Feet, Flat, Foot Ankle Injuries, Foot Deformity, Foot Injury, Foot Sprain
Conditions
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.
Interventions
DEVICECAD/CAM insoles
computer-aided-design computer-aided-manufacture (CAD/CAM) insoles
Sponsors
University of Central Lancashire
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 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 | To compare the changes in pain in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 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 | 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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes. |
| Foot Health Status Questionnaire - Foot Health Sub-domain | 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 | 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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes. |
| Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey) | Measured 12 weeks after being fitted with insoles | To compare the patient satisfaction in two groups of participants fitted with custom CAD/CAM insoles manufactured using different foot shape capture methods. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes. |
| Differential Cost Analysis | Costs were calculated per participant from baseline until their completion of the trial at week 12. | A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tertiary Outcome Measure - Hours of Insole Wear Time Per Day | Measured from baseline until completion of the trial at week 12 | Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is \>21 hours per week |
| Tertiary Outcome Measure - Dropout Rate | Measured from baseline to completion of the trial at 12 weeks, for each participant | Dropout rate = n dropout at end of trial |
Countries
United Kingdom
Participant flow
Pre-assignment details
Assessed for eligibility (n=118) Excluded (n=4) * Already has suitable insoles (n=2) * Not suitable for treatment with insoles (n=1) * Declined to participate (n=1)
Participants by arm
| Arm | Count |
|---|---|
| Insoles Manufactured From Foam-box Cast Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles | 57 |
| Insoles Manufactured From Direct 3D Scan Both arms are currently standard treatment within the NHS GGC Orthotic Department. There are no experimental interventions in the study.
CAD/CAM insoles: computer-aided-design computer-aided-manufacture (CAD/CAM) insoles | 57 |
| Total | 114 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Insoles Manufactured From Foam-box Cast | Insoles Manufactured From Direct 3D Scan | Total |
|---|---|---|---|
| Age, Continuous | 50.0 years | 50.0 years | 50.0 years |
| Area of primary musculoskeletal pathology Ankle | 21 Participants | 24 Participants | 45 Participants |
| Area of primary musculoskeletal pathology First ray | 3 Participants | 10 Participants | 13 Participants |
| Area of primary musculoskeletal pathology Forefoot | 17 Participants | 10 Participants | 27 Participants |
| Area of primary musculoskeletal pathology Lower leg | 0 Participants | 1 Participants | 1 Participants |
| Area of primary musculoskeletal pathology Midfoot | 4 Participants | 1 Participants | 5 Participants |
| Area of primary musculoskeletal pathology Plantar heel / plantar fascia | 12 Participants | 11 Participants | 23 Participants |
| Race/Ethnicity, Customized Ethnicity African | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Other (mixed) | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity White | 56 Participants | 56 Participants | 112 Participants |
| Sex: Female, Male Female | 41 Participants | 41 Participants | 82 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 57 |
| other Total, other adverse events | 7 / 57 | 2 / 57 |
| serious Total, serious adverse events | 0 / 57 | 0 / 57 |
Outcome results
Primary
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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 12 weeks following intervention | 78.13 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 8 weeks following intervention | 72.50 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 4 weeks following intervention | 72.50 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | Baseline | 48.13 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | Baseline | 53.75 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 12 weeks following intervention | 78.75 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 4 weeks following intervention | 78.13 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Pain Sub-domain | 8 weeks following intervention | 78.13 units on a scale |
Secondary
Differential Cost Analysis
A differential cost analysis was undertaken. This involved calculating the total cost for each participant using a calculation of transit costs, staff time, and physical resources for each participant throughout their time in the trial.
Time frame: Costs were calculated per participant from baseline until their completion of the trial at week 12.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Insoles Manufactured From Foam-box Cast | Differential Cost Analysis | 55.46 cost in pounds and pence per participant |
| Insoles Manufactured From Direct 3D Scan | Differential Cost Analysis | 44.94 cost in pounds and pence per participant |
Secondary
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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 12 weeks following intervention | 87.50 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 8 weeks following intervention | 75.00 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 4 weeks following intervention | 87.50 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | Baseline | 68.75 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | Baseline | 62.50 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 12 weeks following intervention | 93.75 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 4 weeks following intervention | 87.50 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire (FHSQ) - Function Sub-domain | 8 weeks following intervention | 93.75 units on a scale |
Secondary
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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Time frame: 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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire - Foot Health Sub-domain | 12 weeks following intervention | 60.00 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire - Foot Health Sub-domain | 8 weeks following intervention | 46.25 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire - Foot Health Sub-domain | 4 weeks following intervention | 42.50 units on a scale |
| Insoles Manufactured From Foam-box Cast | Foot Health Status Questionnaire - Foot Health Sub-domain | Baseline | 25.00 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire - Foot Health Sub-domain | Baseline | 42.50 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire - Foot Health Sub-domain | 12 weeks following intervention | 72.50 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire - Foot Health Sub-domain | 4 weeks following intervention | 60.00 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Foot Health Status Questionnaire - Foot Health Sub-domain | 8 weeks following intervention | 72.50 units on a scale |
Secondary
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. Units on a scale. Minimum score is 0, maximum score is 100. Higher scores represent better outcomes.
Time frame: Measured 12 weeks after being fitted with insoles
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Insoles Manufactured From Foam-box Cast | Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey) | 69.48 units on a scale |
| Insoles Manufactured From Direct 3D Scan | Orthotic and Prosthetic User Survey9-12 (Satisfaction With Device Survey) | 76.35 units on a scale |
Other Pre-specified
Tertiary Outcome Measure - Dropout Rate
Dropout rate = n dropout at end of trial
Time frame: Measured from baseline to completion of the trial at 12 weeks, for each participant
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Insoles Manufactured From Foam-box Cast | Tertiary Outcome Measure - Dropout Rate | 2 Participants |
| Insoles Manufactured From Direct 3D Scan | Tertiary Outcome Measure - Dropout Rate | 0 Participants |
Other Pre-specified
Tertiary Outcome Measure - Hours of Insole Wear Time Per Day
Patients will keep a diary of daily wear time in hours, in accordance with prior publications on measuring Orthotic Adherence. The minimum threshold for adherence is \>21 hours per week
Time frame: Measured from baseline until completion of the trial at week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Insoles Manufactured From Foam-box Cast | Tertiary Outcome Measure - Hours of Insole Wear Time Per Day | 5.08 Hours |
| Insoles Manufactured From Direct 3D Scan | Tertiary Outcome Measure - Hours of Insole Wear Time Per Day | 6.09 Hours |