Trial Review

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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
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?
Secondary ID [1] 291569 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gait disorders 302666 0
cognitive impairment 302667 0
falls 302668 0
Condition category
Condition code
Neurological 302182 302182 0 0
Dementias
Neurological 302184 302184 0 0
Neurodegenerative diseases
Injuries and Accidents 302185 302185 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 297634 0
Treatment: Other
Intervention code [2] 297635 0
Prevention
Comparator / control treatment
No control group in this study. This is a pilot study assessing the feasibility and acceptability of a training program.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301609 0
The feasibility and acceptability of the safe transfer program. This is a composite outcome assessed by a questionnaire designed specifically for this study.
Timepoint [1] 301609 0
The questionnaire is to be completed at the end of the intervention period (week 3). .
Secondary outcome [1] 333284 0
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.
Timepoint [1] 333284 0
At baseline (week 0), end of intervention (week 3) and 3 months after the intervention completion.

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.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/04/2017
Actual
12/05/2017
Date of last participant enrolment
Anticipated
31/01/2020
Actual
22/07/2019
Date of last data collection
Anticipated
30/04/2020
Actual
28/10/2019
Sample size
Target
30
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 296059 0
Self funded/Unfunded
Name [1] 296059 0
Ms Weihong Zhang
Country [1] 296059 0
Australia
Funding source category [2] 296086 0
University
Name [2] 296086 0
The University of Sydney, Faculty of Health Sciences
Country [2] 296086 0
Australia
Primary sponsor type
Individual
Name
Weihong Zhang
Address
Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
Country
Australia
Secondary sponsor category [1] 294949 0
University
Name [1] 294949 0
The University of Sydney, Faculty of Health Sciences
Address [1] 294949 0
Faculty of Health Sciences,
The University of Sydney,
75 East Street,
Lidcombe NSW 2141
Country [1] 294949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297315 0
The University of Sydney HREC
Ethics committee address [1] 297315 0
Research Integrity & Ethics Administration
Research Portfolio
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 297315 0
Australia
Date submitted for ethics approval [1] 297315 0
10/02/2017
Approval date [1] 297315 0
28/03/2017
Ethics approval number [1] 297315 0
2017/116

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73678 0
A/Prof Lee-Fay Low
Address 73678 0
Faculty of Health Sciences, University of Sydney
Rm M309B, Lvl 3, Block M,
75 East Street,
Lidcombe, NSW 2141
Country 73678 0
Australia
Phone 73678 0
+61 2 9036 7368
Fax 73678 0
Email 73678 0
[email protected]
Contact person for public queries
Name 73679 0
Weihong Zhang
Address 73679 0
Faculty of Health Sciences, University of Sydney
75 East Street,
Lidcombe, NSW 2141
Country 73679 0
Australia
Phone 73679 0
+61 2 8324 2265
Fax 73679 0
Email 73679 0
[email protected]
Contact person for scientific queries
Name 73680 0
Weihong Zhang
Address 73680 0
Faculty of Health Sciences, University of Sydney
75 East Street,
Lidcombe, NSW 2141
Country 73680 0
Australia
Phone 73680 0
+61 2 8324 2265
Fax 73680 0
Email 73680 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participant's privacy


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.