Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000757617
Ethics application status
Approved
Date submitted
8/07/2014
Date registered
17/07/2014
Date last updated
8/01/2020
Date data sharing statement initially provided
8/01/2020
Date results information initially provided
8/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of low impact flooring on walking for people with Parkinson's disease and stroke.
Scientific title
Exploratory study of ease of walking for parkinson's and stroke patients (compared to control patients) on low impact flooring.
Secondary ID [1] 284941 0
Nil
Universal Trial Number (UTN)
U111111585024
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 292423 0
Stroke 292424 0
Walking 292425 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292738 292738 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ease of walking, as assessed by Timed up and Go test (3 metre) (timed, as well as qualitative comments on gait initiation, speed and safety on turning), on 3 different floor surfaces. These include at least 2 low impact flooring systems and 1 control (standard vinyl on subflooring of concrete).
The 3 low impact floor systems to be tested are (1) Smart Cell flooring which is a standard vinyl laid on a low impact subflooring approx 15mm deep (2) Omnisport Excell floor which is 8-10mm thick and has the vinyl combined with the softer subflooring and is laid as one surface (3) Kradal floor tiles which are again a combined product of vinyl fused with with the low impact layer.
Each patient will be observed twice on each floor type
Patients will be Parkinson's patients or stroke patients and a control group of older rehabilitation patients already in hospital, but who do not have Parkinson's or stroke
Intervention code [1] 289776 0
Rehabilitation
Comparator / control treatment
Ease of walking on standard vinyl (5mm) on subflooring of concrete
Control patient group of older inpatients in rehab wards who do not have parkinson's or stroke
Control group
Active

Outcomes
Primary outcome [1] 292590 0
mean 3 metre Timed up and go test (timed) on each floor type
Timepoint [1] 292590 0
at conclusion of the single observation session (ie patient observed walking 6 times on 3 different floors, in one session, and there is no longitudinal followup)
Secondary outcome [1] 309279 0
patient sense of comfort during walking, as assessed by visual analogue scale
Timepoint [1] 309279 0
at end of single observation session (ie patient observed walking 6 times on 3 different floors, in one session, and there is no longitudinal followup)
Secondary outcome [2] 309280 0
Gait speed as timed (in seconds) by blinded observers of video-recording for first 3m walk (from standing to turning point at 3m) of TUG (above)
Timepoint [2] 309280 0
at end of the single observation session (ie patient observed walking 6 times, on 3 different floors, in one session, and there is no longitudinal follow up)
Secondary outcome [3] 309366 0
patient sense of stability during walking, as assessed by visual analogue scale
Timepoint [3] 309366 0
at end of the single observation session (ie patient observed walking 6 times, on 3 different floors, in one session, and there is no longitudinal follow up)
Secondary outcome [4] 309367 0
any comments from patients about difficulty walking on any of the 3 floors (free text)
Timepoint [4] 309367 0
at end of the single observation session (ie patient observed walking 6 times, on 3 different floors, in one session, and there is no longitudinal follow up)
Secondary outcome [5] 309368 0
Gait initiation difficulties judged by blinded assessors using video-recording of TUG test above. Each patient will be judged on scale with (1) no difficulty (2) mild (3) moderate difficulty (4) marked difficulty or could not start
Timepoint [5] 309368 0
at end of the single observation session (ie patient observed walking 6 times, on 3 different floors, in one session, and there is no longitudinal follow up)
Secondary outcome [6] 309369 0
Safety during turning whilst walking- judged by blinded assessors using video-recording of TUG test above. Each patient will be judged on scale with (1) no difficulty turning (2) mild turning difficulty but no risk of falling ,(3) moderate turning difficulty and major risk of falling (4) marked difficulty turning and stumbles or falls
Timepoint [6] 309369 0
at end of the single observation session (ie patient observed walking 6 times, on 3 different floors, in one session, and there is no longitudinal follow up)

Eligibility
Key inclusion criteria
Current inpatients from any of 5 Older Persons health inpatient wards will be recruited aiming to select a convenience sample that includes: Parkinson’s patients (N=20), Stroke patients with either motor deficits such as hemiplegia with foot drop, poor foot clearance or proprioceptive loss (N= 20) and Control group-non stroke and non-Parkinson’s (N=20)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients need be mobile with or without a walking aid (can be with one person assistance) to be included. Those less mobile, such as those requiring 2 people for walking or hoist transfers are excluded, but could be included later when their mobility has improved.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Convenience sample of current inpatients who have either Parkinson's disease or Stroke (both groups postulated to have greater difficulty walking on low impact flooring.
The order of allocation to each floor type will be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation for the order which floor type tested (random number table from statistics book)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Each patient will be video recorded during their walking tests. These will be assessed by at least 2 different observers (unable to be blinded due to floor surfaces appear different)
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Exploratory study only to see whether anecdotal comments about Parkinson's patients on these low impact floors are real or not
Between group (PD vs Stroke vs control) and between floor type (low impact floor 1 vs low impact floor 2 vs control floor) comparisons. Both quantative (timed TUG) and qualitative assessment of gait will be compared.
TUG times will be compared using students T test (if normal) or Non parametric (such as MWU) if not normal distribution.
Visual analague scores for patient subjective views on comfort and stability whilst walking on these floors will be compared with students t-tests or non paramaetric if data not normal distribution

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2014
Actual
30/10/2014
Date of last participant enrolment
Anticipated
30/04/2016
Actual
9/06/2016
Date of last data collection
Anticipated
Actual
9/06/2016
Sample size
Target
60
Accrual to date
Final
37
Recruitment outside Australia
Country [1] 6205 0
New Zealand
State/province [1] 6205 0
Canterbury

Funding & Sponsors
Funding source category [1] 289570 0
Hospital
Name [1] 289570 0
Canterbury District Health Board
Country [1] 289570 0
New Zealand
Primary sponsor type
Individual
Name
Dr Carl Hanger
Address
The Princess Margaret Hospital
Cashmere Road
PO Box 800
Christchurch 8140
Country
New Zealand
Secondary sponsor category [1] 288252 0
None
Name [1] 288252 0
Address [1] 288252 0
Country [1] 288252 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291307 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 291307 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6145

.
Ethics committee country [1] 291307 0
New Zealand
Date submitted for ethics approval [1] 291307 0
03/07/2014
Approval date [1] 291307 0
24/07/2014
Ethics approval number [1] 291307 0
NZ/1/D5D508

Summary
Brief summary
Falls in hospital are common. Between 35-42% of falls cause injuries and 1 – 3% result in a fracture. These fractures are usually hip or pelvis fractures which threaten life and/or independence. Whilst there are some effective fall prevention strategies for falls in hospitals, fall rates and fall related injuries remain high. It is generally not possible to predict which falls or patients will have injurious falls. One approach is to tackle the whole population at risk by using energy absorbing or low impact flooring (LIF) to prevent injury.

One trial to investigate the practical aspects LIF has already been completed and another is ongoing investigating falls and fall related injuries. For both, 3 different LIFs have been laid in one ward at PMH (total of 12 bed spaces) whilst 8 bed spaces have standard vinyl flooring (SF). During the trial, staff noted that 1 Parkinson’s patient appeared to have more gait initiation difficulties on the LIF. Parkinson’s patients often have gait initiation problems. Staff have commented that some other patients were thought to have “sticky feet” on LIF.
Softer surfaces (includes carpets or LIF), could potentially worsen gait in patients with existing poor balance (eg Parkinson’s and stroke patients). Thus the aim of this exploratory study is to examine gait characteristics on LIFs compared to SF in different patient diagnostic groups.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 118 118 0 0
/AnzctrAttachments/366684-Study protocol.docx

Contacts
Principal investigator
Name 49794 0
Dr Hugh Carl Hanger
Address 49794 0
Older Persons Health Specialist Service, Burwood Hospital, Private Bag 4708, Christchurch 8140
Country 49794 0
New Zealand
Phone 49794 0
++64 3 3377701
Fax 49794 0
Email 49794 0
[email protected]
Contact person for public queries
Name 49795 0
Dr Hugh Carl Hanger
Address 49795 0
Older Persons Health Specialist Service, Burwood Hospital, Private Bag 4708, Christchurch 8140
Country 49795 0
New Zealand
Phone 49795 0
++6433377701
Fax 49795 0
Email 49795 0
[email protected]
Contact person for scientific queries
Name 49796 0
Dr Hugh Carl Hanger
Address 49796 0
Older Persons Health Specialist Service Burwood Hospital Private Bag4708, Christchurch 8140
Country 49796 0
New Zealand
Phone 49796 0
++64 3 3377701
Fax 49796 0
Email 49796 0
[email protected]

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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Losco E, Hanger HC, Wilkinson TJ. Ease of walking... [More Details] 366684-(Uploaded-30-12-2019-14-52-25)-Journal results publication.pdf

Documents added automatically
No additional documents have been identified.