Strategies of Therapy With the Exoskeleton Robot ARMin | NCT03100422

Studies
Strategies of Therapy With the Exoskeleton Robot ARMin

NCT03100422

Sponsor

Swiss Federal Institute of Technology

Status

Completed

Last Update Posted

Jul 17, 2020Actual

Enrollment

18Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

ARMin
Occupational Therapy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2017Actual

Primary Completion Date

Oct 31, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Feb 14, 2017

First Submission Date that Met QC Criteria

Mar 28, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 15, 2020

Last Update Posted Date

Jul 17, 2020Actual

Name	Class
Rehaklinik Zihlschlacht AG	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
ARMin	Device	arm therapy robot	ARMin
Occupational Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Fugl Meyer Assessment, upper extremity motor function	impairment based clinical test	from baseline to day 3 post-training

Secondary Outcomes

Measure	Description	Time Frame
ARMin assessment time	time	from baseline to day 3 post-training
ARMin assessment torques	torques	from baseline to day 3 post-training

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Robert Riener, PhD	ETH Zurich	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus		Zurich		8002	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care
D005791	Patient Care