StrokeNCT02098135
ArmeoSenso - Home Therapy and Assessment for Patients With Arm Impairments Based on Wearable Movement Sensors
A study testing ArmeoSenso in people with Stroke and Spinal Cord Injury, run by University of Zurich at 1 site in Switzerland.
Trial summary
stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor, Trial with medical device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Spinal Cord Injury
- What is being tested?
- ArmeoSenso
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Sep 2015
- 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
- 18 years old
- Stroke or spinal cord injury in prehistory
- Motor deficits of the upper limb (s)
- Lifting the paretic arm against gravity possible AND
- Minimum amount of movement in the horizontal plane of 20 x 20 cm
- Ability and willingness to participate in the study
Who cannot join
- Severe aphasia
- Severe dementia
- Severe depression
- Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Divison of Neurology
Zurich, Canton of Zurich, 8091
About this study
Official title: Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments
stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,
- Trial with medical device
- Conditions
- Stroke, Spinal Cord Injury
- Being tested
- ArmeoSenso
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArmeoSensoDevice
Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.
| Study group | Role | What they receive |
|---|---|---|
| ArmeoSenso | Experimental | The ArmeoSenso system is an easy to set up and use upper limb rehabilitation system for the home environment. It consists of a motion capture system based on wearable sensors in combination with a personal computer as well as a therapy software that provides an ergonomic user interface, therapy games and automated assessments. Receives: Device: ArmeoSenso |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participant which can perform the ArmeoSenso - training.
Measured: 42 days
Secondary outcomes (1)
Improvement in the Arm function
WMFT (Wolf Motor Function Test), FMA-UL (Fugl-Meyer Assessment - Upper Limb), GRASSP (Graded and Redefined Assessment of Strength, Sensibility and Prehension)
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionNov 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Luft, Prof MD, Principal investigator, University Hospital Zurich, Division of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098135
- Sponsor's protocol ID
- 2013-0182
- Status last verified
- Sep 2015
- First submitted
- 6 Mar 2014
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wittmann F, Held JP, Lambercy O, Starkey ML, Curt A, Hover R, Gassert R, Luft AR, Gonzenbach RR. Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system. J Neuroeng Rehabil. 2016 Aug 11;13(1):75. doi: 10.1186/s12984-016-0182-1.
PubMed 27515583
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of a Home Therapy and Assessment for Patients With Arm Impairments
- ClinicalTrials.gov ID
- NCT02098135
- Acronym / sponsor ID
- 2013-0182
- Conditions
- Stroke, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Mar 2014 (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.
stroke, spinal cord injury, rehabilitation, home therapy, upper limb, arm, virtual reality, interia sensor,
- Trial with medical device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ArmeoSenso | Experimental | Device: ArmeoSensoThe ArmeoSenso system is an easy to set up and use upper limb rehabilitation system for the home environment. It consists of a motion capture system based on wearable sensors in combination with a personal computer as well as a therapy software that provides an ergonomic user interface, therapy games and automated assessments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old
- Stroke or spinal cord injury in prehistory
- Motor deficits of the upper limb (s)
- Lifting the paretic arm against gravity possible AND
- Minimum amount of movement in the horizontal plane of 20 x 20 cm
Key exclusion criteria (4 listed)
- Severe aphasia
- Severe dementia
- Severe depression
- Relevant restriction of vision, which can not be compensated by aids (eg hemianopia)
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 |
|---|---|---|
| ArmeoSensoVirtual realty therapy with a touchscreen computer and movement sensors, over 42 days. | Device | ArmeoSenso |
Primary outcome
Numbers of participant which can perform the ArmeoSenso - training.
Time frame: 42 days
1 secondary outcome
Improvement in the Arm function
Time frame: 42 days
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 15 Sep 2015.
- Derived from this study: PubMed 27515583Wittmann F, Held JP, Lambercy O, Starkey ML, Curt A, Hover R, Gassert R, Luft AR, Gonzenbach RR. Self-directed arm therapy at home after stroke with a sensor-based virtual reality training system. J Neuroeng Rehabil. 2016 Aug 11;13(1):75. doi: 10.1186/s12984-016-0182-1.
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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.
Andreas Luft, Prof MD principal investigator
University Hospital Zurich, Division of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ArmeoSenso in people with Stroke and Spinal Cord Injury, 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 6 inclusion and 4 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 15 Sep 2015. 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?
Numbers of participant which can perform the ArmeoSenso - training. (time frame: 42 days). 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 NCT02098135, which also lists 1 linked publication.
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 15 Sep 2015.