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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT02636205
Other study ID # 2014-01
Secondary ID
Status Suspended
Phase N/A
First received December 15, 2015
Last updated October 12, 2016
Start date July 2014
Est. completion date December 2016

Study information

Verified date October 2016
Source St Mary's Hospital for Children
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Suspended
Enrollment 15
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 7 Years to 17 Years
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Armeo therapy
Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
St Mary's Hospital for Children

Outcome

Type Measure Description Time frame Safety issue
Primary Change in hand function Box and Blocks test baseline and completion (6-8 weeks) No
Primary Change in hand function Jebsen Taylor Hand Function Test baseline and completion (6-8weeks) No
Primary Change in bimanual hand function Assisting hand Assessment baseline and completion (6-8 weeks) No
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