Clinical trial NCT02720341: VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
Official title: Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Spinal Cord Injury
Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: Klinik Lengg, Zurich
First posted: 2016-03-25
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Consideration-of-Concept Trial (stage 1) on robotic therapy of the upper extremity with the ARMin therapy robot in healthy subjects and patients with neurological disease (e.g. stroke, spinal cord injury)

Detailed description: Neurological patients (e.g., after stroke) need long-term neurorehabilitative therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitative training. Investigators aim at developing a unique intensified and patient-tailored robot-aided training strategy of the arm. The exoskeleton robot ARMin will be further developed to adapt software components accordingly. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. It can be intensified by different strategies that will be evaluated alone and in combination. These strategies include:

strength training an error-amplification strategy increased number of repetitions multisensory feedback multiplayer approach

Eligibility criteria: Inclusion Criteria:

healthy or CVA or spinal cord injury

* Aged ≥18 years
* No excessive spasticity of the affected arm (modified Ashworth Scale ≤3)
* No serious medical or psychiatric disorder as assessed by their physician
* No orthopaedic, rheumatological, or other disease restricting movements of the paretic arm
* No shoulder subluxation (palpation \<2 fingers)
* No skin ulcerations at the paretic arm
* Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised
* No cybersickness (e.g., nausea when looking at a screen or playing computer games)
* No pacemaker or other implanted electric devices
* Bodyweight \<120 kg
* No serious cognitive defects or aphasia preventing effective use of ARMin

Exclusion Criteria

- Allergy against alcohol or no agreement for skin shaving

Primary outcomes:
measure: Intrinsic Motivation Inventory (IMI) questionaire
timeFrame: within one day
Secondary outcomes:
measure: performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec)
timeFrame: within one day
measure: performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm)
timeFrame: within one day
measure: performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm)
timeFrame: within one day
measure: muscle strength in Nm
timeFrame: within one day
measure: questionaire on interaction, time and effort
timeFrame: within one day
measure: EMG for muscle activity (time and electric potential)
timeFrame: within one day
measure: EMG for muscle activity (time in sec)
timeFrame: within one day
measure: EMG for muscle activity (electric potential in V)
timeFrame: within one day
measure: detection thresholds (time)
timeFrame: within one day
measure: detection thresholds (position in cm)
timeFrame: within one day
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
city: Zürich
country: Switzerland
facility: Balgrist Campus
city: Zürich
country: Switzerland
facility: Klinik Lengg
Study officials:
affiliation: ETH Zurich
name: Robert Riener, PhD
role: STUDY_CHAIR
References:
citation: Just F, Ozen O, Tortora S, Klamroth-Marganska V, Riener R, Rauter G. Human arm weight compensation in rehabilitation robotics: efficacy of three distinct methods. J Neuroeng Rehabil. 2020 Feb 5;17(1):13. doi: 10.1186/s12984-020-0644-3.
citation: Baur K, Speth F, Nagle A, Riener R, Klamroth-Marganska V. Music meets robotics: a prospective randomized study on motivation during robot aided therapy. J Neuroeng Rehabil. 2018 Aug 16;15(1):79. doi: 10.1186/s12984-018-0413-8.