Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000396224
Ethics application status
Approved
Date submitted
8/03/2018
Date registered
19/03/2018
Date last updated
9/10/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Usability study of the AID (Adams Independent Dynamic) Foot Splint in stroke patients
Scientific title
Usability study of the AID (Adams Independent Dynamic) Foot Splint in stroke patients
Secondary ID [1] 294269 0
Canterbury District Health Board Research Office Project ID: RO# 17262
Universal Trial Number (UTN)
U1111-1206-3271
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 306953 0
Foot drop 306957 0
Condition category
Condition code
Stroke 306051 306051 0 0
Ischaemic
Stroke 306052 306052 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 306053 306053 0 0
Physiotherapy
Physical Medicine / Rehabilitation 306147 306147 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project is a usability study for a new ankle foot splint (Adams Independent Dynamic foot splint) for stroke patients with foot drop that can be applied one handed. It will be compared to the most widely used dynamic foot drop splint in our setting (Dictus splint).
The use of ankle foot splints for foot drop is common following stroke but those patients with reduced/ absent arm function struggle putting on the Dictus splint independently. The AID foot splint was designed to be put on one-handed so that patients would be able to be independent with it's application and reduce their falls risk. The usability will study whether this goal has been achieved and whether it is equal to the Dictus splint during walking.
The materials for the study are; (a) an AID foot splint, (b) a Dictus splint, (c) questionnaires for the participants perception of the splint, and (d) printed instructions for applying both splints.
Dictus splint https://www.alliedmedical.co.nz/products/bracing-supports/lower-body/ankle-foot-orthosis-afo/dictus-band-outdoor-use/
Dictus splint instructions https://www.youtube.com/watch?v=oJQ08KRprZs
AID foot splint (link pictures in google drive showing splint only and splint applied) https://drive.google.com/open?id=1TnyS0w6ieuO4fcE_y55C4TucaXtPEmBn
Participants will trial putting on a Dictus splint and then an Adams Independent Dynamic (AID) foot splint one handed. They will be timed doing this and then asked about their experience of putting the splint on (questionnaire with likert scale).
The order in which they trial putting on the splints will be randomised using an online randomisation tool.
Following this, they will perform a timed walking trial in each of the splints and asked about their experience (questionnaire with likert scale) walking with the splint.
The participants will be instructed in how to complete the tests, they will then have one practice followed by the timed trial.
The research team will consist of Physiotherapists with experience in Stroke rehabilitation and Physiotherapy students in their final year of University, who are supervised by a Physiotherapy tutor who has experience in stroke rehabilitation. All members of the research team have been shown how to put on the splints and written instructions will be provided also.
The intervention will be delivered by the research team face to face with each individual patient.
The study will involve a one-time measurement of the time taken to put the splint on, the walking test and the questionnaires regarding the participants opinion of the splints in both these tests. It is envisioned that the study will take between 30 and 45 minutes to complete.
The tests will take place on two inpatient stroke rehabilitation wards at Burwood Hospital, Christchurch.
Intervention code [1] 300560 0
Treatment: Devices
Intervention code [2] 300561 0
Rehabilitation
Comparator / control treatment
The measurements involving the Dictus splint will be the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 305080 0
The time taken to put the AID foot splint on vs. the time taken to put the Dictus splint on independently.
The time will be measured using a stopwatch.
Timepoint [1] 305080 0
The measure will be performed once on admission to the study.
Primary outcome [2] 305081 0
Participants will perform a three metre timed up and go test..
Equipment needed
5. Standard height chair (seat height 46cm)
6. A measuring tape able to measure 3 meters
7. A stopwatch
8. A plastic cone

General information (Podsiadlo and Rishardson, 1991)
1. The participant should sit on a standard armchair, placing their back against the chair and resting their arms on the chair if this is possible.
2. Any assistive device used for walking should be nearby.
3. The participant should walk to a cone that is 3 meters away, turn around at the line, walk back to the chair, and sit down.
4. The test ends when the participant’s buttocks touch the seat.
5. Participants should be instructed to use a comfortable and safe walking speed.
6. A stopwatch should be used to time the test. The participant has one practice of the test and one timed test.

Set-up:
1. Measure and mark a 3 meter walkway. Place a cone at the 3 meter point.
2. Place a standard height chair (seat height 46cm, arm height 67cm) at the beginning of the walkway

Participant Instructions (Podsiadlo and Richardson, 1991)
5. Instruct the participant to sit on the chair and place his/her back against the chair and rest his/her arms on the chair’s arms if possible.
6. The upper extremities should not be on the assistive device (if used for walking), but it should be nearby.
7. Demonstrate the test to the participant.
8. When the participant is ready, say “Go”
9. The stopwatch should start when you say go, and should be stopped when the participant’s buttocks touch the seat again.
Timepoint [2] 305081 0
Once only on admission to the study
Secondary outcome [1] 344114 0
The study questionnaire will ask participants about their experience using the splints during two key tasks; (i) putting the splint on and taking it off, and (ii) walking with the splint.
The response (agree/ disagree ) of the participants to the questions will be graded using a likert scale ranging from strongly agree to strongly disagree.
The study questionnaire has been designed specifically for the current study.
Timepoint [1] 344114 0
Once on admission to the study

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Have suffered a stroke causing weakness on one side of the body
3. Have a functional level where they can dress their lower body without assistance e.g. able to sit and reach down to their feet.
4. Have reduced function in their arm meaning that they need to adopt one-handed dressing strategies
5. Be able to walk 6 metres
6. Able to answer the study questionnaires (English speaking, no aphasia and no important cognitive issues)
Screening of the patients for these issues will be undertaken by the principal investigator by liaising with ward staff regarding the participant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Dependent on others for sitting balance and unable to reach to their feet.
2. Unable to walk the distance needed to complete the testing procedures
3. Severe cognitive or communication difficulties that would mean that the person is unable to participate fully in the study.
4. Participants cannot be recruited from other settings than the two inpatient stroke rehabilitation wards at Burwood Hospital e.g. acute or community settings

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a small scale usability study with an approximate recruitment number of 10 participants. This figure was decided upon after consultation with clinical scientists and experienced researchers.
The timed tests will be compared to assess whether there is a significant difference between the two splints. Statistical significance will be tested in the first instance, with the clinical significance of any differences then being assessed objectively.
SPSS or other similar software will be used for data analysis.
The results of the questionnaires will be collated and feedback from the participants compared.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/04/2018
Actual
3/04/2018
Date of last participant enrolment
Anticipated
Actual
2/10/2018
Date of last data collection
Anticipated
Actual
5/10/2018
Sample size
Target
10
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 9663 0
New Zealand
State/province [1] 9663 0
Canterbury

Funding & Sponsors
Funding source category [1] 298906 0
Government body
Name [1] 298906 0
Canterbury District Health Board
Country [1] 298906 0
New Zealand
Primary sponsor type
Individual
Name
Mark Adams
Address
Burwood Hospital
300 Burwood Rd,
Burwood,
Christchurch 8083
Country
New Zealand
Secondary sponsor category [1] 298120 0
None
Name [1] 298120 0
Address [1] 298120 0
Country [1] 298120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299847 0
Health and Disability Ethics Committees
Ethics committee address [1] 299847 0
Ethics committee country [1] 299847 0
New Zealand
Date submitted for ethics approval [1] 299847 0
08/01/2018
Approval date [1] 299847 0
28/03/2018
Ethics approval number [1] 299847 0
18/STH/12/AM01

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2485 2485 0 0
/AnzctrAttachments/374675-HDEC - Letter - 18STH12 Approved EXP Application.pdf (Ethics approval)
Attachments [2] 2487 2487 0 0
/AnzctrAttachments/374675-Post HDEC with tracked changes AID PICS changes accepted.docx (Participant information/consent)
Attachments [3] 2488 2488 0 0
/AnzctrAttachments/374675-Protocol foot splint_18_STH_12 post HDEC changes accepted.docx (Protocol)
Attachments [4] 2489 2489 0 0
/AnzctrAttachments/374675-Study outcome measures.docx (Supplementary information)
Attachments [5] 2579 2579 0 0
/AnzctrAttachments/374675-HDEC - Letter - 18STH12AM01 Approved Amendment.pdf (Ethics approval)
Attachments [6] 2580 2580 0 0
/AnzctrAttachments/374675-PICS 18_STH_12 - minor changes - tracked.docx (Participant information/consent)
Attachments [7] 2581 2581 0 0
/AnzctrAttachments/374675-Protocol 18_STH_12 - minor changes tracked.docx (Protocol)
Attachments [8] 2582 2582 0 0
/AnzctrAttachments/374675-Study outcome measures - minor changes - tracked.docx (Supplementary information)

Contacts
Principal investigator
Name 81758 0
Mr Mark Adams
Address 81758 0
Burwood Hospital
300 Burwood Rd
Burwood
Christchurch
Country 81758 0
New Zealand
Phone 81758 0
+64211135698
Fax 81758 0
Email 81758 0
[email protected]
Contact person for public queries
Name 81759 0
Mark Adams
Address 81759 0
Burwood Hospital
300 Burwood Rd
Burwood
Christchurch
Country 81759 0
New Zealand
Phone 81759 0
+64211135698
Fax 81759 0
Email 81759 0
[email protected]
Contact person for scientific queries
Name 81760 0
Mark Adams
Address 81760 0
Burwood Hospital
300 Burwood Rd
Burwood
Christchurch
Country 81760 0
New Zealand
Phone 81760 0
+64211135698
Fax 81760 0
Email 81760 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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