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Burke-Hocoma Efficiency Study

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ClinicalTrials.gov Identifier: NCT03555825
Recruitment Status : Unknown
Verified July 2019 by Burke Medical Research Institute.
Recruitment status was:  Enrolling by invitation
First Posted : June 14, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborator:
Hocoma
Information provided by (Responsible Party):
Burke Medical Research Institute

Study Description
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Brief Summary:
The ArmeoSpring device is an exoskeleton (3 joints and 6 degrees of freedom) with integrated springs. The investigators hypothesize that 3 days of training for 6 weeks with the Hocoma Armeo Spring device will be efficient and more effective than one on one ArmeoSpring therapy.

Condition or disease Intervention/treatment Phase
Hemiparesis Hemiplegia Device: Hocoma ArmeoSpring Phase 3

Detailed Description:

In the proposed study, 20 stable subacute and chronic stroke patients will be placed in two groups: 2:1 treatment for 3 weeks (2 patients on 2 robots with one therapist; 60 minutes on robot) then 1 on 1 intervention with the therapist (60 minutes of Hocoma Armeo Spring robotic training) or visa versa. Patients will be assessed using robotic kinematics and standardized occupational therapy motor assessments. The extreme precision afforded by robotic physical rehabilitation therapies makes them an appealing and growing field in rehabilitation.

Determining efficiency of new technologies, while maintaining the highest quality of care, is of priority in the medical field at this time. Devices such as the ArmeoSpring could lead to reduced disability, thereby increasing function and improving quality of life in patients experiencing neurological illness or injury. The ArmeoSpring has potential to decrease cost for both the provider and patient over time while providing more engaging, evidence-based therapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group 1: 60 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy) Group 2: 30 minutes of Armeo treatment, 3 times per week for 6 weeks. (Half the patients will be assigned to 1:1 therapy and the other half to 2:1 therapy)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Burke-Hocoma Efficiency Study
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 60 Minutes ArmeoSpring (1:1)
60 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.
 Device: Hocoma ArmeoSpring
A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Experimental: 60 Minutes ArmeoSpring (2:1)
60 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.
 Device: Hocoma ArmeoSpring
A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Active Comparator: 30 Minutes ArmeoSpring (1:1)
30 minutes of therapy 3x per week for 6 weeks working one-on-one with a clinician for duration of session.
 Device: Hocoma ArmeoSpring
A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
Experimental: 30 Minutes ArmeoSpring (2:1)
30 minutes of therapy 3x per week for 6 weeks with one clinician supervising 2 participants.
 Device: Hocoma ArmeoSpring
A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Upper Extremity Fugl Meyer Assessment [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Impairment measure of gross and fine motor upper extremity movements


Secondary Outcome Measures :
  1. Patient Satisfaction Survey/Enjoyment Scale [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Self-report of experience with device and supervision; 20 question scale with 0= no satisfaction/enjoyment, 100= extremely satisfied

  2. Box and Blocks Test [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Timed measure of gross manual dexterity

  3. Grip Strength [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Measure of force generated by exerting maximal grip

  4. Short Form Health Survey- 36 [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Self-report questionnaire of health status; minimum score of 0= severe disability and 100 = no disability.

  5. Stroke Impact Scale [ Time Frame: Baseline, immediately after intervention, 3 month follow up ]
    Quality of life measure; Consists of 59 items and assesses 8 domains; Minimum score 0= no recovery, Maximum score 100= full recovery


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral or bilateral upper extremity hemiparesis/hemiplegia
  • Upper extremity Fugl-Meyer Assessment Score between 7-60 (Neither hemiplegic nor fully recovered motor function of the shoulder, elbow, wrist)

Exclusion Criteria:

  • Inability to follow 1-2 step commands
  • Fixed joint contracture
  • Unable to tolerate repetitious movement exhibited by pain greater than 5 on Likert Scale
  • Any device dependent restrictions
Contacts and Locations
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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): NCT03555825


Locations
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United States, New York
Burke Medical Research Institute
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Medical Research Institute
Hocoma
Investigators
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Principal Investigator: Tomoko Kitago, MD Burke Medical Research Institute
More Information
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Responsible Party: Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03555825    
Other Study ID Numbers: BRC540
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data available to other researchers at this time.

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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
Additional relevant MeSH terms:
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Hemiplegia
Paresis
Paralysis
Neurologic Manifestations
Nervous System Diseases