NCT02309853

Brief Summary

The purpose of this study is to evaluate whether 20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation will be feasible and provide better results compared to 20 Sessions of 30 minutes of a standard visual scanning programme.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

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

November 9, 2014

Completed
22 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 5, 2014

Status Verified

December 1, 2014

Enrollment Period

9 months

First QC Date

November 9, 2014

Last Update Submit

December 4, 2014

Conditions

Outcome Measures

Primary Outcomes (2)

  • Neglect behaviour during activities of daily life measured with the Catherine Bergego Scale

    Measured with the Catherine Bergego Scale

    up to 14 months

  • Adherence rate of the patients to the treatment

    up to 11 months

Secondary Outcomes (9)

  • Visual neglect measured with the Behavioural Inattention Test (conventional subtest)

    up to 14 months

  • Severity of disability in a rehabilitation setting measured with the Functional Independence Measure

    up to 11 months

  • Personal neglect measured with the Vest Test

    up to 14 months

  • Mobility related disability easured with the Rivermead Mobility Index

    up to 11 months

  • Health related quality of life measured with the EQ-5D

    up to 14 months

  • +4 more secondary outcomes

Study Arms (2)

Visual and tactile scanning training

EXPERIMENTAL

20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space combined with trunk rotation

Other: Visual and tactile scanning training

Unimodal visual scanning training

ACTIVE COMPARATOR

20 sessions of 30 minutes with traditional uni-modal visual scanning training

Other: Uni-modal visual scanning training

Interventions

20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space and trunk rotation. The intervention includes visual or tactile scanning training in three different spaces and will be individually adapted to the needs of the patients. 1. Visual or tactile scanning in the personal space 2. Visual or tactile scanning and trunk rotation in the peripersonal space 3. Visual scanning and trunk rotation in the extrapersonal space

Visual and tactile scanning training

20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.

Unimodal visual scanning training

Eligibility Criteria

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

You may qualify if:

  • First or second time right hemispheric stroke (haemorrhagic or ischaemic, diagnosed with computer tomography or magnetic resonance imaging)
  • Time after last stroke: less than 8 weeks
  • Hemispatial neglect with at least seven points on the Catherine Bergego Scale
  • Right handed

You may not qualify if:

  • Reduced vision after rectification (i.e. corrected vision sufficient to read newspaper-sized print)
  • Mini-Mental State Evaluation Score below 11
  • Not fluently speaking and understanding French or German language in order to understand the tasks and the assessments, as assessed and judged by the medical doctor and the staff.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Berner Klinik Montana

Montana, Valais, 3963, Switzerland

RECRUITING

MeSH Terms

Conditions

Perceptual Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

  • Martin Sattelmayer, MSc, MA

    HES-SO Valais-Wallis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Sattelmayer, MSc, MA

CONTACT

Roger Hilfiker, MPTSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

November 9, 2014

First Posted

December 5, 2014

Study Start

December 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

December 5, 2014

Record last verified: 2014-12

Locations