Hemiparesis, Stroke
Conditions
Keywords
stroke, hemiparesis, Robotic
Brief summary
The overall objective of the proposed study is to carry out usability and design-evaluation assessments of the BURT robotic device for delivering long-term intervention in stroke survivors. The BURT is an upper extremity robotic device that enables the user to see and feel engaging games that encourage intensive therapy. The investigators intend to recruit up to 10 stroke survivors over the course of the study. Participants will train their arm with the BURT for 18 sessions over approximately 6 weeks then participate in a question/answer formatted discussion with research staff to discuss the usability of the device. The investigators will also assess participant's arm function at baseline and after the training sessions.
Interventions
DEVICEArm 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
Sponsors
Spaulding Rehabilitation Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All participants will receive the same intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Male and female, age 18-80; * Having had a stroke (ischemic or hemorrhagic) at least 6 months prior to study * Moderate to severe upper-limb motor impairments (score of 15-45 out of 66 on the Fugl- Meyer Scale); * Community dwelling; * Able to physically fit in the device.
Exclusion criteria
* Current participation in rehabilitation program targeting upper extremity function; * Cognitive impairment resulting to inability to follow instructions or inability to sustain attention for more than 10 minutes; * Visual impairments not corrected with lenses (visual loss); * Aphasia sufficient to limit comprehension and completion of the treatment protocol; * No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy; * Increased muscle tone (passive movement is difficult); * Previous diagnosis of neurological diseases other than stroke; * Other conditions affecting function of the stroke affected upper limb; * Individuals who present with the following: open wounds, fragile skin, active infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Fugl-Meyer Upper Extremity Scores | 6 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Goal Attainment Scale Scores | 6 weeks | Standardized 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Modified Ashworth Scale Scores | 6 weeks | 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 |
| Changes From Baseline in Articulations Range of Motion | 6 weeks | Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes. |
| Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) | 6 weeks | Assessment 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. |
| Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) | 6 weeks | Assessment 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. |
| Changes From Baseline in Manual Muscle Testing Scale Scores | 6 weeks | 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. |
| Changes From Baseline in Motor Activity Log Scores | 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Subject not meeting eligibility criteria | 1 |
Baseline characteristics
| Characteristic | Arm Motor Function Retraining With BURT |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 67.38 years STANDARD_DEVIATION 3.12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Changes From Baseline in Fugl-Meyer Upper Extremity Scores
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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Fugl-Meyer Upper Extremity Scores | 3.50 score on a scale | Standard Deviation 5.79 |
Secondary
Changes From Baseline in Goal Attainment Scale Scores
Standardized 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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Goal Attainment Scale Scores | 0.22 score on a scale | Standard Deviation 0.65 |
Other Pre-specified
Changes From Baseline in Articulations Range of Motion
Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
Time frame: 6 weeks
Population: One study participant did not complete this evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder Flexion | 5.00 degrees | Standard Deviation 10.61 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder extension | 14.6 degrees | Standard Deviation 9.8 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder ABD | 5.4 degrees | Standard Deviation 10.9 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder ADD | 3.4 degrees | Standard Deviation 15.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder IR | 0 degrees | Standard Deviation 0 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Shoulder ER | -5 degrees | Standard Deviation 10 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Elbow Flexion | 7.0 degrees | Standard Deviation 10.4 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Elbow extension | 1.0 degrees | Standard Deviation 27.7 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Forearm pronation | 2.0 degrees | Standard Deviation 10.9 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Forearm supination | 7.0 degrees | Standard Deviation 12 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Wrist extension | -2.0 degrees | Standard Deviation 9.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Wrist flexion | 14.0 degrees | Standard Deviation 12.9 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Ulnar flexion | 5.6 degrees | Standard Deviation 5.2 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Radial flexion | 1.0 degrees | Standard Deviation 10.8 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Index flexion | 9.0 degrees | Standard Deviation 20.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Articulations Range of Motion | Index extension | -5.0 degrees | Standard Deviation 8.7 |
Other Pre-specified
Changes From Baseline in Manual Muscle Testing Scale Scores
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.
Time frame: 6 weeks
Population: One study participant did not completed this evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Forearm pronators | 1.4 score on a scale | Standard Deviation 3.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder flexors | 0.8 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder extensors | 1.6 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder adductors | 1.5 score on a scale | Standard Deviation 1.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder abductors | -0.2 score on a scale | Standard Deviation 1.9 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder internal rotators | 0.2 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Shoulder external rotators | 0.3 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Elbow flexors | 1.4 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Elbow extensors | 0.8 score on a scale | Standard Deviation 3.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Forearm supinators | -0.3 score on a scale | Standard Deviation 1.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Wrist extension | 0.1 score on a scale | Standard Deviation 2.6 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Manual Muscle Testing Scale Scores | Wrist flexion | 1.5 score on a scale | Standard Deviation 3.7 |
Other Pre-specified
Changes From Baseline in Modified Ashworth Scale Scores
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
Time frame: 6 weeks
Population: One study participant did not completed this evaluation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Wrist flexors | -0.6 score on a scale | Standard Deviation 0.8 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Shouder flexors | -0.1 score on a scale | Standard Deviation 0.5 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Shoulder extensors | 0.1 score on a scale | Standard Deviation 0.9 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Elbow flexors | 0.3 score on a scale | Standard Deviation 0.7 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Elbow extensors | 0.1 score on a scale | Standard Deviation 1.1 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Wrist extensors | -0.2 score on a scale | Standard Deviation 0.8 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Finger flexors | -0.5 score on a scale | Standard Deviation 0.5 |
| Arm Motor Function Retraining With BURT | Changes From Baseline in Modified Ashworth Scale Scores | Finger extensors | 0.0 score on a scale | Standard Deviation 0 |
Other Pre-specified
Changes From Baseline in Motor Activity Log Scores
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.
Time frame: 6 weeks
Population: One study participant did not complete the questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Motor Activity Log Scores | 0.42 score on a scale | Standard Deviation 0.46 |
Other Pre-specified
Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)
Assessment 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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) | 0.26 score on a scale | Standard Deviation 0.37 |
Other Pre-specified
Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)
Assessment 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.
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm Motor Function Retraining With BURT | Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) | -6.43 Time (seconds) | Standard Deviation 11.3 |