Recruiting

Armeospring & CIT

Sponsor:

St Mary's Hospital for Children

Code:

NCT02914925

Conditions

Cerebral Palsy

Hemiplegia

Upper Extremity Weakness

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

Interventions

ArmeoSpring/CIT

Study Details

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.

Conditions

Cerebral Palsy

Hemiplegia

Upper Extremity Weakness

Study ID

NCT02914925

Start date

Feb, 2016

Status verified date

Sep, 2016

Completion date

Jan, 2018

Anticipated

Primary completion date

Jan, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 7 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ArmeoSpring/CIT

Group will receive ArmeoSpring and CIT therapy

Interventions

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

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

William Watson, Ph.D

718-281-8868wwatson@stmaryskids.org

Locations

William Watson

Recruiting

Queens, New York, United States, 11360

Contacts

William Watson, Ph.D

718-281-8868wwatson@stmaryskids.org

Principal Investigator:

William Watson, Ph.D

More Information

Sponsor

St Mary's Hospital for Children

Last update posted

Sep 26, 2016

Last verified

Sep, 2016

Keywords

  • CIT
  • ArmeoSpring
  • TMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St Mary's Hospital for Children on 2016-09-26.