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Upper Extremity Rehabilitation With the BURT Robotic Arm

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ClinicalTrials.gov Identifier: NCT03965403
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Paolo Bonato, Spaulding Rehabilitation Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
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
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Wolf Motor Function Test [ Time Frame: Change from baseline scores at 6 weeks ]
    Assessment of upper extremity function

  2. Motor Activity Log [ Time Frame: Change from baseline scores at 6 weeks ]
    Use of upper extremity in daily life

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965403


Contacts
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Contact: Paolo Bonato, PhD 617-952-6319 pbonato@partners.org
Contact: Catherine Adans-Dester 617-952-6321 cadans-dester@partners.org

Locations
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United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02129
Contact: Catherine P Adans-Dester, PT    617-952-6321    cadans-dester@partners.org   
Principal Investigator: Paolo Bonato, PhD         
Sponsors and Collaborators
Spaulding Rehabilitation Hospital

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Responsible Party: Paolo Bonato, Principal Investigator, Director of the Motion Analysis Laboratory, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03965403     History of Changes
Other Study ID Numbers: 2016P002590
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Paolo Bonato, Spaulding Rehabilitation Hospital:
stroke
hemiparesis
Robotic
Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms