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Trial registered on ANZCTR


Registration number
ACTRN12615001313527
Ethics application status
Approved
Date submitted
27/11/2015
Date registered
1/12/2015
Date last updated
12/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Transfer Training Program to Reduce Falls in Cognitively Impaired Older Adults with Higher Level Gait Disorders: A Pilot Study
Scientific title
Is it feasible to deliver a training program to reduce falls risk in adults 65 years and over with cognitive impairment and high level gait disorders?
Secondary ID [1] 287875 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 296759 0
cognitive impairment 296760 0
gait disorders 296761 0
Condition category
Condition code
Neurological 297112 297112 0 0
Dementias
Injuries and Accidents 297126 297126 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 3 week intervention is a transfer training program using combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques to improve safety in transfers. It starts with more intensive therapy in week 1 (5 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 sessions run by either an occupational therapist or a physiotherapist, either on the ward or at the participant's home. The therapist demonstrates the transferring task in 3 steps: initiate walking after standing up from a chair, walk around an object at 3 metre distance, 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 (small, shuffly gait) from happening and the time intervals between each transfer practice gradually increase. The adherence of intervention will be monitored on the ward and at home by therapist's visits during the intervention period. Follow-up phone calls (every fortnight) will be carried out during the 3 month follow up period to check on any falls that do occur by participant using a Falls Calendar.
Intervention code [1] 293242 0
Treatment: Other
Intervention code [2] 293353 0
Prevention
Comparator / control treatment
No control group. This is a pilot study to assess the feasibility of a training program
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296593 0
The feasibility and acceptability of the transfer training program. This is a composit outcome assessed by a questionnaire designed specifically for this study.
Timepoint [1] 296593 0
The questionnaire is to be completed at the end of the intervention period. At the end of each session, two brief questions are asked to get participant's feedback.
Secondary outcome [1] 318832 0
The potential effectiveness of the program on risk of falls. This is assessed by a Falls Calendar (self-report of number of falls, location and feature of falls), comparison of 3 quantitative measures: timed Up&Go, 360 degree turn test and Icon-FES.
Timepoint [1] 318832 0
baseline, end of intervention and 3 months after the intervention completion

Eligibility
Key inclusion criteria
* age 65 years or over admitted under geriatric medicine at SVH with a variety of medical conditions or community dwelling adults aged 65 years and over who are managed by the SVH Geriatric team
* history of falls within the last 12 months
* higher-level gait disorders: wide-based, short-step, shuffling gait and able to mobilise with or without walking aid independently
* timed Up & Go: equal or less than 30 seconds
* Cognitive screening:
- All participants will be screened with RUDAS, a score of 15-26 out of 30 is for inclusion.
- If RUDAS score is equal to or greater than 27 out of 30 (normal range), a more sensitive tool MoCA will be used and a score of less than 26 out of 30 is for inclusion.
- Participant will need to pass spaced retrieval screen.
* Informed consent obtained from patient or primary carer/person responsible. A person responsible is required if RUDAS is equal or less than 20 out of 30.
Minimum age
65 Years
Maximum age
No limit
Gender
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, that is, MoCA equal or greater than 26 out of 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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
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)
NSW
Recruitment hospital [1] 4728 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 12288 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 292372 0
Charities/Societies/Foundations
Name [1] 292372 0
St Vincent’s Clinic Foundation
Address [1] 292372 0
St Vincent’s Clinic Foundation
Level 4
St Vincent’s Clinic
438 Victoria Street
Darlinghurst NSW 2010
Country [1] 292372 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Hospital, Sydney
Address
390 Victoria Street,
Darlinghurst
NSW 2010
Country
Australia
Secondary sponsor category [1] 291059 0
None
Name [1] 291059 0
Address [1] 291059 0
Country [1] 291059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293846 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 293846 0
St Vincent's Research Office
Level 6, Delacy Building
390 Victoria Street
Darlinghurst
NSW 2010
Ethics committee country [1] 293846 0
Australia
Date submitted for ethics approval [1] 293846 0
Approval date [1] 293846 0
23/09/2015
Ethics approval number [1] 293846 0
HREC/15/SVH/272

Summary
Brief summary
This research project will investigate the feasibility and acceptability of combined Errorless Learning (EL) and Spaced Retrieval (SR) techniques in a 3 week transfer training program to prevent falls in adults aged 65 and over with mild to moderate cognitive impairment and higher level gait disorders. Participants are recruited from those admitted to St Vincent's Hospital (SVH) under the Geriatric team or community dwelling adults aged 65 years and over who are managed by the SVH Geriatric team . The assessments and intervention are conducted by a senior occupational therapist and/or a senior physiotherapist under the supervision of the geriatricians. The intervention is either conducted on the ward or in the participants home. Follow up assessments at 3 months post intervention are conducted by the occupational therapist 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 61498 0
Ms Daena Wilson
Address 61498 0
Department of Occupational Therapy
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 61498 0
Australia
Phone 61498 0
+61 2 83823360
Fax 61498 0
Email 61498 0
daena.wilson@svha.org.au
Contact person for public queries
Name 61499 0
Ms Daena Wilson
Address 61499 0
Department of Occupational Therapy
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 61499 0
Australia
Phone 61499 0
+ 61 2 83823360
Fax 61499 0
Email 61499 0
daena.wilson@svha.org.au
Contact person for scientific queries
Name 61500 0
Ms Daena Wilson
Address 61500 0
Department of Occupational Therapy
St Vincent's Hospital
390 Victoria Street
Darlinghurst
NSW 2010
Country 61500 0
Australia
Phone 61500 0
+61 2 8382 3360
Fax 61500 0
Email 61500 0
daena.wilson@svha.org.au

No data has been provided for results reporting
Summary results
Not applicable