NCT00946062

Brief Summary

The purpose of this study is:

  1. 1.to develop a standardised orientation and mobility training (O\&M-training) in the use of an identification/symbol cane by older adults with low vision, and;
  2. 2.to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

November 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

2.7 years

First QC Date

July 23, 2009

Last Update Submit

November 14, 2013

Conditions

Low VisionAged

Keywords

low visionophthalmologyrandomised controlled trialmobilityorientationcaneaged

Outcome Measures

Primary Outcomes (2)

  • activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))

    5 and 17 weeks

  • distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))

    5 and 17 weeks

Secondary Outcomes (7)

  • activities index (Frenchay Activities Index (FAI))

    5 and 17 weeks

  • social support interactions (Social Support List (SSL 12-I))

    5 and 17 weeks

  • health-related quality of life (EuroQol 5D (EQ5D))

    5 and 17 weeks

  • mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))

    5 and 17 weeks

  • feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))

    5 and 17 weeks

  • +2 more secondary outcomes

Study Arms (2)

regular O&M-training

ACTIVE COMPARATOR

orientation and mobility training in use of the identification cane as provided by mobility trainers

Other: orientation and mobility training

standardised O&M-training

EXPERIMENTAL

standardised orientation and mobility training in use of the identification cane as provided by mobility trainers who received instruction in using the standardised protocol

Other: orientation and mobility training

Interventions

orientation and mobility trainingOTHER

orientation and mobility training

regular O&M-trainingstandardised O&M-training

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 55 years or over
  • Low vision
  • Living independently in the community or in a home for older people
  • Able to see large obstacles and to go outside for a short walk or doing groceries
  • One of the following:
  • experiencing difficulties with safely crossing a street
  • experiencing difficulties with recognising acquaintances outdoors
  • willing to become recognisable as being partially sighted by using the identification cane
  • Written informed consent
  • Orientation and Mobility training (O\&M-training) in the use of an identification cane

You may not qualify if:

  • Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
  • Language or hearing problems that impede completing an interview by telephone
  • Confinement to bed or possible nursing home admission that impede completion of the O\&M-training
  • Permanent use of a walking aid incompatible with the use of an identification cane
  • Having recently received an O\&M-training in the use of an identification cane and permanent use of this cane

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sensis

Grave, Netherlands

Location

Royal Visio

Huizen, Netherlands

Location

Bartimeus

Utrecht, Netherlands

Location

Related Publications (2)

  • Ballemans J, Zijlstra GA, van Rens GH, Schouten JS, Kempen GI. Usefulness and acceptability of a standardised orientation and mobility training for partially-sighted older adults using an identification cane. BMC Health Serv Res. 2012 Jun 8;12:141. doi: 10.1186/1472-6963-12-141.

    PMID: 22681932DERIVED

  • Zijlstra GA, van Rens GH, Scherder EJ, Brouwer DM, van der Velde J, Verstraten PF, Kempen GI. Effects and feasibility of a standardised orientation and mobility training in using an identification cane for older adults with low vision: design of a randomised controlled trial. BMC Health Serv Res. 2009 Aug 27;9:153. doi: 10.1186/1472-6963-9-153.

    PMID: 19712448DERIVED

MeSH Terms

Conditions

Vision, LowOrientation, Spatial

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpatial BehaviorBehavior

Study Officials

  • G.I.J.M. Kempen, PhD

    Maastricht University, CAPHRI School for Public Health and Primary Care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 24, 2009

Study Start

November 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

NL(3)