NCT02353962

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
26 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

1.1 years

First QC Date

January 21, 2015

Last Update Submit

February 9, 2017

Conditions

Hemispatial Neglect

Keywords

neglectexergames

Outcome Measures

Primary Outcomes (1)

  • Feasibility of exergames as measured by training diary.

    During the intervention (3 weeks).

    3 weeks

Secondary Outcomes (3)

  • Usability of exergames as measured by questionnaire.

    7-8 weeks

  • Understanding the experience of living with visuospatial neglect as measured by interviews.

    7-8 weeks

  • Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker.

    7-8 weeks

Study Arms (1)

Neglect Exergames

EXPERIMENTAL

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

Interventions

Neglect ExergamesOTHER

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.

Neglect Exergames

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik Bethesda

Tschugg, Canton of Bern, 3233, Switzerland

Location

Zürcher Höhenklinik Wald

Wald, Canton of Zurich, 8639, Switzerland

Location

Related Publications (1)

  • Tobler-Ammann BC, Surer E, Knols RH, Borghese NA, de Bruin ED. User Perspectives on Exergames Designed to Explore the Hemineglected Space for Stroke Patients With Visuospatial Neglect: Usability Study. JMIR Serious Games. 2017 Aug 25;5(3):e18. doi: 10.2196/games.8013.

    PMID: 28842390DERIVED

Related Links

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rudolf Knols, PhD

    University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 3, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

February 1, 2017

Last Updated

February 10, 2017

Record last verified: 2017-02

Locations

CH(2)