Strategies of Therapy With the Exoskeleton Robot ARMin

NCT03100422 | Completed DMC

• 1 other identifier: Multi VIT-ARMin
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment, upper extremity motor function

  impairment based clinical test

  from baseline to day 3 post-training

Secondary Outcomes (6)

• ARMin assessment time

  from baseline to day 3 post-training

• ARMin assessment torques

  from baseline to day 3 post-training

• ARMin assessment positions

  from baseline to day 3 post-training

• Intrinsic Motivation Inventory

  from baseline to day 3 post-training

• Motor Activity Log

  from baseline to day 3 post-training

Study Arms (2)

ARMin

EXPERIMENTAL

Therapy with the arm therapy robot ARMin

Device: ARMin

Arm+ occupational therapy

ACTIVE COMPARATOR

a form of conventional occupational therapy that involves both arms

Other: Occupational Therapy

Interventions

ARMin DEVICE

arm therapy robot

ARMin

Occupational Therapy OTHER

bilateral arm training

Arm+ occupational therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

Sponsors & Collaborators

• Swiss Federal Institute of Technology: lead
• Rehaklinik Zihlschlacht AG: collaborator

Study Sites (1)

Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus

Zurich, 8002, Switzerland

Location

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Robert Riener, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Lots will be drawn that assign to either robotic therapy or occupational therapy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: April 4, 2017
• Study Start: May 1, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: July 17, 2020

Record last verified: 2020-07

Locations

CH (1)