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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: robot therapy (ARMin); Other: conventional therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • ZH
    • Zürich, ZH, Switzerland, 8008
      • University Hospital Balgrist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 2	Other: conventional therapy; physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
EXPERIMENTAL: 1	Device: robot therapy (ARMin); therapy of the affected arm with a robot for eight weeks, three times weekly for one hour

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fugl Meyer Assessment Scale	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 Measures

Outcome Measure	Measure Description	Time Frame
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.		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
fMRI	in 20 Patients fMRI will be recorded while patients interact with an MR-compatible manipulandum	before and after 8 weeks therapy, 2-months follow-up

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Balgrist University Hospital; Reha Rheinfelden; Zuercher Hoehenklinik Wald; Sensory Motor Systems Lab, ETH Zurich
• Investigators: Study Director: Robert Riener, Prof., Sensory Motor Systems Lab, ETH Zurich; Principal Investigator: Armin Curt, Prof., Balgrist University Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): September 1, 2012

Study Registration Dates

• First Submitted: July 17, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (ESTIMATE): July 21, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): April 22, 2013
• Last Update Submitted That Met QC Criteria: April 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; chronic; robot therapy; arm therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Cholinesterase Inhibitors; Armin
• Other Study ID Numbers: SNF ARMin III -1; SNF 325200-120621; EK-39/2007