Robot-assisted Training in Children With CP

Official title

Robot-assisted Hand Training to Induce Manual Functional Change and Cerebral Neural Plasticity in Children With Cerebral Palsy

Overview

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

Detailed description

This study is designed to test whether robot-assisted hand training with Amadeo improves manual functions and induces cerebral neural plasticity in children with CP. To evaluate the efficacy of the robot-assisted hand training, investigators will measure manual motor and sensory functions with behavioral tasks and assess neural activities in the sensorimotor cortical network with high-density electroencephalography (HD-EEG) and transcranial magnetic stimulation (TMS) one day before, one day after, and two months after the robot-assisted training. The study will provide direct evidence on the effectiveness of the robot-assisted training in recovering of manual functions in children with CP. It will provide detailed insights on potential experience-dependent neuraplastic changes in the brain of children with CP. It has the potential to insight the development of more effective rehabilitation for children with CP and also children with other neurological disorders, like pediatric stroke. It may uncover factors that will be predictive of functional improvements in individual CP patient.

Interventions

• Device Robot (Amadeo)-assisted Training
  Amadeo® is an FDA Class I Exempt hand/finger robot that has the capacity to precisely measure hand/finger functions. To use Amadeo, a participant will be seated in a chair. The height of the robot arm support will be adjusted to achieve a comfortable position for the participant. One of the participant's arms will be will be placed on the robot arm support. Magnetic finger tips will then be attached to fingers and thumb. After this, fingers and thumb will be connected to the robot finger slider

Primary outcome measures

• High Density Electroencephalogram (HD-EEG) [Time frame: Baseline, Day 15, Day 60]
• Transcranial magnetic stimulation (TMS) [Time frame: Baseline, Day 15, Day 60]
• MRI [Time frame: Day 15]
• Pegboard Test [Time frame: Baseline, Day 15, Day 60]
• Assisting Hand Assessment (AHA) [Time frame: Baseline, Day 15, Day 60]
• MACS assessment [Time frame: Baseline, Day 15, Day 60]
• Two Point Discrimination [Time frame: Baseline, Day 15, Day 60]
• Monofilament [Time frame: Baseline, Day 15, Day 60]
• Force [Time frame: Baseline, Day 15, Day 60]
• Range of motion [Time frame: Baseline, Day 15, Day 60]

Eligibility criteria

Inclusion criteria

• An evaluation by a pediatric neurologist, Physical Medicine and Rehabilitation (PMNR) physicians (physiatrists), neonatal developmental specialist, or neonatologist with a diagnosis of CP.
• Classified as high-functioning (I or II) at the Gross Motor Function Classification System (GMFCS)
• Participants in the control group should have no history of neurological disorder or brain injury

Exclusion criteria

• Psychoactive or myorelaxant medication during study procedures
• Genetic syndrome diagnosis
• History of trauma or brain operation
• Inability to sit still
• Metal implants
• Baclofen pump
• Inability or unwillingness of patient or parent/legally authorized representative to give written informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Cook Children's Medical Center — Fort Worth

Publications

• Yeargin-Allsopp M, Van Naarden Braun K, Doernberg NS, Benedict RE, Kirby RS, Durkin MS. Prevalence of cerebral palsy in 8-year-old children in three areas of the United States in 2002: a multisite collaboration. Pediatrics. 2008 Mar;121(3):547-54. doi: 10.1542/peds.2007-1270. PMID 18310204
• Stanley, F. J., Blair, E., & Alberman, E. (2000). Cerebral palsies: epidemiology and causal pathways (No. 151). Cambridge University Press.
• Centers for Disease Control and Prevention (CDC). Economic costs associated with mental retardation, cerebral palsy, hearing loss, and vision impairment--United States, 2003. MMWR Morb Mortal Wkly Rep. 2004 Jan 30;53(3):57-9. PMID 14749614
• Gorin NC, Coiffier B, Hayat M, Fouillard L, Kuentz M, Flesch M, Colombat P, Boivin P, Slavin S, Philip T. Recombinant human granulocyte-macrophage colony-stimulating factor after high-dose chemotherapy and autologous bone marrow transplantation with unpurged and purged marrow in non-Hodgkin's lymphoma: a double-blind placebo-controlled trial. Blood. 1992 Sep 1;80(5):1149-57. PMID 1515637
• Van Heest AE, House J, Putnam M. Sensibility deficiencies in the hands of children with spastic hemiplegia. J Hand Surg Am. 1993 Mar;18(2):278-81. doi: 10.1016/0363-5023(93)90361-6. PMID 8463594
• Cooper J, Majnemer A, Rosenblatt B, Birnbaum R. The determination of sensory deficits in children with hemiplegic cerebral palsy. J Child Neurol. 1995 Jul;10(4):300-9. doi: 10.1177/088307389501000412. PMID 7594266
• Sanger TD, Kukke SN. Abnormalities of tactile sensory function in children with dystonic and diplegic cerebral palsy. J Child Neurol. 2007 Mar;22(3):289-93. doi: 10.1177/0883073807300530. PMID 17621498
• Wingert JR, Burton H, Sinclair RJ, Brunstrom JE, Damiano DL. Joint-position sense and kinesthesia in cerebral palsy. Arch Phys Med Rehabil. 2009 Mar;90(3):447-53. doi: 10.1016/j.apmr.2008.08.217. PMID 19254610

Identifiers

NCT: NCT06450158 · 2021-012 · 1R218D090549-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗