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出境医 / 临床实验 / Upper Extremity Rehabilitation With the BURT Robotic Arm

Upper Extremity Rehabilitation With the BURT Robotic Arm

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.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: Arm motor function retraining with BURT Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All participants will receive the same intervention
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
Actual Study Start Date : October 23, 2018
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 16, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: 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.
 Device: 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
Outcome Measures
Primary Outcome Measures :
  1. Changes From Baseline in Fugl-Meyer Upper Extremity Scores [ Time Frame: 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 Outcome Measures :
  1. Changes From Baseline in Goal Attainment Scale Scores [ Time Frame: 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 Outcome Measures:
  1. Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) [ Time Frame: 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.

  2. Changes From Baseline in Motor Activity Log Scores [ Time Frame: 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.

  3. Changes From Baseline in Modified Ashworth Scale Scores [ Time Frame: 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


  4. Changes From Baseline in Articulations Range of Motion [ Time Frame: 6 weeks ]
    Assessment of active arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.

  5. Changes From Baseline in Manual Muscle Testing Scale Scores [ Time Frame: 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.

  6. Changes From Baseline in Wolf Motor Function Test Scores (FAS Subcale) [ Time Frame: 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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
Layout table for location information
United States, Massachusetts
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States, 02129
Sponsors and Collaborators
Spaulding Rehabilitation Hospital
Tracking Information
First Submitted Date  ICMJE April 3, 2019
First Posted Date  ICMJE May 29, 2019
Results First Submitted Date  ICMJE January 10, 2020
Results First Posted Date  ICMJE February 19, 2020
Last Update Posted Date February 19, 2020
Actual Study Start Date  ICMJE October 23, 2018
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2020) 		Changes From Baseline in Fugl-Meyer Upper Extremity Scores [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Fugl-Meyer Upper Extremity Scale [ Time Frame: Change from baseline scores at 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 7, 2020) 		Changes From Baseline in Goal Attainment Scale Scores [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2019) 		Goal Attainment Scale [ Time Frame: Change from baseline scores at 6 weeks ]
Standardized measure of goals selection and scaling to calculate the extend to which the participant's goals are met. Positive scores indicates goals are better than expected, score of 0 indicates goals are met and negative scores indicates goals aren't met.
Current Other Pre-specified Outcome Measures
 (submitted: February 7, 2020)
  • Changes From Baseline in Wolf Motor Function Test Scores (Time Subscale) [ Time Frame: 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 Motor Activity Log Scores [ Time Frame: 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.
  • Changes From Baseline in Modified Ashworth Scale Scores [ Time Frame: 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 [ Time Frame: 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 Manual Muscle Testing Scale Scores [ Time Frame: 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 Wolf Motor Function Test Scores (FAS Subcale) [ Time Frame: 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 23, 2019)
  • Wolf Motor Function Test [ Time Frame: Change from baseline scores at 6 weeks ]
    Assessment of upper extremity function
  • Motor Activity Log [ Time Frame: Change from baseline scores at 6 weeks ]
    Use of upper extremity in daily life
  • Modified Ashworth Scale [ Time Frame: Change from baseline scores at 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.
  • Articulations Range of Motion [ Time Frame: Change from baseline scores at 6 weeks ]
    Assessment of arm range of motion with goniometry. Results are reported in degrees and higher ranges include better outcomes.
  • Manual Muscle Testing Scale [ Time Frame: Change from baseline scores at 6 weeks ]
    Assessment of arm muscle strength using the manual muscle testing scale ranking from 0 (no contraction) to 5 (maximal strength). Higher scores indicate better outcomes.
 
Descriptive Information
Brief Title  ICMJE Upper Extremity Rehabilitation With the BURT Robotic Arm
Official Title  ICMJE Upper Extremity Rehabilitation With the BURT Robotic Arm: a Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
All participants will receive the same intervention
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Stroke
  • Hemiparesis
Intervention  ICMJE Device: 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
Study Arms  ICMJE Experimental: 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.
Intervention: Device: Arm motor function retraining with BURT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 23, 2019) 		7
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2019) 		10
Actual Study Completion Date  ICMJE May 16, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03965403
Other Study ID Numbers  ICMJE 2016P002590
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Paolo Bonato, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Spaulding Rehabilitation Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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