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
About this trial
This is an interventional treatment trial for Hemiplegia
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.
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
NCT ID
NCT02636205
First Posted
December 15, 2015
Last Updated
October 12, 2016
Sponsor
St Mary's Hospital for Children
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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