 0 to 66. Higher scores indicate better outcomes.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=6 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Changes From Baseline in Fugl-Meyer Upper Extremity Scores
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3.50 score on a scale
Standard Deviation 5.79
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SECONDARY outcome
Timeframe: 6 weeksStandardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. The Goal Attainment Scale ranges from -2 to +2. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=6 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Changes From Baseline in Goal Attainment Scale Scores
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0.22 score on a scale
Standard Deviation 0.65
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksAssessment of upper-extremity function by the performance time of the Wolf Motor Function Test). The average of the 15 items is reported. The time ranges from 0 to 120 seconds. A decrease in performance time is associated with improved upper-extremity function.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=6 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)
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-6.43 Time (seconds)
Standard Deviation 11.30
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: One study participant did not complete the questionnaire
Use of upper extremity in daily life. The self-reported amount of use is reported on a scale from 0 to 5. A score of zero is assigned when the hemiparetic side is not used during the activity of daily living, a score of 5 is assigned when the hemiparetic side is used as much as before the stroke. The 30 items of the scale are averaged. Higher scores are a sign of better use in daily life.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=5 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
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|---|---|
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Changes From Baseline in Motor Activity Log Scores
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0.42 score on a scale
Standard Deviation 0.46
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: One study participant did not completed this evaluation
Assessment of muscle tone for upper extremity muscles. Score rank from 0 (no tone) to 4 (no movement possible). Lower scores indicates a better outcome. Tone at the shoulder and elbow were measured
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=5 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
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|---|---|
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Changes From Baseline in Modified Ashworth Scale Scores
Shouder flexors
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-0.1 score on a scale
Standard Deviation 0.5
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Changes From Baseline in Modified Ashworth Scale Scores
Shoulder extensors
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0.1 score on a scale
Standard Deviation 0.9
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Changes From Baseline in Modified Ashworth Scale Scores
Elbow flexors
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0.3 score on a scale
Standard Deviation 0.7
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Changes From Baseline in Modified Ashworth Scale Scores
Elbow extensors
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0.1 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Modified Ashworth Scale Scores
Wrist flexors
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-0.6 score on a scale
Standard Deviation 0.8
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Changes From Baseline in Modified Ashworth Scale Scores
Wrist extensors
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-0.2 score on a scale
Standard Deviation 0.8
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Changes From Baseline in Modified Ashworth Scale Scores
Finger flexors
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-0.5 score on a scale
Standard Deviation 0.5
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Changes From Baseline in Modified Ashworth Scale Scores
Finger extensors
|
0.0 score on a scale
Standard Deviation 0.0
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: One study participant did not complete this evaluation
Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=5 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
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|---|---|
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Changes From Baseline in Articulations Range of Motion
Shoulder Flexion
|
5.00 degrees
Standard Deviation 10.61
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Changes From Baseline in Articulations Range of Motion
Shoulder extension
|
14.6 degrees
Standard Deviation 9.8
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Changes From Baseline in Articulations Range of Motion
Shoulder ABD
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5.4 degrees
Standard Deviation 10.9
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Changes From Baseline in Articulations Range of Motion
Shoulder ADD
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3.4 degrees
Standard Deviation 15.6
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Changes From Baseline in Articulations Range of Motion
Shoulder IR
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0 degrees
Standard Deviation 0
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Changes From Baseline in Articulations Range of Motion
Shoulder ER
|
-5 degrees
Standard Deviation 10
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Changes From Baseline in Articulations Range of Motion
Elbow Flexion
|
7.0 degrees
Standard Deviation 10.4
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Changes From Baseline in Articulations Range of Motion
Elbow extension
|
1.0 degrees
Standard Deviation 27.7
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Changes From Baseline in Articulations Range of Motion
Forearm pronation
|
2.0 degrees
Standard Deviation 10.9
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Changes From Baseline in Articulations Range of Motion
Forearm supination
|
7.0 degrees
Standard Deviation 12.0
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Changes From Baseline in Articulations Range of Motion
Wrist extension
|
-2.0 degrees
Standard Deviation 9.1
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Changes From Baseline in Articulations Range of Motion
Wrist flexion
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14.0 degrees
Standard Deviation 12.9
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Changes From Baseline in Articulations Range of Motion
Ulnar flexion
|
5.6 degrees
Standard Deviation 5.2
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Changes From Baseline in Articulations Range of Motion
Radial flexion
|
1.0 degrees
Standard Deviation 10.8
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Changes From Baseline in Articulations Range of Motion
Index flexion
|
9.0 degrees
Standard Deviation 20.1
|
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Changes From Baseline in Articulations Range of Motion
Index extension
|
-5.0 degrees
Standard Deviation 8.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksPopulation: One study participant did not completed this evaluation
Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 10 (maximal strength). Higher scores indicate better outcomes.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=5 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder flexors
|
0.8 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder extensors
|
1.6 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder adductors
|
1.5 score on a scale
Standard Deviation 1.6
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder abductors
|
-0.2 score on a scale
Standard Deviation 1.9
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder internal rotators
|
0.2 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Manual Muscle Testing Scale Scores
Shoulder external rotators
|
0.3 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Manual Muscle Testing Scale Scores
Elbow flexors
|
1.4 score on a scale
Standard Deviation 1.1
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Changes From Baseline in Manual Muscle Testing Scale Scores
Elbow extensors
|
0.8 score on a scale
Standard Deviation 3.6
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Changes From Baseline in Manual Muscle Testing Scale Scores
Forearm pronators
|
1.4 score on a scale
Standard Deviation 3.6
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Changes From Baseline in Manual Muscle Testing Scale Scores
Forearm supinators
|
-0.3 score on a scale
Standard Deviation 1.6
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Changes From Baseline in Manual Muscle Testing Scale Scores
Wrist extension
|
0.1 score on a scale
Standard Deviation 2.6
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Changes From Baseline in Manual Muscle Testing Scale Scores
Wrist flexion
|
1.5 score on a scale
Standard Deviation 3.7
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OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeksAssessment of upper-extremity function with the Functional ability subscale of the Wolf Motor Function Test. The average of the 15 items is reported. Scores ranges from 0 to 5, they rate the quality of the movement performance. 0= do not attempt, up to 5= identical to contralateral side. Higher scores are associated with better movement quality.
Outcome measures
| Measure |
Arm Motor Function Retraining With BURT
n=6 Participants
All participants will receive 1 hour sessions, 2-3x/week for 6 weeks (total 18 sessions). Sessions will be organized with 30 minutes of robotic-assisted training and 30 minutes of hands-on training with a research therapist to work on the baseline goals of the subject. Hands-on training will be done with routinely employed techniques in therapy to transfer the skills gained with the robotic device in everyday life activities.
Arm motor function retraining with BURT: Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
|
|---|---|
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Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)
|
0.26 score on a scale
Standard Deviation 0.37
|
Adverse Events
Arm Motor Function Retraining With BURT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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