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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719433
• Other study ID #: SNF ARMin III -1
• Secondary ID: SNF 325200-12062
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 17, 2008
• Last updated: April 19, 2013
• Start date: July 2008
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Upper Extremity Paresis

Intervention

Device:
• robot therapy (ARMin)
therapy of the affected arm with a robot for eight weeks, three times weekly for one hour

Other:
• conventional therapy
physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour

Locations

Country	Name	City	State
Switzerland	University Hospital Balgrist	Zürich	ZH

Sponsors (4)

Lead Sponsor	Collaborator
University of Zurich	Reha Rheinfelden, Spinal Cord Injury (SCI) Center, University Hospital Balgrist, Zurich, Zuercher Hoehenklinik Wald

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Nef T, Mihelj M, Riener R. ARMin: a robot for patient-cooperative arm therapy. Med Biol Eng Comput. 2007 Sep;45(9):887-900. Epub 2007 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No

External Links

•   description of arm robot