Clinical trial NCT05444192: Comparing Clinical Outcomes Using Two Insole Manufacture Techniques
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Foot Injury
Foot Deformity
Foot Sprain
Feet, Flat
Foot Ankle Injuries
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Central Lancashire
First posted: 2022-07-05
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain
timeFrame: 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 outcomes:
measure: Foot Health Status Questionnaire (FHSQ) - Function Sub-domain
timeFrame: 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
measure: Foot Health Status Questionnaire - Foot Health Sub-domain
timeFrame: 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
measure: Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey)
timeFrame: Measured 12 weeks after being fitted with insoles
measure: Differential Cost Analysis
timeFrame: Costs were calculated per participant from baseline until their completion of the trial at week 12.
Other outcomes:
measure: Tertiary Outcome Measure - Hours of Insole Wear Time Per Day
timeFrame: Measured from baseline until completion of the trial at week 12
measure: Tertiary Outcome Measure - Dropout Rate
timeFrame: Measured from baseline to completion of the trial at 12 weeks, for each participant
Locations:
city: Glasgow
country: United Kingdom
facility: Orthotics Department, Glasgow Royal Infirmary
Study officials:
affiliation: University of Central Lancashire
name: Graham Chapman
role: PRINCIPAL_INVESTIGATOR
References: