Comparing Clinical Outcomes Using Two Insole Manufacture Techniques

Study Overview
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Brief Summary
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The main purpose of this study is to find out if scanning the foot using a 3D scanner influences the effectiveness of custom made insoles, compared to the more traditional approach of taking a foam-box impression cast of the foot. Both of these methods are currently used as standard care in the NHS Greater Glasgow and Clyde (GGC) Orthotic Department. In this study, insoles will be manufactured either from a direct 3D scan of the foot, or from a foam-box impression cast, and a series of questionnaires will be used to measure any changes in foot pain and foot function. The results from this study will be used to develop an information resource for both patients and Orthotists which will fill gaps in our current knowledge and hopefully guide us further in providing the best possible care for future patients who require insoles.

Detailed Description
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A single centre, double blinded, randomised controlled trial. Interventional, equivalence Trial design. Participants will be asked to attend 2 face-to-face appointments for assessing and fitting of insoles, which is standard practice in the NHS GGC Orthotic Department. Each face-to-face appointment will take approximately 40 minutes. Following the fitting of the insoles, participants will be asked to participate in 3 telephone calls over 12-weeks, during which they will be asked to answer questions from two questionnaires (the Foot Health Status Questionnaire, and the Orthotic and Prosthetic User Survey). Each telephone appointment will take approximately 15 minutes. Once participants receive their insoles, they will also be asked to keep a diary detailing the number of hours that they wore the insoles each day over 12-weeks. This information will be collected by the Orthotist involved with the trial during the telephone review appointments.

Official Title
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Comparing the Effectiveness of Computer-aided-design Computer-aided-manufacture (CAD/CAM) Insoles Manufactured From Foam-box Cast vs Direct Scan on Patient Reported Outcome Measures: A Double-blinded, Randomised Controlled Trial

Conditions
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Foot Injury, Foot Deformity, Foot Sprain, Feet, Flat, Foot Ankle Injuries

Intervention / Treatment
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* Device: CAD/CAM insoles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Are aged 18 years or above Are referred to the NHS GGC Orthotic service requiring a new assessment for insoles are deemed suitable for CAD/CAM insoles as assessed by the PI or Co-I on clinical assessment Are able to commit to five appointments over a 16-week period (two Face-to-Face appointments, three Telephone Appointments) Have suitable own footwear that can accommodate a CAD/CAM insole as assessed by the PI or Co-I, and as per standard practice can wear these for 12-weeks Is willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the trial. An adequate understanding of written and verbal information in English in order to provide informed consent and answer the study questionnaires Exclusion Criteria: Scheduled elective surgery or other procedures which is likely to affect mobility during the trial. Scheduled steroid injection of the foot or ankle up to 3 months prior to joining the trial, or during participation in the trial Age <18 years Adult with Incapacity, under The Adults with Incapacity (Scotland) Act 2000 Participant unable or unwilling to consent Medial longitudinal Arch height of the foot exceeds depth of EVA blank (35mm) Clinical assessment concludes that the participant requires an insole material other than EVA Clinical assessment concludes that the participant does not require or will be unlikely to benefit from CAD/CAM insoles. The participant is unable to commit to the trial conditions. Peripheral Neuropathy present Active foot ulceration present Participant with life expectancy of less than 6 months. Any other significant disease or disorder which, in the opinion of the PI or Co-I, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial. Participants who have participated in another research trial involving an investigational foot orthosis in the past 12 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: insoles manufactured from foam-box cast<br>Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study. | Device: CAD/CAM insoles<br>* computer-aided-design computer-aided-manufacture (CAD/CAM) insoles<br>|
| Active Comparator: insoles manufactured from direct 3D scan<br>Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study. | Device: CAD/CAM insoles<br>* computer-aided-design computer-aided-manufacture (CAD/CAM) insoles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Health Status Questionnaire (FHSQ) - Pain sub-domain | To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods | Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Foot Health Status Questionnaire (FHSQ) - Function sub-domain | To compare the changes in foot function in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods | Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention | 
| Foot Health Status Questionnaire - foot health sub-domain | To compare the changes in foot health in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods | Measured 4 times throughout the 12-week period that the participant is wearing the insoles: Baseline immediately after receiving intervention (insoles). 4 weeks after intervention. 8 weeks after intervention. And 12 weeks after intervention | 
| Orthotic and Prosthetic User Survey9-12 (Satisfaction with device survey) | To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods | Measured 12 weeks after being fitted with insoles | 
| time-in-transit | Measurement of transit times associated with each arm of the trial will be compared. This will be measured in days. Measuring the number of days for each insole to be delivered after foot shape capture. | Measured for each participant, from the day of foot-shape-capture to the time of insoles being delivered to the Glasgow Royal Infirmary, up to 42 days. |