None listed
Conditions
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.
Interventions
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-han
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.
Sponsors
Mark Adams
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed