Strategies of Therapy With the Exoskeleton Robot ARMin

Stroke Clinical Trial

— MultiVIT-ARMin  

Official title:

Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100422
• Other study ID #: Multi VIT-ARMin
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: October 31, 2018

Study information

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

Clinical Trial Summary

Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.

Description:

The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Aged =18 years

• Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI)

• Inpatient at Rehaklinik Zihlschlacht, Switzerland

• Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66)

• No excessive spasticity of the affected arm (modified Ashworth Scale mAS =3) as assessed by the physician

• No serious medical or psychiatric disorder as assessed by the physician

• No serious orthopaedic, rheumatologic or other disease restricting movements of the paretic arm as assessed by the physician

• No clinically significant shoulder subluxation (palpation <2 fingers) as assessed by the physician

• No skin ulcerations at the paretic arm as assessed by the physician

• Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised as assessed by the physician

• No history of cyber sickness (e.g., nausea when looking at a screen or playing computer games) as assessed by the physician

• No pacemaker or other implanted electric device as verified by patient record

• Bodyweight <120 kg

• No serious cognitive defects or aphasia preventing effective use of ARMin as assessed by the physician

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• ARMin
arm therapy robot

Other:
• Occupational Therapy
bilateral arm training

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology	Rehaklinik Zihlschlacht AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl Meyer Assessment, upper extremity motor function	impairment based clinical test	from baseline to day 3 post-training
Secondary	ARMin assessment time	time	from baseline to day 3 post-training
Secondary	ARMin assessment torques	torques	from baseline to day 3 post-training
Secondary	ARMin assessment positions	positions	from baseline to day 3 post-training
Secondary	Intrinsic Motivation Inventory	questionnaire	from baseline to day 3 post-training
Secondary	Motor Activity Log	questionnaire	from baseline to day 3 post-training
Secondary	handheld dynamometer	isometric strength	from baseline to day 3 post-training