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

September 23, 2016 updated by: William Watson, St Mary's Hospital for Children

The Effect of Combined Armeospring Pediatric and Constraint Induced Therapy on Neuro-motor and Functional Recovery in Children With Unilateral Cerebral Palsy

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: This study will evaluate the effect of combined Armeo®spring pediatric and Constraint Induced Therapy on neuro-motor and functional recovery in children with unilateral cerebral palsy.

Background: Children with unilateral cerebral palsy (CP) tend not to use their impaired arm and hand throughout life. This disuse of a limb during postnatal development can stunt the activity-dependent structural and functional development of the motor system. Enabling young children to more readily use their affected extremity is likely to increase the competitive ability of the affected side and can improve the functional and anatomical integrity of the motor system.

Several studies have shown that applying a restraint to the less affected hand with intensive repetitive use of the more affected hand has significant effect in overcoming learned non-use. There is evidence that suggests that CIT produced significant cortical reorganization in adults with chronic and sub-acute cerebrovascular accident (CVA) and patients with chronic traumatic brain injury and for the lower limb of patients with CVA.

The associations between motor physiology and motor performance in children with hemiplegic CP are being examined. Recent study shows that children whose impaired hand is controlled by contralateral connections from the unaffected motor cortex show greater improvement to intensive hand training than children whose impaired hand is controlled by ipsilateral connections from the affected motor cortex.

In order for future therapies to be applied selectively to brain regions most important in mediating recovery, it is important to determine the location of plastic changes produced by intensive practice.

Subject Population: Children with CP Hemiplegia

Design: Participating children enrolled will engage in intensive CI therapeutic activities along with 30-45 minutes of Armeo®Spring based activities at progressively increasing levels of difficult, 6 h/day for 5 days a week for three weeks. Each child's performance will be tracked and activities will be modified based on performance.

Hand function would be assessed using functional hands test (AHA, Box & Blocks test, Jebsen Taylor hand function test) and TMS at three time points: before, after and six months after completion of the training protocol.

Outcome measures: Outcome variables of TMS will be measures of corticomotor excitability using single-pulse TMS. Motor evoked potentials (MEPs) will be recorded via surface electromyography (EMG).

Significance: Understanding how rehabilitation can modulate brain areas associated with motor deficits in CP.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Queens, New York, United States, 11360
        • Recruiting
        • William Watson
        • Contact:
        • Principal Investigator:
          • William Watson, Ph.D
        • Principal Investigator:
          • Swetha Krishnaswamy, MS OTR/L
        • Sub-Investigator:
          • Hilary Berlin, MD
        • Sub-Investigator:
          • Dawn Cuglietto, Psy.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with diagnosis of CP hemiplegia
  • Children that meet Armeo®Spring Pediatric fit criteria
  • Upper arm measures:155mm-235mm (7 to 9.5 inches)
  • Lower arm measures: 230mm-370mm
  • Children that have the ability to follow instructions.

Exclusion Criteria:

  • Severe cognitive deficits
  • Children with any current medical illness unrelated to CP
  • Children with previous episode of neurocardiogenic syncope
  • Children with visual problems uncorrected by glasses and contact lens
  • History of Botulinum toxin or surgical intervention to the relevant extremity in the previous 6 months
  • Children with severe spasticity
  • Children with severe spontaneous movements-ataxia, myoclonic jerks, dyskinesia
  • History of seizure beyond age 2
  • History of bone instability, shoulder joint subluxation or pain
  • Any child on anti-seizure medications or history of epilepsy in self or first degree relatives
  • Any child who has serious heart disease, structural brain lesion,increased intracranial pressure, or has had brain surgery Any child with metals in the body such as cranial metal implants, pacemaker, medication pump, cochlear implant, implanted brain stimulator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ArmeoSpring/CIT
Group will receive ArmeoSpring and CIT therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in motor cortical map expansion
Time Frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Transcranial Magnetic Stimulation (TMS)
Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in hand function
Time Frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Box and Blocks test
Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in hand function
Time Frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Jebsen Taylor Hand Function Test
Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Change in bimanual hand function
Time Frame: Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy
Assisting Hand Assessment
Baseline (within week prior to 3-week intervention), Post-intervention (up to 1 week after 3 week therapy intervention is completed) and 6 months after therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St Mary's Hospital for Children

Investigators

  • Principal Investigator: Swetha Krishnaswamy, MS OTR/L, St Mary's Hospital for Children
  • Principal Investigator: William Watson, Ph.D, St Mary's Hospital for Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Anticipated)

January 1, 2018

Study Completion (Anticipated)

January 1, 2018

Study Registration Dates

First Submitted

September 21, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Estimate)

September 26, 2016

Last Update Submitted That Met QC Criteria

September 23, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMH-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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