Back to resultsUpper Extremity Rehabilitation With the BURT Robotic Arm
Primary Purpose
Stroke, Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm motor function retraining with BURT
Sponsored by
About this trial
This is an interventional other trial for Stroke focused on measuring stroke, hemiparesis, Robotic
Eligibility Criteria
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
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm motor function retraining with BURT
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03965403
First Posted
April 3, 2019
Last Updated
February 7, 2020
Sponsor
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03965403
Brief Title
Upper Extremity Rehabilitation With the BURT Robotic Arm
Official Title
Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
May 16, 2019 (Actual)
Study Completion Date
May 16, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
stroke, hemiparesis, Robotic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive the same intervention
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm motor function retraining with BURT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Arm motor function retraining with BURT
Intervention Description
Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
Primary Outcome Measure Information:
Title
Changes From Baseline in Fugl-Meyer Upper Extremity Scores
Description
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
Secondary Outcome Measure Information:
Title
Changes From Baseline in Goal Attainment Scale Scores
Description
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
Other Pre-specified Outcome Measures:
Title
Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale)
Description
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
Title
Changes From Baseline in Motor Activity Log Scores
Description
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
Title
Changes From Baseline in Modified Ashworth Scale Scores
Description
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
Title
Changes From Baseline in Articulations Range of Motion
Description
Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
Time Frame
6 weeks
Title
Changes From Baseline in Manual Muscle Testing Scale Scores
Description
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
Title
Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Upper Extremity Rehabilitation With the BURT Robotic Arm
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