ArmeoSenso - Reward

NCT02257125 | Terminated

• 1 other identifier: EKNZ (LU) 13079
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 3

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.

Conditions

Stroke

Keywords

rehabilitation; virtual reality; stroke; upper extremity; arm; feedback; reward

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Motivation questionnaire

  Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)

• Wolf Motor Function Test

  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

  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

  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

  Assessed for each training visit (i.e., 15 visits over 3 weeks between day 2 and day 22)

Study Arms (2)

high incentive

EXPERIMENTAL

game version including visual effects and monetary rewards

Behavioral: high incentive

low incentive

ACTIVE COMPARATOR

game version without visual effects or monetary rewards

Behavioral: low incentive

Interventions

high incentive BEHAVIORAL

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.

high incentive

low incentive BEHAVIORAL

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.

low incentive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cereneo AG: lead
• University of Zurich: collaborator

Study Sites (3)

Cereneo, Center For Rehabilitation and Neurology

Vitznau, Canton of Lucerne, 6354, Switzerland

Location

Klinik Adelheid

Unterägeri, Canton of Zug, 6314, Switzerland

Location

Zuercher Reha Zentrum Wald

Wald, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 34937456 DERIVED

• 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.

  PMID: 29197412 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreas Luft, Prof.

  University of Zurich, University Hospital Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 6, 2014
• Study Start: January 27, 2015
• Primary Completion: October 28, 2019
• Study Completion: October 28, 2019
• Last Updated: August 13, 2020

Record last verified: 2020-08

Locations

CH (3)