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The Use of Armeo Spring in Upper Extremity Rehabilitation

Primary Purpose

Hemiplegia, Cerebral Palsy, Upper Extremity Weakness

Status
Suspended
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Armeo therapy
Sponsored by
St Mary's Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age between 7 -17 years.
  • Arm weakness secondary to various causes.
  • Armeo®Spring Pediatric fit
  • Upper arm measures:155mm-235mm (7 to 9.5 inches)
  • Lower arm measures: 230mm-370mm (9inches to 14 inches)
  • Ability to follow instructions.

Exclusion Criteria:

  • Vision deficits
  • Contractures that do not allow use of system.
  • Spasticity that does not allow use of system.
  • Osteopenia
  • Recent surgeries to the involved upper extremity.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Armeo

    Arm Description

    Group receiving Armeo therapy

    Outcomes

    Primary Outcome Measures

    Change in hand function
    Box and Blocks test
    Change in hand function
    Jebsen Taylor Hand Function Test
    Change in bimanual hand function
    Assisting hand Assessment

    Secondary Outcome Measures

    Full Information

    First Posted
    December 15, 2015
    Last Updated
    October 12, 2016
    Sponsor
    St Mary's Hospital for Children
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02636205
    Brief Title
    The Use of Armeo Spring in Upper Extremity Rehabilitation
    Official Title
    The Use of Armeo Spring in Upper Extremity Rehabilitation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Suspended
    Why Stopped
    Primary investigator changed. Study protocol may under go change with addition of new investigators.
    Study Start Date
    July 2014 (undefined)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    St Mary's Hospital for Children

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the use of the Armeo®Spring Pediatric as therapy for children with hand and arm weakness. The Armeo®Spring Pediatric is a device that supports the weight of the child's arm and uses joystick that helps to play computer games. The child will be assessed before and after this therapy. Participating children with upper extremity impairments will receive therapy 3x/week for 6 weeks during 30-45 minutes sessions at progressively increasing degrees of difficulty. Each child's performance will be tracked with regard to time necessary to complete a predetermined number of trials of the activity. The standardized assessment tools that will be used are the Assisting Hand Assessment (AHA), Box & Blocks test, Jebsen Taylor hand function test, and the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT). Data will be analyzed to determine the efficacy of this training method.
    Detailed Description
    8. "Adverse Events" All serious adverse events will be reported to the IRB immediately, but no later than [5] days of the occurrence or receipt of notification from an outside source; the IRB can make changes to the consent form as a result of adverse events. Any such event will be reported to the IRB on the "Adverse Event Report." [See attachment.] 9. "Debriefing" Debriefing is not required because there is no deception of subjects involved or there are no alternative treatments or procedures used in a "blind" fashion. 10. "Intervention" Participants in this study are children who present with a diagnosis of upper extremity weakness or involvement secondary to various reasons. These children receive occupational, physical, and/or speech services at St Mary's Hospital for Children. The children participating in this program will be receiving their occupational therapy session with the use of the Armeo®Spring Pediatric. They will also continue to receive their regular physical and speech therapy session. Once the program is completed, they will continue to receive their regular occupation therapy sessions. 11. "Confidentiality" Data sheets will be coded with a number to represent each child. The numeric data obtained regarding timed trials will be entered into a computer which is password-protected at St. Mary's Hospital for Children in Bayside, NY. Consent forms with the child's name and parental signatures and video tape or photographic images recorded during data collection will be stored in accordance with St. Mary's Hospital for Children patient privacy policy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia, Cerebral Palsy, Upper Extremity Weakness

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Armeo
    Arm Type
    Experimental
    Arm Description
    Group receiving Armeo therapy
    Intervention Type
    Device
    Intervention Name(s)
    Armeo therapy
    Intervention Description
    Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.
    Primary Outcome Measure Information:
    Title
    Change in hand function
    Description
    Box and Blocks test
    Time Frame
    baseline and completion (6-8 weeks)
    Title
    Change in hand function
    Description
    Jebsen Taylor Hand Function Test
    Time Frame
    baseline and completion (6-8weeks)
    Title
    Change in bimanual hand function
    Description
    Assisting hand Assessment
    Time Frame
    baseline and completion (6-8 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age between 7 -17 years. Arm weakness secondary to various causes. Armeo®Spring Pediatric fit Upper arm measures:155mm-235mm (7 to 9.5 inches) Lower arm measures: 230mm-370mm (9inches to 14 inches) Ability to follow instructions. Exclusion Criteria: Vision deficits Contractures that do not allow use of system. Spasticity that does not allow use of system. Osteopenia Recent surgeries to the involved upper extremity.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Swetha Krishnaswamy, MS OTR/L
    Organizational Affiliation
    St Mary's Hospital for Children
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    Available IPD and Supporting Information:
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://www.ncbi.nlm.nih.gov/pubmed/25014045
    Available IPD/Information Identifier
    25014045
    Available IPD/Information Type
    Study Protocol
    Available IPD/Information URL
    http://www.ncbi.nlm.nih.gov/pubmed/?term=The+Armeo+Spring+as+training+tool+to+improve+upper+limb+functionality+in+multiple+sclerosis%3A+a+pilot+study
    Available IPD/Information Identifier
    21261965

    Learn more about this trial

    The Use of Armeo Spring in Upper Extremity Rehabilitation

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