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

Status unconfirmed · Not applicable

Conditions studied: Cerebral Palsy, Hemiplegia, Upper Extremity Weakness

In brief

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.

Key facts

Study ID

NCT02914925

Run by

St Mary's Hospital for Children

People needed

10

Starts

2016-02-01

Expected to finish

2018-01-01

Last updated by the study team

2016-09-26

Who can join

Age: 7 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• William Watson — Queens, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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