StrokeNCT02257125
ArmeoSenso - Reward
A study testing high incentive and low incentive in people with Stroke, run by Cereneo AG at 3 sites in Switzerland.
Trial summary
This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- high incentive and low incentive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 27 Jan 2015to 28 Oct 2019
- 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
- stroke survivor (max. 100 days post-stroke)
- upper extremity motor deficits
- patient can lift the paretic arm against gravity
- patient can move the hand at least 20x20 cm in a horizontal plane
- patient is able and willing to participate
- patient has signed informed consent
Who cannot join
- severe aphasia (impairing verbal instructions)
- severe dementia (impairing the capability to understand instructions)
- severe depression (impairing motivation to train)
- relevant (in the judgement of the investigator) impairment of visual perception, (impairing perception of goals and feedback on the computer screen)
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Klinik Adelheid
Unterägeri, Canton of Zug, 6314
Cereneo, Center For Rehabilitation and Neurology
Vitznau, Canton of Lucerne, 6354
Zuercher Reha Zentrum Wald
Wald
About this study
Official title: ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors
This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.
Read the detailed description
Rewards not only increase motivation to train, but have also been shown to influence motor skill learning via activation of dopaminergic brain structures. In goal oriented tasks, receiving information about goal achievement has a rewarding value, which is further increased if performance has monetary consequences. Computer games often strengthen this kind of information by presenting explosions and other salient stimuli when a goal is achieved (e.g. a target has been reached). The current study investigates the outcome of an arm rehabilitation program, based on such a computer game delivered in two versions. Stroke patients are asked to use their impaired arms to perform goal oriented movements. Movements are translated into movements of a virtual arm on a computer screen. Goals are "meteors", threatening to destroy a planet on which they fall, if not caught by the virtual arm. One version of the computer game delivers state of the art graphics including a number of visual effects and, if the planet was protected successfully, information about a monetary reward, whereas the other version of the program delivers schematic graphic objects only. Training time and intensity are kept constant and outcome measures, including standard clinical motor assessments, are compared between the groups.
- Conditions
- Stroke
- Being tested
- high incentive, low incentive
- Keywords
- rehabilitation, virtual reality, stroke, upper extremity, arm, feedback, reward
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high incentiveBehavioural
Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.
low incentiveBehavioural
Subjects are required to use their arms in order to control a virtual "hand" on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards.
| Study group | Role | What they receive |
|---|---|---|
| high incentive | Experimental | game version including visual effects and monetary rewards Receives: Behavioral: high incentive |
| low incentive | Active comparator | game version without visual effects or monetary rewards Receives: Behavioral: low incentive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ArmeoSenso - hand workspace
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
Measured: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.
Secondary outcomes (8)
Motivation questionnaire
Measures motivation to train.
Measured: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Wolf Motor Function Test
Quantifies upper extremity motor ability through timed and functional tasks.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Fugl-Meyer Assessment Upper Extremity
Measures motor impairment.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Box and Blocks Test
Measures gross manual dexterity.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
ArmeoSenso: pointing task
Goal is to reach targets in the transversal plane in front of the subject: number of targets and time.
Measured: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Motor Activity Log 14 (MAL-14)
Self-reported movement ability.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Barthel Index
Measure of independence in daily living.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
NIHSS
Measure of stroke severity.
Measured: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study start27 Jan 2015
- Primary completion28 Oct 2019
- Study completion28 Oct 2019
Why it stopped: Stopped due to futility considerations: Sample size calculations have assumed smaller effect sizes than considered relevant now.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cereneo AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
- Investigators
- Andreas Luft, Prof., Principal investigator, University of Zurich, University Hospital Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257125
- Sponsor's protocol ID
- EKNZ (LU) 13079
- Status last verified
- Aug 2020
- First submitted
- 30 Sep 2014
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Widmer M, Held JPO, Wittmann F, Valladares B, Lambercy O, Sturzenegger C, Palla A, Lutz K, Luft AR. Reward During Arm Training Improves Impairment and Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):140-150. doi: 10.1177/15459683211062898. Epub 2021 Dec 22.
PubMed 34937456Widmer M, Held JP, Wittmann F, Lambercy O, Lutz K, Luft AR. Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):580. doi: 10.1186/s13063-017-2328-2.
PubMed 29197412
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors
- ClinicalTrials.gov ID
- NCT02257125
- Acronym / sponsor ID
- EKNZ (LU) 13079
- Conditions
- Stroke
- Keywords
- rehabilitation, virtual reality, stroke, upper extremity, arm, feedback, reward
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped due to futility considerations: Sample size calculations have assumed smaller effect sizes than considered relevant now.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Cereneo AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Zurich
- Study start
- 27 Jan 2015 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 28 Oct 2019 (actual)
- First posted
- 6 Oct 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.
This study investigates the use of motivating/rewarding features in a computer based arm rehabilitation program. Half of the subjects will take part, besides receiving standard therapy, in a computer based program delivering a game like scenario with visual effects and monetary rewards in case of successful level completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.
Detailed description
Rewards not only increase motivation to train, but have also been shown to influence motor skill learning via activation of dopaminergic brain structures. In goal oriented tasks, receiving information about goal achievement has a rewarding value, which is further increased if performance has monetary consequences. Computer games often strengthen this kind of information by presenting explosions and other salient stimuli when a goal is achieved (e.g. a target has been reached). The current study investigates the outcome of an arm rehabilitation program, based on such a computer game delivered in two versions. Stroke patients are asked to use their impaired arms to perform goal oriented movements. Movements are translated into movements of a virtual arm on a computer screen. Goals are "meteors", threatening to destroy a planet on which they fall, if not caught by the virtual arm. One version of the computer game delivers state of the art graphics including a number of visual effects and, if the planet was protected successfully, information about a monetary reward, whereas the other version of the program delivers schematic graphic objects only. Training time and intensity are kept constant and outcome measures, including standard clinical motor assessments, are compared between the groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high incentive | Experimental | Behavioral: high incentivegame version including visual effects and monetary rewards |
| low incentive | Active comparator | Behavioral: low incentivegame version without visual effects or monetary rewards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- stroke survivor (max. 100 days post-stroke)
- upper extremity motor deficits
- patient can lift the paretic arm against gravity
- patient can move the hand at least 20x20 cm in a horizontal plane
- patient is able and willing to participate
Key exclusion criteria (4 listed)
- severe aphasia (impairing verbal instructions)
- severe dementia (impairing the capability to understand instructions)
- severe depression (impairing motivation to train)
- relevant (in the judgement of the investigator) impairment of visual perception, (impairing perception of goals and feedback on the computer screen)
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 |
|---|---|---|
| high incentiveSubjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards. | Behavioural | high incentive |
| low incentiveSubjects are required to use their arms in order to control a virtual "hand" on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards. | Behavioural | low incentive |
Primary outcome
Change in ArmeoSenso - hand workspace
Time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.
The subject moves the affected arm as far as possible in all directions while sitting in a gaming position. Movement range is recorded.
8 secondary outcomes
Motivation questionnaire
Time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Wolf Motor Function Test
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Fugl-Meyer Assessment Upper Extremity
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Box and Blocks Test
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
ArmeoSenso: pointing task
Time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Motor Activity Log 14 (MAL-14)
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Barthel Index
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
NIHSS
Time frame: Baseline (day 1), post-training (day 23 ± 5 days) and 3 months post-training (day 113 ± 7 days); training lasts for 3 weeks (15 visits, one per workday)
Results and safety
The study was stopped early (reason given: Stopped due to futility considerations: Sample size calculations have assumed smaller effect sizes than considered relevant now.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Derived from this study: PubMed 34937456Widmer M, Held JPO, Wittmann F, Valladares B, Lambercy O, Sturzenegger C, Palla A, Lutz K, Luft AR. Reward During Arm Training Improves Impairment and Activity After Stroke: A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):140-150. doi: 10.1177/15459683211062898. Epub 2021 Dec 22.
- Derived from this study: PubMed 29197412Widmer M, Held JP, Wittmann F, Lambercy O, Lutz K, Luft AR. Does motivation matter in upper-limb rehabilitation after stroke? ArmeoSenso-Reward: study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):580. doi: 10.1186/s13063-017-2328-2.
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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. principal investigator
University of Zurich, University Hospital Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high incentive and low incentive in people with Stroke, run by Cereneo AG at 3 sites 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: stopped early, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 was stopped early (reason given: Stopped due to futility considerations: Sample size calculations have assumed smaller effect sizes than considered relevant now.). Results are not available in the source record.
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?
Change in ArmeoSenso - hand workspace (time frame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22): Main outcome is the change in hand workspace over the training intervention.). 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 NCT02257125, which also lists 2 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 13 Aug 2020.