NCT05661396

Brief Summary

The growing field of new technologies offers new perspectives for neurorehabilitation. Serious games are a promising solution in the rehabilitation of cognitive impairments, and they may be useful in the rehabilitation of unilateral spatial neglect. The investigators developed a rehabilitation program for visual exploration training with a serious game and investigated its efficiency. Six patients with unilateral spatial neglect after a right hemispheric stroke were recruited. Three patients assigned to the experimental group received both serious game training and conventional rehabilitation, and three assigned to the control group received only conventional rehabilitation. The investigators compared the two groups after rehabilitation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable stroke

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 3, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2017

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

7 months

First QC Date

November 21, 2022

Last Update Submit

December 13, 2022

Conditions

Keywords

serious gamestrokeunilateral spatial neglectrehabilitation

Outcome Measures

Primary Outcomes (1)

  • Bells test

    35 bells are spatially distributed among distractors on sheet of paper (15 on the left side, 5 on the center and 15 on the right side). Subjects have to cancel as many bells as possible. The number of omissions on the left and on the right side is recorded.

    up to 4 weeks

Secondary Outcomes (3)

  • Bisection of lines

    up to 4 weeks

  • Ogden scene copying

    up to 4 weeks

  • Reading task

    up to 4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL
Behavioral: Serious game rehabilitation

Control group

NO INTERVENTION

Interventions

Three patients received therapeutic serious game rehabilitation in addition to conventional rehabilitation. The serious game was proposed to be played three times per week for four weeks, for a total of 12 sessions, with 15 min per session (= 45 minutes per week).

Experimental group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral spatial neglect syndrome
  • Right cerebral lesion

You may not qualify if:

  • Epilepsia
  • General mental deterioration
  • Psychiatric disorder
  • No prior history of neurological disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 22, 2022

Study Start

November 3, 2016

Primary Completion

June 3, 2017

Study Completion

September 6, 2017

Last Updated

December 22, 2022

Record last verified: 2022-12