The Use of Armeo Spring in Upper Extremity Rehabilitation

Cerebral Palsy Clinical Trial

Official title:

The Use of Armeo Spring in Upper Extremity Rehabilitation

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT02636205
• Other study ID #: 2014-01
• 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

• Cerebral Palsy
• Hemiplegia
• Upper Extremity Weakness

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