Feasibility of a New Pediatric Arm Rehabilitation Robot ChARMin

NCT02443857 | Completed DMC

• 1 other identifier: ChARMin
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the applicability and feasibility of the newly developed robot platform for upper extremity therapy ("ChARMin") in children undergoing neurorehabilitation.

Conditions

Nervous System Diseases

Outcome Measures

Primary Outcomes (7)

• ChARMin-1: Score on the feasibility questionnaire [points]

  The feasibility questionnaire is a self-developed tool, which covers the following areas: * Technical aspects: * Patient-related aspects: * Safety * Interface/Games/Assessments

  Up to 8 weeks

• ChARMin-2: Game Scores [points]

  To calculate the game scores of each game, several kinematic and kinetic measures are recorded and processed during the games (for instance number of collected items)

  up to 24 weeks

• ChARMin-3: Assessment battery integrated into the ChARMin software [points]

  The assessment battery consists of: * Range of motion * Workspace measurement * Quality of movement during targeted movements * Isometric strength measurement * Resistance to passive movement of the arm (stiffness) * Accuracy of performing a circle movement in the frontal plane.

  Up to 24 weeks

• ChARMin-3: Change from baseline of the assessment battery integrated into the ChARMin software [delta points]

  To assess the reliability of the assessment battery. The assessment battery consists of: * Range of motion * Workspace measurement * Quality of movement during targeted movements * Isometric strength measurement * Resistance to passive movement of the arm (stiffness) * Accuracy of performing a circle movement in the frontal plane.

  Twice within 3-7 days

• ChARMin-3: Change from baseline of the assessment battery integrated into the ChARMin software

  To assess the responsiveness of the assessment battery. The assessment battery consists of: * Range of motion * Workspace measurement * Quality of movement during targeted movements * Isometric strength measurement * Resistance to passive movement of the arm (stiffness) * Accuracy of performing a circle movement in the frontal plane.

  At onset and end of the hospital stay, which covers an expected average of 7 weeks

• ChARMin-4 and ChARMin-6: Change from baseline in the Box and Block Test [delta of the number of blocks transferred]

  Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. 150, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The participant is instructed to move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. To administer the test, the examiner is seated opposite the individual in order to observe test performance. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. Patient's hand must cross over the partition in order for a point to be given, and blocks that drop or bounce out of the second compartment onto the floor are still rewarded with a point.

  At onset and end of hospital stay, which covers an expected average of 7 weeks

• ChARMin-5: Game scores [points]

  To calculate the game scores of each game, several kinematic and kinetic measures are recorded and processed during the games (for instance number of collected items)

  up to 24 weeks

Secondary Outcomes (11)

• ChARMin-2: Joint angle measures provided by ChARMin [degrees]

  up to 24 weeks

• ChARMin-2: Force measures provided by ChARMin [Newton]

  up to 24 weeks

• ChARMin-2: Amplitude of muscle activation [microVolt]

  up to 24 weeks

• ChARMin-2: Palmar skin conductance [microVolt]

  up to 24 weeks

• ChARMin-2: Heart rate [beats per minute]

  up to 24 weeks

Study Arms (1)

ChARMin

EXPERIMENTAL

Single-arm only

Device: ChARMin

Interventions

ChARMin DEVICE

The aim is to investigate the applicability (technical aspects, patient-related aspects, operability/handling of the robot, the different control modes of the device, safety and the software interface) of ChARMin.

Also known as: ChARMin-1

ChARMin

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huub van Hedel: lead

Study Sites (1)

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

Affoltern am Albis, 8910, Switzerland

Location

Related Publications (3)

• Graser JV, Prospero L, Liesch M, Keller U, van Hedel HJA. Test-retest reliability of upper limb robotic exoskeleton assessments in children and youths with brain lesions. Sci Rep. 2022 Oct 6;12(1):16685. doi: 10.1038/s41598-022-20588-8.

  PMID: 36202825 DERIVED

• Graser JV, Bastiaenen CHG, Gut A, Keller U, van Hedel HJA. Contextual interference in children with brain lesions: a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame. Pilot Feasibility Stud. 2021 Jun 25;7(1):135. doi: 10.1186/s40814-021-00866-4.

  PMID: 34172085 DERIVED

• Graser JV, Bastiaenen CHG, Keller U, van Hedel HJA. Contextual interference in children with brain lesions: protocol of a pilot study investigating blocked vs. random practice order of an upper limb robotic exergame. Pilot Feasibility Stud. 2020 Oct 15;6:156. doi: 10.1186/s40814-020-00694-y. eCollection 2020.

  PMID: 33072397 DERIVED

MeSH Terms

Conditions

Nervous System Diseases

Study Officials

• Hubertus JA van Hedel, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Research and Therapies Rehabilitation Center for Children and Adolescents

Study Record Dates

• First Submitted: April 16, 2015
• First Posted: May 14, 2015
• Study Start: June 1, 2015
• Primary Completion: June 6, 2024
• Study Completion: May 30, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-04

Locations

CH (1)