ArmeoSenso - Reward

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02257125
• Other study ID #: EKNZ (LU) 13079
• Status: Terminated
• Phase: N/A
• Start date: January 27, 2015
• Est. completion date: October 28, 2019

Study information

• Verified date: August 2020
• Source: Cereneo AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 completion, while the other half will take part in a similar program without visual effects or the possibility to earn money.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: October 28, 2019
• Est. primary completion date: October 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• high incentive
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 incentive
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.

Locations

Country	Name	City	State
Switzerland	Klinik Adelheid	Unterägeri	Zug
Switzerland	Cereneo, Center For Rehabilitation and Neurology	Vitznau	Lucerne
Switzerland	Zuercher Reha Zentrum Wald	Wald

Sponsors (2)

Lead Sponsor	Collaborator
Cereneo AG	University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Motivation questionnaire	Measures motivation to train.	Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)