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

Aged Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946062
• Other study ID #: MEC 07-3-057.5/pl
• Secondary ID: ZonMw 94305004
• Status: Completed
• Phase: N/A
• First received: July 23, 2009
• Last updated: November 14, 2013
• Start date: November 2007
• Est. completion date: July 2010

Study information

• Verified date: November 2013
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aged
• Low Vision
• Vision, Low

Intervention

Other:
• orientation and mobility training
orientation and mobility training

Locations

Country	Name	City	State
Netherlands	Sensis	Grave
Netherlands	Royal Visio	Huizen
Netherlands	Bartimeus	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	ZonMw: The Netherlands Organisation for Health Research and Development

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))		5 and 17 weeks	No
Primary	distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))		5 and 17 weeks	No
Secondary	activities index (Frenchay Activities Index (FAI))		5 and 17 weeks	No
Secondary	social support interactions (Social Support List (SSL 12-I))		5 and 17 weeks	No
Secondary	health-related quality of life (EuroQol 5D (EQ5D))		5 and 17 weeks	No
Secondary	mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))		5 and 17 weeks	No
Secondary	feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))		5 and 17 weeks	No
Secondary	symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))		5 and 17 weeks	No
Secondary	concerns about falling (falls efficacy scale international (FES-I))		5 and 17 weeks	No