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Evaluating the Feasibility and Usability of Exergames in Stroke Patients With Visuo-spatial Neglect

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ClinicalTrials.gov Identifier: NCT02353962
Recruitment Status : Completed
First Posted : February 3, 2015
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
The aim of this study is to evaluate the feasibility and usability of newly developed exergames on exploring the hemineglected space of left neglected stroke patients. Furthermore to understand the experience of living with visuospatial neglect and to explore the users' experiences (patients and clinic staff) with those new exergames.

Condition or disease Intervention/treatment Phase
Hemispatial Neglect Other: Neglect Exergames Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluating the Feasibility and Usability of Exergames on Exploring the Hemineglected Space in Stroke Patients With Visuo-spatial Neglect
Study Start Date : March 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Neglect Exergames
Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. 5 sessions per week, 30-45 minutes per training for 3 weeks, with an intensity individually adjusted by the treating therapist according to the progress of the participating patient.
Other: Neglect Exergames
Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. The intervention duration is three weeks. During this week the patients play daily a half hour on workdays. The treatening therapist will adjust the intensity according to the progress of the patient.



Primary Outcome Measures :
  1. Feasibility of exergames as measured by training diary. [ Time Frame: 3 weeks ]
    During the intervention (3 weeks).


Secondary Outcome Measures :
  1. Usability of exergames as measured by questionnaire. [ Time Frame: 7-8 weeks ]
    Questionnaire: After termination of the intervention (3 weeks)

  2. Understanding the experience of living with visuospatial neglect as measured by interviews. [ Time Frame: 7-8 weeks ]
    Interview: 4 weeks after termination of the intervention (3 weeks) during follow-up.

  3. Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker. [ Time Frame: 7-8 weeks ]
    Pre-, post- and 4 weeks after training intervention (3 weeks).



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with visuo-spatial neglect on the left side resulting from a right hemisphere lesion due to a stroke (as measured by the Catherine Bergego Scale (CBS)
  • Stroke incident between 15 to 180 days at the time point of study inclusion
  • In possession of power of judgement regarding to the participation in the study
  • Ability to sit in a (wheel-)chair with a backrest for 45 minutes maximum
  • Age ≥18 years

Exclusion Criteria:

  • Diagnosis of a brain injury other than stroke
  • Other visuospatial syndromes than neglect (e.g. hemianopsia, Balint-syndrome)
  • Occurrence of severe apraxia (˂ 5 points on the Apraxia Screening Tool of TULIA (AST)) (that makes the use of the platform impossible, e.g. not knowing how to use the Novint Falcon haptic device)
  • Non-controlled medical conditions (chronic pain, drug abuse)
  • Poor vision (that makes the use of the platform impossible, e.g. not being able to see clearly on a distance of 60-65cm (placement of PC screen))

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353962


Locations
Switzerland
Klinik Bethesda
Tschugg, Berne, Switzerland, 3233
Zürcher Höhenklinik Wald
Wald, Zürich, Switzerland, 8639
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Rudolf Knols, PhD University of Zurich

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02353962     History of Changes
Other Study ID Numbers: KEK-2014-0543
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017

Keywords provided by University of Zurich:
neglect
exergames

Additional relevant MeSH terms:
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms