Clinical trial NCT00719433: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Stroke
Upper Extremity Paresis
Keywords: stroke
chronic
rehabilitation
robot therapy
arm therapy
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Sensory Motor Systems Lab, ETH Zurich
name: Balgrist University Hospital
name: Reha Rheinfelden
name: Zuercher Hoehenklinik Wald
First posted: 2008-07-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl Meyer Assessment Scale
timeFrame: 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 outcomes:
measure: 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.
timeFrame: 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
measure: fMRI
timeFrame: before and after 8 weeks therapy, 2-months follow-up
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Balgrist
state: ZH
Study officials:
affiliation: Sensory Motor Systems Lab, ETH Zürich
name: Robert Riener, Prof.
role: STUDY_DIRECTOR
affiliation: Balgrist University Hospital
name: Armin Curt, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.