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Trial registered on ANZCTR


Registration number
ACTRN12610000634077
Ethics application status
Approved
Date submitted
30/07/2010
Date registered
2/08/2010
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Can the Alexander Technique improve balance and mobility in adults over 50 with visual impairments? A randomised controlled trial.
Scientific title
Can the Alexander Technique improve balance and mobility in adults over 50 with visual impairments?: A randomised controlled trial.
Secondary ID [1] 252351 0
Nil
Universal Trial Number (UTN)
Trial acronym
VISIBILITY
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vision Impairment in adults over 50 years 257855 0
Balance in adults over 50 years with vision impairment 257856 0
Mobility in adults over 50 years with vision impairment 257857 0
Falls Risk in adults over 50 years with vision impairment 257858 0
Mood in adults over 50 years with vision impairment 257859 0
Social Participation in adults over 50 years with vision impairment 257860 0
Quality of Life in adults over 50 years with vision impairment 257861 0
Condition category
Condition code
Eye 258020 258020 0 0
Diseases / disorders of the eye
Injuries and Accidents 258021 258021 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 258022 258022 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will be offered one weekly lessons in the Alexander Technique on 12 consecutive weeks. The lessons are ‘hands-on’ guided movement sessions aimed at improving proprioceptive acuity and postural control in everyday activity. Lessons typically last 30-40 minutes as timing varies depending on individual ability and wellbeing.
Intervention code [1] 256909 0
Treatment: Other
Intervention code [2] 256910 0
Rehabilitation
Intervention code [3] 256911 0
Prevention
Comparator / control treatment
Participants in the control group will continue to receive usual care from Guide Dogs NSW/ACT during the 12 week intervention period of the study. Participants access services from Guide Dogs NSW/ACT on a needs driven basis, and are free to contact the organisation at any time for help with their orientation and mobility needs. Services include mobility training and hazard assessment on specific routes, public transport training and the use of canes, dogs and electronic aids.
Control group
Active

Outcomes
Primary outcome [1] 258874 0
Primary Outcome 1: Performance on the "5 Times Sit to Stand" test from the Short Physical Performance Battery
Timepoint [1] 258874 0
at baseline and at 3 months after intervention commences
Primary outcome [2] 258875 0
Primary Outcome 2: Performance on the "Standing Balance" test from the Short Physical performance Battery
Timepoint [2] 258875 0
at baseline and at 3 months after intervention commences
Primary outcome [3] 258876 0
Primary Outcome 3: Performance on the "Timed Walking" test from the Short Physical Performance Battery
Timepoint [3] 258876 0
at baseline and at 3 months after intervention commences
Secondary outcome [1] 265010 0
Secondary Outcome 1: Fall rate with falls calendars
Timepoint [1] 265010 0
Timepoint: monthly for 12 months from randomisation
Secondary outcome [2] 265011 0
Secondary Outcome 2: Fear of falling with Falls Efficacy Scale - International
Timepoint [2] 265011 0
Timepoint: at baseline and at 3 and 12 months after intervention commences
Secondary outcome [3] 265012 0
Secondary Outcome 3: Mood with the Geriatric Depression Scale and the Positive and Negative Affect Scale
Timepoint [3] 265012 0
Timepoint: at baseline and at 3 and 12 months after intervention commences
Secondary outcome [4] 265013 0
Secondary Outcome 4: Quality of Life with the European Quality of Life-5 Dimensions (EQ-5D)
Timepoint [4] 265013 0
Timepoint: at baseline and at 3 and 12 months after intervention commences
Secondary outcome [5] 265014 0
Secondary Outcome 5: Functional Vision with the Perceived Visual Ability Scale and the Impact of Vision Impairment Scale
Timepoint [5] 265014 0
Timepoint: at baseline and at 3 and 12 months after intervention commences
Secondary outcome [6] 265015 0
Secondary Outcome 6: Community Participation with the Keele Assessment of Participation
Timepoint [6] 265015 0
Timepoint: at baseline and at 3 and 12 months after intervention commences
Secondary outcome [7] 265016 0
Secondary Outcome 7: Activity levels using Actigraphy
Timepoint [7] 265016 0
Timepoint: prior to randomisation and 12 months after intervention commences
Secondary outcome [8] 265017 0
Secondary Outcome 8: Gait analysis using GAITrite pressure sensitive mat
Timepoint [8] 265017 0
Timepoint: subgroup prior to randomisation and 12 months after intervention commences
Secondary outcome [9] 295538 0
Performance on the "5 Times Sit to Stand" test from the Short Physical Performance Battery at 12 months
Timepoint [9] 295538 0
12 months after intervention commences
Secondary outcome [10] 295539 0
Performance on the "Standing Balance" test from the Short Physical performance Battery at 12 months
Timepoint [10] 295539 0
12 months after intervention commences
Secondary outcome [11] 295540 0
Performance on the "Timed Walking" test from the Short Physical Performance Battery at 12 months
Timepoint [11] 295540 0
12 months after intervention commences

Eligibility
Key inclusion criteria
To be eligible, participants will:

1. have a vision impairment such that they require services from Guide Dogs NSW/ACT for assistance with independent mobility

2. be resident in Greater Metropolitan Sydney, NSW, Australia
Minimum age
50 Years
Maximum age
90 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinically diagnosed Dementia, or a Short Portable Mental Status Questionnaire score of less than 8

2. Inability to understand conversational English

3. People with severely restricted mobility, those in wheelchairs, or confined to stationary chairs or beds.

4. Those with planned cataract surgery in the following 12 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
120 participants will be recruited into the study in 4 blocks. After informed consent is gained baseline data collection will be carried out by Orientation & Mobility (O&M) Instructors from Guide Dogs NSW/ACT, trained as research assistants by the study team. These research assistants will be involved in later assessments and will remain masked to treatment allocation.

Participants will be sequentially allocated a study ID number by the study coordinator at Guide Dogs NSW/ACT as they are recruited. The study coordinator will be unaware of the allocation schedule, which will be held by the research team at the George Institute. The study coordinator will communicate the ID number, minus any personal details, to the research team at the George Institute, who will refer to a randomisation list to determine allocation.

The Alexander instructor will not be masked to intervention group allocation as the intervention is a physical modality delivered in the participant’s home. However, this individual will not be involved in outcome assessments.

As an additional precaution to reduce the possibility of unmasking of participants to the research assistants, any participants requiring regular services from Guide Dogs NSW/ACT (usual care) will be assigned to O&M instructors other than those involved in the research project. This means that the research assistants will only interact with the participants at data collection points.

The data assessment forms given to the study team will only have the participants initials, date of birth and study ID number , so that those entering the data from the assessment forms will be blinded to allocation status.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence will be generated using on-line software to randomly allocate the intervention balanced for each block of participants.
This is an online service available at http://www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3064 0
2046
Recruitment postcode(s) [2] 3065 0
2035
Recruitment postcode(s) [3] 3066 0
2039
Recruitment postcode(s) [4] 3067 0
2037
Recruitment postcode(s) [5] 3068 0
2020
Recruitment postcode(s) [6] 3069 0
2192
Recruitment postcode(s) [7] 3070 0
2063
Recruitment postcode(s) [8] 3071 0
2074
Recruitment postcode(s) [9] 3072 0
2030
Recruitment postcode(s) [10] 3073 0
2200
Recruitment postcode(s) [11] 3074 0
2032
Recruitment postcode(s) [12] 3075 0
2071
Recruitment postcode(s) [13] 3076 0
2136
Recruitment postcode(s) [14] 3077 0
2196
Recruitment postcode(s) [15] 3078 0
2219
Recruitment postcode(s) [16] 3079 0
2099
Recruitment postcode(s) [17] 3080 0
2027
Recruitment postcode(s) [18] 3081 0
2010
Recruitment postcode(s) [19] 3082 0
2047
Recruitment postcode(s) [20] 3083 0
2197
Recruitment postcode(s) [21] 3084 0
2011
Recruitment postcode(s) [22] 3085 0
2194
Recruitment postcode(s) [23] 3086 0
2212
Recruitment postcode(s) [24] 3087 0
2088
Recruitment postcode(s) [25] 3088 0
2066
Recruitment postcode(s) [26] 3089 0
2095
Recruitment postcode(s) [27] 3090 0
2221
Recruitment postcode(s) [28] 3091 0
2220
Recruitment postcode(s) [29] 3092 0
2134
Recruitment postcode(s) [30] 3093 0
2228
Recruitment postcode(s) [31] 3094 0
2137
Recruitment postcode(s) [32] 3095 0
2199
Recruitment postcode(s) [33] 3096 0
2042
Recruitment postcode(s) [34] 3097 0
2121
Recruitment postcode(s) [35] 3098 0
2060
Recruitment postcode(s) [36] 3099 0
2204
Recruitment postcode(s) [37] 3100 0
2033
Recruitment postcode(s) [38] 3101 0
2111
Recruitment postcode(s) [39] 3102 0
2135
Recruitment postcode(s) [40] 3103 0
2211
Recruitment postcode(s) [41] 3104 0
2076
Recruitment postcode(s) [42] 3105 0
2061
Recruitment postcode(s) [43] 3106 0
2207
Recruitment postcode(s) [44] 3107 0
2195
Recruitment postcode(s) [45] 3108 0
2065
Recruitment postcode(s) [46] 3109 0
2031
Recruitment postcode(s) [47] 3110 0
2057
Recruitment postcode(s) [48] 3111 0
2087
Recruitment postcode(s) [49] 3112 0
2093
Recruitment postcode(s) [50] 3113 0
2229
Recruitment postcode(s) [51] 3114 0
2114

Funding & Sponsors
Funding source category [1] 257364 0
Government body
Name [1] 257364 0
Australian Postgraduate Award
Address [1] 257364 0
Department of Education, Employment and Workplace Relations
16 - 18 Mort St
Canberra ACT 2600
Country [1] 257364 0
Australia
Funding source category [2] 257365 0
Charities/Societies/Foundations
Name [2] 257365 0
Guide Dogs NSW/ACT (substantial 'in-kind' suport)
Address [2] 257365 0
2-4 Thomas Street
Chatswood NSW 2067
Country [2] 257365 0
Australia
Funding source category [3] 257366 0
Charities/Societies/Foundations
Name [3] 257366 0
FM Alexander Trust
Address [3] 257366 0
The Society of Teachers of the Alexander Technique (STAT)
First Floor, Linton House
39-51 Highgate Road
London NW5 1RS
Country [3] 257366 0
United Kingdom
Funding source category [4] 284502 0
Charities/Societies/Foundations
Name [4] 284502 0
Australian Society of Teachers of the Alexander Technique
Address [4] 284502 0
PO Box 405
Beechworth
Victoria 3747
Country [4] 284502 0
Australia
Primary sponsor type
University
Name
The George Institue for Global Health, University of Sydney
Address
Level 7
341 George St
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 256606 0
University
Name [1] 256606 0
Neuroscience Research Australia, University of NSW
Address [1] 256606 0
Hospital Rd
Randwick NSW 2031
Country [1] 256606 0
Australia
Other collaborator category [1] 251409 0
Charities/Societies/Foundations
Name [1] 251409 0
Guide Dogs NSW/ACT
Address [1] 251409 0
2-4 Thomas Street, Chatswood NSW 2067
Country [1] 251409 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259386 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 259386 0
Level 6, Jane Foss Russell Building - G02
City Road - Darlington Campus
The University of Sydney NSW 2006
Ethics committee country [1] 259386 0
Australia
Date submitted for ethics approval [1] 259386 0
Approval date [1] 259386 0
23/07/2010
Ethics approval number [1] 259386 0
12985

Summary
Brief summary
Vision impairment is a growing public health problem in an ageing population, is an independent risk factor for falls, and compounds the effects of other risk factors by reducing mobility and physical fitness. This randomised controlled trial will investigate the effect of the Alexander Technique on balance and mobility in adults over 50 with vision impairments.

120 people over 50 years of age with vision impairments will participate in the trial. Participants will be independently mobile, with conversational English and no marked cognitive impairment. The intervention group will receive 12 home based lessons in the Alexander Technique on a weekly basis, and the control group will receive usual care.
Outcome measures will be collected by assessors masked to group allocation at baseline, and at 3 and 12 months post randomisation. The primary outcome measure will be physical ability using the Short Physical Performance Battery. Secondary outcome measures will be mobility measured with actigraphy and falls measured with 12 monthly calendars. A smaller sub-study will investigate changes in gait patterns. Mood, quality of life, fall-related self-efficacy and functional vision will be measured with a series of validated questionnaires.

If proven effective, the Alexander Technique will provide an additional modality to improve mobility and reduce falls risk in vulnerable adults with vision impairment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31453 0
Address 31453 0
Country 31453 0
Phone 31453 0
Fax 31453 0
Email 31453 0
Contact person for public queries
Name 14700 0
Michael Gleeson
Address 14700 0
The George Institute for Global Health
Level 7
341 George St
Sydney NSW 2000
Country 14700 0
Australia
Phone 14700 0
+61 2 9657 0435
Fax 14700 0
+61 2 9657 0301
Email 14700 0
mgleeson@georgeinstitute.org.au
Contact person for scientific queries
Name 5628 0
Michael Gleeson
Address 5628 0
The George Institute for Global Health
Level 7
341 George St
Sydney NSW 2000
Country 5628 0
Australia
Phone 5628 0
+61 2 9657 0435
Fax 5628 0
+61 2 9657 0301
Email 5628 0
mgleeson@georgeinstitute.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary