Low VisionNCT00946062
Evaluation of a Standardised Orientation and Mobility Training in Older Adults With Low Vision
A study testing orientation and mobility training in people with Low Vision and Aged, run by Maastricht University Medical Center at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Low Vision, Aged
- What is being tested?
- orientation and mobility training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 3 sitesNetherlands
- Study dates
- Nov 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
About this study
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
The purpose of this study is:
- 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;
- to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.
- Conditions
- Low Vision, Aged
- Being tested
- orientation and mobility training
- Keywords
- low vision, ophthalmology, randomised controlled trial, mobility, orientation, cane, aged
- Medical subject headings
- Vision, Low, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orientation and mobility trainingOther
orientation and mobility training
| Study group | Role | What they receive |
|---|---|---|
| regular O&M-training | Active comparator | orientation and mobility training in use of the identification cane as provided by mobility trainers Receives: 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 Receives: Other: orientation and mobility training |
What is being measured
The primary outcome is the main question the study is designed to answer.
activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))
Measured: 5 and 17 weeks
distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))
Measured: 5 and 17 weeks
Secondary outcomes (7)
activities index (Frenchay Activities Index (FAI))
Measured: 5 and 17 weeks
social support interactions (Social Support List (SSL 12-I))
Measured: 5 and 17 weeks
health-related quality of life (EuroQol 5D (EQ5D))
Measured: 5 and 17 weeks
mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))
Measured: 5 and 17 weeks
feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))
Measured: 5 and 17 weeks
symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))
Measured: 5 and 17 weeks
concerns about falling (falls efficacy scale international (FES-I))
Measured: 5 and 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startNov 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low VisionStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
- Investigators
- G.I.J.M. Kempen, PhD, Principal investigator, Maastricht University, CAPHRI School for Public Health and Primary Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946062
- Sponsor's protocol ID
- MEC 07-3-057.5/pl
- Other IDs
- ZonMw 94305004
- Status last verified
- Nov 2013
- First submitted
- 23 Jul 2009
- Last updated
- 15 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22681932Zijlstra 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.
PubMed 19712448
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00946062
- Acronym / sponsor ID
- MEC 07-3-057.5/pl
- Conditions
- Low Vision, Aged
- Keywords
- low vision, ophthalmology, randomised controlled trial, mobility, orientation, cane, aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- Nov 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- 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;
- to evaluate this newly developed standardised O\&M-training with respect to effectiveness and feasibility in a randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| regular O&M-training | Active comparator | Other: orientation and mobility trainingorientation and mobility training in use of the identification cane as provided by mobility trainers |
| standardised O&M-training | Experimental | Other: orientation and mobility trainingstandardised orientation and mobility training in use of the identification cane as provided by mobility trainers who received instruction in using the standardised protocol |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| orientation and mobility trainingorientation and mobility training | Other | regular O&M-training, standardised O&M-training |
Primary outcome
activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS))
Time frame: 5 and 17 weeks
distance activities and mobility (subscales of the Visual Functioning Questionnaire (VFQ))
Time frame: 5 and 17 weeks
7 secondary outcomes
activities index (Frenchay Activities Index (FAI))
Time frame: 5 and 17 weeks
social support interactions (Social Support List (SSL 12-I))
Time frame: 5 and 17 weeks
health-related quality of life (EuroQol 5D (EQ5D))
Time frame: 5 and 17 weeks
mental health and dependency (subscale of the Visual Functioning Questionnaire (VFQ))
Time frame: 5 and 17 weeks
feelings of anxiety (anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A))
Time frame: 5 and 17 weeks
symptoms of depression (depression subscale of the Hospital Anxiety and Depression Scale (HADS-D))
Time frame: 5 and 17 weeks
concerns about falling (falls efficacy scale international (FES-I))
Time frame: 5 and 17 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.
- Derived from this study: PubMed 22681932Ballemans 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.
- Derived from this study: PubMed 19712448Zijlstra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
G.I.J.M. Kempen, PhD principal investigator
Maastricht University, CAPHRI School for Public Health and Primary Care
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orientation and mobility training in people with Low Vision and Aged, run by Maastricht University Medical Center at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
activities of daily life (subscale of the Groningen Activity Restriction Scale (GARS)) (time frame: 5 and 17 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00946062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2013.