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Clinical Trials/NCT02353962
NCT02353962CompletedNot Applicable

Evaluating the Feasibility and Usability of Exergames on Exploring the Hemineglected Space in Stroke Patients With Visuo-spatial Neglect

University of Zurich2 sites in 1 country7 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
7
Locations
2
Primary Endpoint
Feasibility of exergames as measured by training diary.

Study Overview

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.

Detailed Description

Within the REWIRE project, nine exergames have been developed for the treatment of visuospatial neglect after stroke. All the exercises were aimed, according to classical rehabilitation, to drive the patients towards the exploration of the hemi-neglected space. The Gentile's taxonomy has been extended to neglect patients and was used to develop the exergames. Gentile's taxonomy of motor skills allows a simple to complex progression of skills and enables determining progress on an objective basis.

According to these specifications, the exergames targeting the exploration of space with additional cognitive and memory tasks with increasing difficulty levels have been developed. This allows an individual game selection suitable for the neglect patient's cognitive skills and guarantees a constant learning process.

The assessments and the virtual-reality based neglect training intervention for the stroke patients will take place at the collaborating rehabilitation clinics in Switzerland.

The neglect training is thought to be an additional therapy option to regain functional independence together with the standard rehabilitation program patients are following during their inpatient stay at the clinic. The exergame neglect training intervention is based on the widely accepted motor learning training principles specificity, initial values, overload and progression. Furthermore, the intervention is planned according to the FITT components; these are: Frequency, Intensity, Time and Type of training. The intervention is characterized by the following parameters:

  • Frequency: 5 sessions per week
  • Intensity: individually adjusted by the treating therapist according to the progress of the participating patient
  • Time: 30-45 minutes per training for 3 weeks
  • Type: REWIRE neglect exergames

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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))

Arms & Interventions

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.

Intervention: Neglect Exergames (Other)

Outcomes

Primary Outcomes

Feasibility of exergames as measured by training diary.

Time Frame: 3 weeks

During the intervention (3 weeks).

Secondary Outcomes

  • Understanding the experience of living with visuospatial neglect as measured by interviews.(7-8 weeks)
  • Usability of exergames as measured by questionnaire.(7-8 weeks)
  • Collecting preliminary data for efficacy as measured by the ZüMAX, the NET and the Eye Tribe Tracker.(7-8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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