Text Size

Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Maastricht University Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
ZonMw: The Netherlands Organisation for Health Research and Development
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00946062
First received: July 23, 2009
Last updated: February 22, 2010
Last verified: February 2010
History of Changes
  Purpose

The purpose of this study is:

  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. to evaluate this newly developed standardised O&M-training with respect to effectiveness and feasibility in a randomised controlled trial.

Condition Intervention
Low Vision
Aged
 Other: orientation and mobility training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Orientation and Mobility Training on Mobility, Participation and Quality of Life in Older Adults With Visual Impairments: a Randomised Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • activities index (Frenchay Activities Index (FAI)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • social support interactions (Social Support List (SSL 12-I)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • health-related quality of life (EuroQol 5D (EQ5D)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]
  • concerns about falling (falls efficacy scale international (FES-I)) [ Time Frame: 5 and 17 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: November 2007
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: regular O&M-training
orientation and mobility training in use of the identification cane as provided by mobility trainers
 Other: orientation and mobility training
orientation and mobility training
Experimental: standardised O&M-training
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
orientation and mobility training

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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:

    1. experiencing difficulties with safely crossing a street
    2. experiencing difficulties with recognising acquaintances outdoors
    3. 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00946062

Locations
Netherlands
Sensis
Grave, Netherlands
Royal Visio
Huizen, Netherlands
Bartimeus
Utrecht, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: G.I.J.M. Kempen, PhD Maastricht University, CAPHRI School for Public Health and Primary Care
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: G.I.J.M. Kempen, PhD, Maastricht University, CAPHRI School for Public Health and Primary Care
ClinicalTrials.gov Identifier: NCT00946062     History of Changes
Other Study ID Numbers: MEC 07-3-057.5/pl, ZonMw 94305004
Study First Received: July 23, 2009
Last Updated: February 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
low vision
ophthalmology
randomised controlled trial
mobility
 orientation
cane
aged

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Sensation Disorders
Neurologic Manifestations
 Nervous System Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013