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

Primary Purpose

Cerebral Palsy, Hemiplegia, Upper Extremity Weakness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ArmeoSpring/CIT
Sponsored by
St Mary's Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring CIT, ArmeoSpring, TMS

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • William WatsonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ArmeoSpring/CIT

Arm Description

Group will receive ArmeoSpring and CIT therapy

Outcomes

Primary Outcome Measures

Change in motor cortical map expansion
Transcranial Magnetic Stimulation (TMS)
Change in hand function
Box and Blocks test
Change in hand function
Jebsen Taylor Hand Function Test
Change in bimanual hand function
Assisting Hand Assessment

Secondary Outcome Measures

Full Information

First Posted
September 21, 2016
Last Updated
September 23, 2016
Sponsor
St Mary's Hospital for Children
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1. Study Identification

Unique Protocol Identification Number
NCT02914925
Brief Title
The Effect of Combined Armeospring and CIT on Neuro-motor and Functional Recovery in Children With Unilateral CP
Official Title
The Effect of Combined Armeospring Pediatric and Constraint Induced Therapy on Neuro-motor and Functional Recovery in Children With Unilateral Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Mary's Hospital for Children

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegia, Upper Extremity Weakness
Keywords
CIT, ArmeoSpring, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ArmeoSpring/CIT
Arm Type
Experimental
Arm Description
Group will receive ArmeoSpring and CIT therapy
Intervention Type
Device
Intervention Name(s)
ArmeoSpring/CIT
Intervention Description
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 Information:
Title
Change in motor cortical map expansion
Description
Transcranial Magnetic Stimulation (TMS)
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
Title
Change in hand function
Description
Box and Blocks test
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
Title
Change in hand function
Description
Jebsen Taylor Hand Function Test
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
Title
Change in bimanual hand function
Description
Assisting Hand Assessment
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
William Watson, Ph.D
Phone
718-281-8868
Email
wwatson@stmaryskids.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Watson, Ph.D
Organizational Affiliation
St Mary's Hospital for Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Swetha Krishnaswamy, MS OTR/L
Organizational Affiliation
St Mary's Hospital for Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
William Watson
City
Queens
State/Province
New York
ZIP/Postal Code
11360
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Watson, Ph.D
Phone
718-281-8868
Email
wwatson@stmaryskids.org
First Name & Middle Initial & Last Name & Degree
William Watson, Ph.D
First Name & Middle Initial & Last Name & Degree
Swetha Krishnaswamy, MS OTR/L
First Name & Middle Initial & Last Name & Degree
Hilary Berlin, MD
First Name & Middle Initial & Last Name & Degree
Dawn Cuglietto, Psy.D

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
10835434
Citation
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.
Results Reference
background
PubMed Identifier
24367726
Citation
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.
Results Reference
background

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

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