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Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

Primary Purpose

Stroke, Upper Extremity Paresis

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
robot therapy (ARMin)
conventional therapy
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, chronic, rehabilitation, robot therapy, arm therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 or more
  • first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
  • stroke more than six months prior to the study
  • termination of conventional therapy and stable recovery stage (outpatients)
  • moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
  • ability to sit in a chair without any additional support and without leaning on the back rest
  • written informed consent signed by the subject (or an authorized representative)

Exclusion Criteria:

  • Excessive spasticity of the affected arm (mAS ≥ 3)
  • any serious medical or psychiatric illness
  • participation in any clinical investigation within 4 weeks prior to the start of this study
  • anticipated need for any major surgery during the study
  • women known to be pregnant or lactating
  • Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
  • shoulder subluxation (palpatory > 2 fingers)
  • diseased or damaged skin at the paralyzed arm
  • inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
  • cyber sickness
  • pace-maker or other implanted electric devices
  • body weight > 120kg
  • serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
  • participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.

Sites / Locations

  • University Hospital Balgrist

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Fugl Meyer Assessment Scale

Secondary Outcome Measures

Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.
fMRI
in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum

Full Information

First Posted
July 17, 2008
Last Updated
April 19, 2013
Sponsor
University of Zurich
Collaborators
Sensory Motor Systems Lab, ETH Zurich, Balgrist University Hospital, Reha Rheinfelden, Zuercher Hoehenklinik Wald
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1. Study Identification

Unique Protocol Identification Number
NCT00719433
Brief Title
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
Official Title
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
Collaborators
Sensory Motor Systems Lab, ETH Zurich, Balgrist University Hospital, Reha Rheinfelden, Zuercher Hoehenklinik Wald

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.
Detailed Description
Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Upper Extremity Paresis
Keywords
stroke, chronic, rehabilitation, robot therapy, arm therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
robot therapy (ARMin)
Intervention Description
therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
Primary Outcome Measure Information:
Title
Fugl Meyer Assessment Scale
Time Frame
four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up
Secondary Outcome Measure Information:
Title
Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.
Time Frame
three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up
Title
fMRI
Description
in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum
Time Frame
before and after 8 weeks therapy, 2-months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or more first-ever stroke (hemorrhagic or ischemic), verified by brain imaging stroke more than six months prior to the study termination of conventional therapy and stable recovery stage (outpatients) moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38) ability to sit in a chair without any additional support and without leaning on the back rest written informed consent signed by the subject (or an authorized representative) Exclusion Criteria: Excessive spasticity of the affected arm (mAS ≥ 3) any serious medical or psychiatric illness participation in any clinical investigation within 4 weeks prior to the start of this study anticipated need for any major surgery during the study women known to be pregnant or lactating Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity shoulder subluxation (palpatory > 2 fingers) diseased or damaged skin at the paralyzed arm inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised cyber sickness pace-maker or other implanted electric devices body weight > 120kg serious cognitive deficits and aphasia preventing the performance of the ARMin treatment participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Riener, Prof.
Organizational Affiliation
Sensory Motor Systems Lab, ETH Zürich
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Armin Curt, Prof.
Organizational Affiliation
Balgrist University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Balgrist
City
Zürich
State/Province
ZH
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17674069
Citation
Nef T, Mihelj M, Riener R. ARMin: a robot for patient-cooperative arm therapy. Med Biol Eng Comput. 2007 Sep;45(9):887-900. doi: 10.1007/s11517-007-0226-6. Epub 2007 Aug 3.
Results Reference
background
PubMed Identifier
27724916
Citation
Valero-Cuevas FJ, Klamroth-Marganska V, Winstein CJ, Riener R. Robot-assisted and conventional therapies produce distinct rehabilitative trends in stroke survivors. J Neuroeng Rehabil. 2016 Oct 11;13(1):92. doi: 10.1186/s12984-016-0199-5. Erratum In: J Neuroeng Rehabil. 2016 Dec 6;13(1):101.
Results Reference
derived
PubMed Identifier
24382580
Citation
Klamroth-Marganska V, Blanco J, Campen K, Curt A, Dietz V, Ettlin T, Felder M, Fellinghauer B, Guidali M, Kollmar A, Luft A, Nef T, Schuster-Amft C, Stahel W, Riener R. Three-dimensional, task-specific robot therapy of the arm after stroke: a multicentre, parallel-group randomised trial. Lancet Neurol. 2014 Feb;13(2):159-66. doi: 10.1016/S1474-4422(13)70305-3. Epub 2013 Dec 30.
Results Reference
derived

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Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy

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