NCT02914925

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

September 26, 2016

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

September 21, 2016

Last Update Submit

September 23, 2016

Conditions

Cerebral PalsyHemiplegiaUpper Extremity Weakness

Keywords

CITArmeoSpringTMS

Outcome Measures

Primary Outcomes (4)

  • Change in motor cortical map expansion

    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

    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

    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

    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

Study Arms (1)

ArmeoSpring/CIT

EXPERIMENTAL

Group will receive ArmeoSpring and CIT therapy

Device: ArmeoSpring/CIT

Interventions

ArmeoSpring/CITDEVICE

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

ArmeoSpring/CIT

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William Watson

Queens, New York, 11360, United States

RECRUITING

Related Publications (2)

  • Liepert J, Bauder H, Wolfgang HR, Miltner WH, Taub E, Weiller C. Treatment-induced cortical reorganization after stroke in humans. Stroke. 2000 Jun;31(6):1210-6. doi: 10.1161/01.str.31.6.1210.

    PMID: 10835434BACKGROUND

  • Inguaggiato E, Sgandurra G, Perazza S, Guzzetta A, Cioni G. Brain reorganization following intervention in children with congenital hemiplegia: a systematic review. Neural Plast. 2013;2013:356275. doi: 10.1155/2013/356275. Epub 2013 Dec 3.

    PMID: 24367726BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegiaParesis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Watson, Ph.D

    St Mary's Hospital for Children

    PRINCIPAL INVESTIGATOR

  • Swetha Krishnaswamy, MS OTR/L

    St Mary's Hospital for Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William Watson, Ph.D

CONTACT

718-281-8868wwatson@stmaryskids.org

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
Neuropsychologist

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 26, 2016

Study Start

February 1, 2016

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

September 26, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Locations

US(1)