StrokeMultiVIT-ARMinNCT03100422
Strategies of Therapy With the Exoskeleton Robot ARMin
A study testing ARMin and Occupational Therapy in people with Stroke, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ARMin and Occupational Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 May 2017to 31 Oct 2018
- Phase
- Interventional
- 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
- - Aged ≥18 years
- Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI)
- Inpatient at Rehaklinik Zihlschlacht, Switzerland
- Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66)
- No excessive spasticity of the affected arm (modified Ashworth Scale mAS ≤3) as assessed by the physician
- No serious medical or psychiatric disorder as assessed by the physician
Show all 14Show fewer
- No serious orthopaedic, rheumatologic or other disease restricting movements of the paretic arm as assessed by the physician
- No clinically significant shoulder subluxation (palpation <2 fingers) as assessed by the physician
- No skin ulcerations at the paretic arm as assessed by the physician
- Ability to communicate effectively with the examiner such that the validity of the patient's data could not be compromised as assessed by the physician
- No history of cyber sickness (e.g., nausea when looking at a screen or playing computer games) as assessed by the physician
- No pacemaker or other implanted electric device as verified by patient record
- Bodyweight <120 kg
- No serious cognitive defects or aphasia preventing effective use of ARMin as assessed by the physician
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Labor für Sensomotorische Systeme, ETH Zürich, Balgrist Campus
Zurich, 8002
About this study
Official title: Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin
Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.
Read the detailed description
The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.
- Conditions
- Stroke
- Being tested
- ARMin, Occupational Therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARMinDevice
arm therapy robot
Occupational TherapyOther
bilateral arm training
| Study group | Role | What they receive |
|---|---|---|
| ARMin | Experimental | Therapy with the arm therapy robot ARMin Receives: Device: ARMin |
| Arm+ occupational therapy | Active comparator | a form of conventional occupational therapy that involves both arms Receives: Other: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl Meyer Assessment, upper extremity motor function
impairment based clinical test
Measured: from baseline to day 3 post-training
Secondary outcomes (6)
ARMin assessment time
time
Measured: from baseline to day 3 post-training
ARMin assessment torques
torques
Measured: from baseline to day 3 post-training
ARMin assessment positions
positions
Measured: from baseline to day 3 post-training
Intrinsic Motivation Inventory
questionnaire
Measured: from baseline to day 3 post-training
Motor Activity Log
questionnaire
Measured: from baseline to day 3 post-training
handheld dynamometer
isometric strength
Measured: from baseline to day 3 post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 May 2017
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Rehaklinik Zihlschlacht AG
- Responsible party
- Sponsor
- Investigators
- Robert Riener, PhD, Principal investigator, ETH Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03100422
- Sponsor's protocol ID
- Multi VIT-ARMin
- Acronym
- MultiVIT-ARMin
- Status last verified
- Jul 2020
- First submitted
- 14 Feb 2017
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strategies of Therapy With the Exoskeleton Robot ARMinMulti VIT-ARMin
- ClinicalTrials.gov ID
- NCT03100422
- Acronym / sponsor ID
- MultiVIT-ARMin / Multi VIT-ARMin
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Rehaklinik Zihlschlacht AG
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
Neurological patients (e.g., after stroke) need long-term neurorehabilitation therapy of the arm with often limited, unsatisfactory outcome. Robots became a promising supplement or even alternative for neurorehabilitation training.
Detailed description
The exoskeleton robot ARMin was further developed and software components adapted accordingly to offer a unique intensified and patient-tailored robot-aided training of the arm. The goal is to enhance treatment efficacy to an extent that the improvement in motor function is meaningful for the individual patient. The study objective is to compare ARMin therapy and a form of conventional occupational therapy that involves both arms regarding change in motor function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized
| Arm | Type | Receives |
|---|---|---|
| ARMin | Experimental | Device: ARMinTherapy with the arm therapy robot ARMin |
| Arm+ occupational therapy | Active comparator | Other: Occupational Therapya form of conventional occupational therapy that involves both arms |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- - Aged ≥18 years
- Ischemic cerebral vascular accident (CVA, stroke) in the sub-acute phase (one to twelve weeks post-stroke) as verified by brain imaging (CT or MRI)
- Inpatient at Rehaklinik Zihlschlacht, Switzerland
- Decreased arm motor function in one arm with a FMA of 8 to 20 points (out of 66)
- No excessive spasticity of the affected arm (modified Ashworth Scale mAS ≤3) as assessed by the physician
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ARMinarm therapy robot | Device | ARMin |
| Occupational Therapybilateral arm training | Other | Arm+ occupational therapy |
Primary outcome
Fugl Meyer Assessment, upper extremity motor function
Time frame: from baseline to day 3 post-training
impairment based clinical test
6 secondary outcomes
ARMin assessment time
Time frame: from baseline to day 3 post-training
ARMin assessment torques
Time frame: from baseline to day 3 post-training
ARMin assessment positions
Time frame: from baseline to day 3 post-training
Intrinsic Motivation Inventory
Time frame: from baseline to day 3 post-training
Motor Activity Log
Time frame: from baseline to day 3 post-training
handheld dynamometer
Time frame: from baseline to day 3 post-training
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 17 Jul 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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, PhD principal investigator
ETH Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARMin and Occupational Therapy in people with Stroke, run by Swiss Federal Institute of Technology 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 14 inclusion and 0 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 17 Jul 2020. 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.
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, upper extremity motor function (time frame: from baseline to day 3 post-training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2020.