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Search / Trial NCT02443857

Feasibility of a New Pediatric Arm Rehabilitation Robot ChARMin

Launched by HUUB VAN HEDEL · May 11, 2015

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at a new robot called "ChARMin" that helps children with nervous system diseases improve their arm movement. The goal is to see if this robot can be effectively used for therapy in kids who need rehabilitation for their upper arms. The study is currently recruiting participants aged between 5 and 21 years who have neurological conditions or other diagnoses that require intensive upper body training.

To participate, kids should have some impairment in their arm function, but the trial may also include those without upper extremity impairments to gather more data. However, there are some important exclusions; for example, children with certain severe physical issues, like significant joint problems or certain neurological conditions, may not be eligible. Participants can expect to engage in therapy sessions with the robot, which aims to make rehabilitation more effective and enjoyable. Overall, this trial is an exciting opportunity to explore innovative ways to support children's recovery and improve their quality of life.

Gender

ALL

Eligibility 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.

About Huub Van Hedel

Huub van Hedel is a dedicated clinical trial sponsor committed to advancing medical research and improving patient outcomes through innovative studies and rigorous methodologies. With a strong background in clinical development and a focus on ethical practices, Huub van Hedel collaborates with healthcare professionals and research institutions to design and implement trials that address critical health challenges. The organization prioritizes patient safety and scientific integrity, ensuring that all trials are conducted in accordance with regulatory standards and best practices. Through its efforts, Huub van Hedel aims to contribute valuable insights to the medical community and enhance the efficacy of treatments across various therapeutic areas.

Locations

Affoltern Am Albis, , Switzerland

Patients applied

0 patients applied

Trial Officials

Hubertus JA van Hedel, PhD

Principal Investigator

Rehabilitation Center for Children and Adolescents of the University Children's Hospital Zurich

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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