StrokePhase 2/3NCT00719433
Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
A Phase 2/3 study testing robot therapy (ARMin) and conventional therapy in people with Stroke and Upper Extremity Paresis, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Upper Extremity Paresis
- What is being tested?
- robot therapy (ARMin) and conventional therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to Sep 2012
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Balgrist
Zurich, Canton of Zurich, 8008
About this study
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.
Read the 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.
- Conditions
- Stroke, Upper Extremity Paresis
- Being tested
- robot therapy (ARMin), conventional therapy
- Keywords
- stroke, chronic, rehabilitation, robot therapy, arm therapy
- Medical subject headings
- Stroke, Paresis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot therapy (ARMin)Device
therapy of the affected arm with a robot for eight weeks, three times weekly for one hour
conventional therapyOther
physical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: robot therapy (ARMin) |
| 2 | Active comparator | Not described Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment Scale
Measured: 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 (2)
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.
Measured: 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
Measured: before and after 8 weeks therapy, 2-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Sensory Motor Systems Lab, ETH Zurich, Balgrist University Hospital, Reha Rheinfelden, Zuercher Hoehenklinik Wald
- Responsible party
- Sponsor
- Investigators
- Robert Riener, Prof., Study director, Sensory Motor Systems Lab, ETH ZürichArmin Curt, Prof., Principal investigator, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719433
- Sponsor's protocol ID
- SNF ARMin III -1
- Other IDs
- SNF 325200-120621, EK-39/2007
- Status last verified
- Apr 2013
- First submitted
- 17 Jul 2008
- Last updated
- 22 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 17674069Valero-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.
PubMed 27724916Klamroth-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.
PubMed 24382580
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
- ClinicalTrials.gov ID
- NCT00719433
- Acronym / sponsor ID
- SNF ARMin III -1
- Conditions
- Stroke, Upper Extremity Paresis
- Keywords
- stroke, chronic, rehabilitation, robot therapy, arm therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Sensory Motor Systems Lab, ETH Zurich, Balgrist University Hospital, Reha Rheinfelden, Zuercher Hoehenklinik Wald
- Study start
- Jul 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: robot therapy (ARMin) |
| 2 | Active comparator | Other: conventional therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot therapy (ARMin)therapy of the affected arm with a robot for eight weeks, three times weekly for one hour | Device | 1 |
| conventional therapyphysical and occupational therapy of the affected arm for eight weeks, three times weekly for one hour | Other | 2 |
Primary outcome
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
2 secondary outcomes
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
fMRI
Time frame: before and after 8 weeks therapy, 2-months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2013.
- Background: PubMed 17674069Nef 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.
- Derived from this study: PubMed 27724916Valero-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.
- Derived from this study: PubMed 24382580Klamroth-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.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Riener, Prof. study director
Sensory Motor Systems Lab, ETH Zürich
Armin Curt, Prof. principal investigator
Balgrist University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing robot therapy (ARMin) and conventional therapy in people with Stroke and Upper Extremity Paresis, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00719433, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2013.