The Use of Armeo Spring in Upper Extremity Rehabilitation

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.

Study Overview

• Status: Suspended
• Conditions: Cerebral Palsy; Hemiplegia; Upper Extremity Weakness
• Intervention / Treatment: Device: Armeo therapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Armeo; Group receiving Armeo therapy	Device: Armeo therapy; Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hand function	Box and Blocks test	baseline and completion (6-8 weeks)
Change in hand function	Jebsen Taylor Hand Function Test	baseline and completion (6-8weeks)
Change in bimanual hand function	Assisting hand Assessment	baseline and completion (6-8 weeks)

Collaborators and Investigators

• Sponsor: St Mary's Hospital for Children
• Investigators: Principal Investigator: Swetha Krishnaswamy, MS OTR/L, St Mary's Hospital for Children

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): September 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: December 15, 2015
• First Submitted That Met QC Criteria: December 18, 2015
• First Posted (Estimate): December 21, 2015

Study Record Updates

• Last Update Posted (Estimate): October 13, 2016
• Last Update Submitted That Met QC Criteria: October 12, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Paralysis; Cerebral Palsy; Hemiplegia
• Other Study ID Numbers: 2014-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Study Data/Documents

1. Study Protocol
   Information identifier: 25014045
2. Study Protocol
   Information identifier: 21261965