ArmeoSenso - Reward

Study Overview
=================
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.

Official Title
-----------------
ArmeoSenso - Rewarding vs. Non-rewarding Therapy of Patients With Arm Impairments Based on Wearable Movement Sensors

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: high incentive
* Behavioral: low incentive


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high incentive<br>game version including visual effects and monetary rewards | Behavioral: high incentive<br>* 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.<br>|
| Active Comparator: low incentive<br>game version without visual effects or monetary rewards | Behavioral: low incentive<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation questionnaire | Measures motivation to train. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, stroke, arm, rehabilitation, upper extremity, feedback, reward