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The Effect of Combined Armeospring and CIT on Neuro-motor and Functional Recovery in Children With Unilateral CP

NCT02914925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-09-26

No results posted yet for this study

Summary

The purpose of this study is to assess the use of a commercially available arm weight supporting training system (Armeo®Spring) in conjunction with Constraint Induced Therapy (CIT) for improving upper extremity function for children with unilateral cerebral palsy. In addition, the study aims to assess the potential cortical changes with Armeo®Spring therapy and CIT with the use of the Transcranial Magnetic Stimulation (TMS) motor mapping.

This within-subjects repeated-measures study will be conducted at St. Mary's Hospital for Children. Subjects will be recruited from the general population. A sample size of 10 participants is required for the study. Minority and gender distributions of this study are expected to reflect the distributions in the general population of this region.

Therapy: Participating children will have their unaffected arm placed in a sling. The sling is placed at the start of the day and the child is encouraged to have this on during all therapy sessions.The affected arm will be used for repetitive therapeutic activities.Therapy sessions will include activities aimed at building motor learning skills.

TMS will be used to map the brain. Participants will have MRI of the brain that is T1 weighted with 0.9 -1.1 voxel. size to allow for on-screen navigation of the cerebral cortex while performing TMS.The stimulating coil will be held to the scalp over each M1 hemisphere and an induced electrical current passed through the coil will create a magnetic pulse that stimulates the brain

Children will be assessed using functional hand tests and TMS.

Conditions

  • Cerebral Palsy
  • Hemiplegia
  • Upper Extremity Weakness

Interventions

DEVICE

ArmeoSpring/CIT

Participating group will receive therapy with the Armeo®Spring Pediatric and CIT for 6 hours per day, 5 days per week for three weeks, totaling 90 hours

Sponsors & Collaborators

  • St Mary's Hospital for Children

    lead OTHER

Principal Investigators

  • William Watson, Ph.D · St Mary's Hospital for Children

  • Swetha Krishnaswamy, MS OTR/L · St Mary's Hospital for Children

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02914925 on ClinicalTrials.gov