Testing a new robotic therapy for children's arm rehabilitation
Feasibility of a New Pediatric Arm Rehabilitation Robot ChARMin: A Monocentric Interventional Study
This study is testing a new robot therapy to see if it can help children with neurological conditions improve the use of their arms during rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 430 (estimated) |
| Ages | 5 Years to 21 Years |
| Sex | All |
| Sponsor | University Children's Hospital, Zurich Academic / other |
| Locations | 1 site (Affoltern am Albis) |
| Trial ID | NCT02443857 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of a newly developed robotic platform called ChARMin, designed specifically for upper extremity therapy in children with neurological conditions. The research aims to assess the technical and patient-related aspects of using this robot in neurorehabilitation settings. By evaluating its applicability and operability, the study seeks to determine how effectively ChARMin can assist children and adolescents in improving their upper limb function. The study will involve multiple assessments to ensure the robot meets the needs of its young users.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents aged 5 to 21 years with neurological diagnoses and upper extremity impairments.
Not a fit: Patients with severe obesity, fixed contractures, or other specific conditions that prevent safe use of the robot will not benefit from this study.
Why it matters
Potential benefit: If successful, this robotic therapy could significantly enhance rehabilitation outcomes for children with impaired upper extremity function.
How similar studies have performed: Previous studies with similar robotic rehabilitation technologies for adults have shown promising results, suggesting potential for success in this pediatric application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 5 and 21 years * Neurological diagnoses * Impairment of the upper extremity (for projects (i) and (ii) we might also include patients without upper extremity impairments to cover a wide range of patients with different abilities) * Other (non-neurological) diagnoses, who require intense training of the upper extremity Exclusion Criteria: * Strong adipositas, which makes it not possible to adjust the cuffs and orthoses to the anthropometrics of the participant * Fixed contractures of the upper extremity that should be positioned in ChARMin * Instabilities of bones or joints, fractures or osteoporosis/osteopenia * Allergy against material of cuffs * Open skin lesions of the upper extremity that should be positioned in ChARMin * Luxations or subluxations of joints of the upper extremity that should be positioned in ChARMin * Strong pain that increases while training in ChARMin\* * Injuries or lesioned nerves of the upper extremity that should be positioned in ChARMin\* * Strong spontaneous movements like ataxia, dyskinesia, myoclonus\* * Instable vital functions like pulmonal or cardiovascular conditions * Implanted pace maker, defibrillator of the heart * Implanted shunt by hydrocephalus\* * Implanted cochlear or baha\* * Uncooperative or aggressive behaviour * Known or suspected non-compliance * Severe cognitive deficits * Inability to signal pain or discomfort * Apraxia\* * Severe visual impairment (inability to see the screen) * Severe spasticity (Ashworth 4) * Severe epilepsy\* * Insufficient head stability * Infections requiring isolation of the patient Contraindications marked with an \* are relative contraindications. Final approval needs to be obtained from the medical doctor.
Where this trial is running
Affoltern am Albis
- Rehabilitation Center for Children and Adolescents of the University Children's Hospital Zurich — Affoltern am Albis, Switzerland (Recruiting)
Study contacts
- Principal investigator: Hubertus JA van Hedel, PhD — Rehabilitation Center for Children and Adolescents of the University Children's Hospital Zurich
- Study coordinator: Hubertus JA van Hedel, PhD
- Email: hubertus.vanhedel@kispi.uzh.ch
- Phone: +41447625291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.