VIT-ARMin Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Healthy Clinical Trial

— VIT-ARMin  

Official title:

Virtual, Intensified and Patient-tailored Robotic Arm Therapy With the Exoskeleton Robot ARMin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02720341
• Other study ID #: VIT-ARMin
• Status: Terminated
• Phase: N/A
• Start date: April 10, 2015
• Est. completion date: July 2020

Study information

• Verified date: October 2020
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 222
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

Device:
• ARMin
single sessions of about one hour each

Locations

Country	Name	City	State
Switzerland	Balgrist Campus	Zürich
Switzerland	Klinik Lengg	Zürich
Switzerland	Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Klinik Lengg, Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intrinsic Motivation Inventory (IMI) questionaire	The IMI is a multidimensional measurement device that assesses participants' interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity, thus yielding six subscale scores	within one day
Secondary	performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (time in msec)	kinematic and kinetic data during motor performance will be recorded	within one day
Secondary	performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot (position in cm)	kinematic and kinetic data during motor performance will be recorded	within one day
Secondary	performance tests (kinematic and kinetic data) in virtual reality on the ARMin robot ( force in Nm)	kinematic and kinetic data during motor performance will be recorded	within one day
Secondary	muscle strength in Nm	muscle strength will be recorded by the device	within one day
Secondary	questionaire on interaction, time and effort	questions rated on a analog scale by the participant regarding the interaction with participants and therapists, the perceived time and the perceived effort	within one day
Secondary	EMG for muscle activity (time and electric potential)	The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles	within one day
Secondary	EMG for muscle activity (time in sec)	The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles	within one day
Secondary	EMG for muscle activity (electric potential in V)	The level of muscular activity will be assessed by surface electromyography (EMG). The EMG device to be employed is a wireless commercially available certified device (Noraxon). EMG activity of different shoulder and elbow muscles will be recorded using surface electrodes to compare muscle activations in different muscles	within one day
Secondary	detection thresholds (time)	Detection thresholds for sensory stimuli will be assessed	within one day
Secondary	detection thresholds (position in cm)	Detection thresholds for sensory stimuli will be assessed	within one day