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Trial registered on ANZCTR
Registration number
ACTRN12617000481370
Ethics application status
Approved
Date submitted
30/03/2017
Date registered
3/04/2017
Date last updated
20/03/2020
Date data sharing statement initially provided
10/05/2019
Type of registration
Prospectively registered
Titles & IDs
Public title
A Safe Transfer Program to Improve Gait and Reduce Falls in Cognitively Impaired Older Adults with Higher Level Gait Disorders: A Pilot Study
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Scientific title
Is it feasible to deliver a safe transfer program to improve gait and reduce falls risk in adults 65 years and over with cognitive impairment and high level gait disorders?
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Secondary ID [1]
291569
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Nil Known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
gait disorders
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cognitive impairment
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falls
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Condition category
Condition code
Neurological
302182
302182
0
0
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Dementias
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Neurological
302184
302184
0
0
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Neurodegenerative diseases
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Injuries and Accidents
302185
302185
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The 3 week intervention program uses combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques to improve safety in transfers. A transfer is defined as a person moving from one position to another, such as standing up from a chair, getting in or out of a bed, etc. The intervention will be delivered by a senior occupational therapist with 13 years clinical experience. It starts with more intensive therapy in week 1 (4 sessions, 30 minutes each session) and gradually decreases the intensity in week 2 (2 sessions, 30 minutes each session) and week 3 (1 session, 30 minutes each session). The sessions are one on one and are carried out at participants' home. The therapist demonstrates the transferring task in 3 steps: initiate walking after standing up from a chair, walk 3-metre distance and back, approach the chair and plan sitting. The instruction "take big steady steps" is emphasised at each step by the therapist. Following the demonstration, participants are provided with verbal cues/instructions prior to each step when performing the task to prevent errors (for example, small, shuffling gait) from happening (EL) and the time intervals between transfer practice sessions gradually increase (SP). The transfer training practice will be generalised into real life activities such as getting in/out of bed, getting on/off toilet seat, getting in/out of lounge chair and getting on/off garden chair, in week 2 and week 3 of the program.
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Intervention code [1]
297634
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Treatment: Other
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Intervention code [2]
297635
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Prevention
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Comparator / control treatment
No control group in this study. This is a pilot study assessing the feasibility and acceptability of a training program.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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The feasibility and acceptability of the safe transfer program. This is a composite outcome assessed by a questionnaire designed specifically for this study.
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Assessment method [1]
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Timepoint [1]
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The questionnaire is to be completed at the end of the intervention period (week 3). .
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Secondary outcome [1]
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The potential effectiveness of the program on risk of falls. This is a composite outcome assessed by a Falls Calendar (self report of the number of falls, location and feature of falls) and comparison of 4 quantitative measures: Get Up&Go, 360 degree turn test, TINETTI and FES-I.
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Assessment method [1]
333284
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Timepoint [1]
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At baseline (week 0), end of intervention (week 3) and 3 months after the intervention completion.
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Eligibility
Key inclusion criteria
* Community dwelling adults aged 65 years and over
* History of falls within the last 3 years
* Higher-level gait disorders: characterised by slow gait, postural instability and one of the following styles/patterns of gait:
- Start hesitation
- Shuffling steps with little lifting of the feet
- Shallow and short steps
- Stepping not fluent
- Stepping with various stride length
- Wide base
- Cautious gait
* Able to mobilise with or without walking aid independently
* Cognitive screening:
- All participants will be screened with RUDAS, a score of 18-26/30 is for inclusion.
- If RUDAS score is>=27/30 (normal range), a more sensitive tool MoCA will be used and a score of <26/30 is for inclusion.
* Informed consent obtained from patient or primary carer/person responsible. A person responsible is required if RUDAS is <=20/30.
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Unstable medical conditions
* Impaired ability to engage in intervention: inability to comprehend or follow simple task instructions, acute confusional state (e.g. delirium), active depression or other psychiatric disorders, severe behavioural disturbances
* Gait disorders with known neurological causes, e.g. Parkinson's Disease, cerebellar ataxia, hemiparetic gait, etc.
* Residents at Aged Care facilities who receive high level care
* Cognitively intact patients, i.e. MoCA >=26/30
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
17/04/2017
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Actual
12/05/2017
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Date of last participant enrolment
Anticipated
31/01/2020
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Actual
22/07/2019
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Date of last data collection
Anticipated
30/04/2020
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Actual
28/10/2019
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Sample size
Target
30
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Accrual to date
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Final
15
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Recruitment in Australia
Recruitment state(s)
NSW
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Ms Weihong Zhang
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Address [1]
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Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
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Country [1]
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Australia
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Funding source category [2]
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University
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Name [2]
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The University of Sydney, Faculty of Health Sciences
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Address [2]
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Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
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Country [2]
296086
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Australia
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Primary sponsor type
Individual
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Name
Weihong Zhang
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Address
Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
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Country
Australia
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Secondary sponsor category [1]
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University
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Name [1]
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The University of Sydney, Faculty of Health Sciences
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Address [1]
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Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
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Country [1]
294949
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The University of Sydney HREC
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Ethics committee address [1]
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Research Integrity & Ethics Administration Research Portfolio Level 2, Margaret Telfer Building (K07) The University of Sydney NSW 2006
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Ethics committee country [1]
297315
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Australia
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Date submitted for ethics approval [1]
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10/02/2017
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Approval date [1]
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28/03/2017
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Ethics approval number [1]
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2017/116
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Summary
Brief summary
This research project will investigate the feasibility and acceptability of combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques in a safe transfer program to improve gait and prevent falls in adults aged 65 and over with mild to moderate cognitive impairment and higher level gait disorders. The assessments and intervention will be conducted at participants' home by a senior occupational therapist who is a co-investigator of the study. The 3 week intervention program starts with more intensive therapy in week 1 (4 sessions, 30min each session) and gradually decreases the intensity in week 2 (2 sessions, 30min each session) and week 3 (1 session, 30min each session). Following demonstration of the transferring task by the therapist, participants are provided with verbal cues prior to each step when performing the task (EL) and the time intervals between each session gradually increase (SR). The transfer training practice will be generalised into real life activities in week 2 and week 3 of the program. Follow up assessments at 3 months post intervention will also be conducted at the participants home. This project will form the pilot study for a larger multi-centre clinical trial, which will assess the long-term effect of this novel falls prevention program targeting older adults with cognitive impairment and higher level gait disorders.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Lee-Fay Low
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Address
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Faculty of Health Sciences, University of Sydney
Rm M309B, Lvl 3, Block M,
75 East Street,
Lidcombe, NSW 2141
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Country
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Australia
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Phone
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+61 2 9036 7368
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Fax
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Email
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lee-fay.low@sydney.edu.au
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Contact person for public queries
Name
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Weihong Zhang
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Address
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Faculty of Health Sciences, University of Sydney
75 East Street,
Lidcombe, NSW 2141
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Country
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Australia
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Phone
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+61 2 8324 2265
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Fax
73679
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Email
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wzha6771@uni.sydney.edu.au
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Contact person for scientific queries
Name
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Weihong Zhang
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Address
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Faculty of Health Sciences, University of Sydney
75 East Street,
Lidcombe, NSW 2141
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Country
73680
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Australia
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Phone
73680
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+61 2 8324 2265
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Fax
73680
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Email
73680
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wzha6771@uni.sydney.edu.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
participant's privacy
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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