Clinical trial NCT02257125: ArmeoSenso - Reward
Official title: ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: rehabilitation
virtual reality
stroke
upper extremity
arm
feedback
reward
Lead sponsor: Cereneo AG
Sponsor class: INDUSTRY
Collaborators: name: University of Zurich
First posted: 2014-10-06
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in ArmeoSenso - hand workspace
timeFrame: 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:
measure: Motivation questionnaire
timeFrame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
measure: Wolf Motor Function Test
timeFrame: 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)
measure: Fugl-Meyer Assessment Upper Extremity
timeFrame: 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)
measure: Box and Blocks Test
timeFrame: 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)
measure: ArmeoSenso: pointing task
timeFrame: Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
measure: Motor Activity Log 14 (MAL-14)
timeFrame: 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)
measure: Barthel Index
timeFrame: 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)
measure: NIHSS
timeFrame: 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)
Other outcomes:
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo, Center For Rehabilitation and Neurology
state: Lucerne
city: Unterägeri
country: Switzerland
facility: Klinik Adelheid
state: Zug
city: Wald
country: Switzerland
facility: Zuercher Reha Zentrum Wald
Study officials:
affiliation: University of Zurich, University Hospital Zurich
name: Andreas Luft, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Widmer 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.