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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]

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

Foot drop

Condition category

Condition code

Stroke

Ischaemic

Stroke

Haemorrhagic

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

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]

Treatment: Devices

Intervention code [2]

Rehabilitation

Comparator / control treatment

The measurements involving the Dictus splint will be the comparator group.

Control group

Active

Outcomes

Primary outcome [1]

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]

The measure will be performed once on admission to the study.

Primary outcome [2]

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]

Once only on admission to the study

Secondary outcome [1]

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]

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?

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Canterbury

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Canterbury District Health Board

Address [1]

32 Oxford Terrace,
Christchurch 8011

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/01/2018

Approval date [1]

28/03/2018

Ethics approval number [1]

18/STH/12/AM01

Summary

Brief summary

Background

Stroke patients can present with weakness on one side of their body. Commonly, their ankle muscles can be weak and they are unable to pick their foot up. This is a tripping hazard and a falls risk. Due to this weakness, they may need assistive devices to help them to walk. 
The Dictus splint is a popular splint to use for this population as it allows the patient to use their available muscle strength during the activity. It consists of a leather strap around the ankle, which is attached to the persons shoe by an elastic band and pins. The splint has small components that often fall off e.g. metal pins. The pins can also cause marking on the person’s foot if they have decreased sensation and this can lead to pressure sores or the person choosing not to use the splint due to pain. Additionally, the splints are difficult to put on, and patients usually need carer assistance to get the splint on. Some patients discontinue use the splint due to these difficulties, leading to an increased falls risk. 

This research study will test a new dynamic foot splint that has been designed to be put on independently by stroke patients who need to use one-handed dressing techniques. The new splint is called the Adams Independent Dynamic (AID) foot splint. It does not have any loose pins and so should be more cost effective as it will not need regular replacement of parts. It has been designed by a Physiotherapist who works predominantly with young stroke patients with the help of an engineer and a equipment manufacturer.
Research aims
1.	To assess whether the AID Foot Splint can be put on and taken off independently, using one hand by stroke patients.
2.	To compare the time taken to take the splint on and off between the AID foot splint and Dictus splints.
3.	To compare the AID Foot Splint with the dictus splint when the participant is walking (timed walking
 test).
4.	To ask for feedback from participants regarding the AID Foot Splint’s ease of use during dressing and walking and compare this with their feedback regarding the dictus splint.

It is hoped that the AID foot splint will be just as good as the Dictus splint when people are walking with it on and that people are able to put it on one handed thus helping them to be independent.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/374675-HDEC - Letter - 18STH12 Approved EXP Application.pdf (Ethics approval)

Attachments [2]

/AnzctrAttachments/374675-Post HDEC with tracked changes AID PICS changes accepted.docx (Participant information/consent)

Attachments [3]

/AnzctrAttachments/374675-Protocol foot splint_18_STH_12 post HDEC changes accepted.docx (Protocol)

Attachments [4]

/AnzctrAttachments/374675-Study outcome measures.docx (Supplementary information)

Attachments [5]

/AnzctrAttachments/374675-HDEC - Letter - 18STH12AM01 Approved Amendment.pdf (Ethics approval)

Attachments [6]

/AnzctrAttachments/374675-PICS 18_STH_12 - minor changes - tracked.docx (Participant information/consent)

Attachments [7]

/AnzctrAttachments/374675-Protocol 18_STH_12 - minor changes tracked.docx (Protocol)

Attachments [8]

/AnzctrAttachments/374675-Study outcome measures - minor changes - tracked.docx (Supplementary information)

Contacts

Principal investigator

Name

Mr Mark Adams

Address

Burwood Hospital
300 Burwood Rd
Burwood
Christchurch

Country

New Zealand

Phone

+64211135698

Fax

mark.adams@cdhb.health.nz

Contact person for public queries

Name

Mark Adams

Address

Burwood Hospital
300 Burwood Rd
Burwood
Christchurch

Country

New Zealand

Phone

+64211135698

Fax

mark.adams@cdhb.health.nz

Contact person for scientific queries

Name

Mark Adams

Address

Burwood Hospital
300 Burwood Rd
Burwood
Christchurch

Country

New Zealand

Phone

+64211135698

Fax

mark.adams@cdhb.health.nz

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

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

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