The Use of Armeo Spring in Upper Extremity Rehabilitation

NCT02636205 | Suspended

• 1 other identifier: 2014-01
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hemiplegia; Cerebral Palsy; Upper Extremity Weakness

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Armeo

EXPERIMENTAL

Group receiving Armeo therapy

Device: Armeo therapy

Interventions

Armeo therapy DEVICE

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

Armeo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Mary's Hospital for Children: lead

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy; Paresis

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Swetha Krishnaswamy, MS OTR/L

  St Mary's Hospital for Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Occupational Therapist

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 21, 2015
• Study Start: July 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share