Table 2 Characteristics of included studies and overview of FOs characteristics
Author (year) | Study design | Participant description | Intervention | Time | Outcome |
|---|---|---|---|---|---|
Region of interest - forefoot | |||||
Chalmers et al. 2000 [31] | randomized controlled clinical trial with a repeated measures design | number  - n = 28 setting  - occupational therapy department of hospital diagnoses  - definitive diagnosis of RA age (years)  - women: 60 (10)  - men: 63 (2)  mean (SD) clinical characteristics  - subluxed MTP joints  - bilaterally MTP joint pain | Custom-made, semi-rigid (total-contact) FOs  - based on casts taken in a non-weight bearing position  - constructed of semi-rigid material  - addition of forefoot cushioning, and forefoot and hindfoot nickleplast posts target of treatment  - support, stabilisation or correction of foot structures  - cushioning (forefoot) | 12 weeks for each intervention, separated by 2 week washouts | foot pain  - VAS pain   (primary outcome) physical functioning  - 50 ft walking time, s*  - RB*  - TADL patient satisfaction  - VAS treatment effectiveness  - Nomination of the FOs of preference |
Custom-made, soft (impression) FOs  - based on an impression in preheated plastazote during weight-bearing  - constructed of soft materials  - addition of metatarsal lifts target of treatment  - support, stabilisation or correction of foot structures  - cushioning (full length) | |||||
Control intervention  - shoe-only | |||||
Chang et al. 2011 [35] | controlled clinical trial with a repeated measures design (single session) | number  - n = 19 setting  - podiatric outpatient clinic of a hospital diagnoses  - definitive diagnosis of RA age (years)  - 58.6 (10.1)   mean (range) clinical characteristics  - forefoot pain  - toe-deformities and/or hallux valgus | Custom-made, semi-rigid (total-contact) FOs  - based on a foot impression (made in a foot impression box) while holding the subtalar joint at a neutral position  - constructed of semi-rigid materials (cork)  - addition of metatarsal support (cork) and cushioning material (full-length) target of treatment  - support, stabilisation or correction of foot structures  - cushioning, full length  - forefoot plantar pressure reduction | 1 month | foot function  - In-shoe plantar foot pressure (peak pressure, pressure-time integral, mean force contact area)   (primary outcome) foot pain  - VAS pain patient satisfaction  - Nomination of the FOs of preference |
Custom-made, soft (impression) FOs  - based on impression in plastazote during weight-bearing (ADL 2–3 weeks)  - constructed of soft materials  - addition of metatarsal pad and arch support of EVA target of treatment  - support, stabilisation or correction of foot structures  - cushioning, full length  - forefoot plantar pressure reduction | |||||
Control intervention  - 7-mm flat EVA (40 Shore A hardness) FOs | |||||
Gibson et al. 2014 [11] | controlled clinical trial with a repeated measures design (single session) | number  - n = 16 setting  - early arthritis clinic of a hospital diagnoses  - definitive diagnosis of RA, > 2 years previously age (years)  - 50.7 (8.4)   mean (range) clinical characteristics  - acquired and passively correctable pes plano valgus  - with or without forefoot pain at MTP joints  - orthotic naive | Custom-made, semi-rigid (total-contact) FOs  - based on a plaster cast model of the foot using the subtalar joint neutral technique.  - constructed of semi-rigid material (polypropylene)  - optional adaptations (external rearfoot wedge control, arch height, forefoot cushioning) based on an algorithm of design rules. target of treatment  - support, stabilisation or correction of foot structures  - cushioning (forefoot)  - forefoot plantar pressure reduction | 7 days per intervention (without washout- periods) | foot function  - Gait characteristics (rearfoot eversion, ankle internal moment, forefoot dorsiflexion, navicular height)   (primary outcome)  - In-shoe plantar foot pressure (forefoot peak pressure, midfoot contact area pressure-time integral, mean force contact area) (primary outcome) patient satisfaction  - Likert scale (orthotic device comfort, orthotic device fit, self-reported efficacy, symptoms, activity levels)   adverse events  - minor and major |
Custom-made, rigid (total-contact) FOs; CAD design using selective laser sintering  - the CAD design is based on a digitized plaster cast model of the foot using the subtalar joint neutral technique and an algorithm of design rules  - manufactured using selective laser sintering using nylon-12 powder target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Custom-made, semi-rigid (total-contact) FOs; CAD design using fused-deposition method  - the CAD design is based on a digitized plaster cast model of the foot using the subtalar joint neutral technique and an algorithm of design rules  - manufactured using fused-deposition method using polylactide target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Control intervention  - shoe-only | |||||
Hodge et al. 1999 [36] | controlled clinical trial with a repeated measures design (single session) | number  - n = 11 setting  - University faculty of Health Science diagnoses  - history of RA age (years)  - 65 (49–82)   mean (range) clinical characteristics  - forefoot pain on shod weightbearing | Custom-made, semi-rigid (total-contact) FOs  - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.  - constructed of soft density, semi-rigid EVA  - half-length FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | – | foot function  - In-shoe plantar foot pressure (peak pressure, pressure-time integral, average pressure, time in mask)   (primary outcome)  - Gait characteristics (cadence) foot pain  - VAS pain during standing  - VAS pain during walking patient satisfaction  - Nomination of the FOs of preference |
Custom-made, semi-rigid (total-contact) FOs with additional metatarsal bars  - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.  - constructed of soft density, semi-rigid EVA  - addition of metatarsal bar (latex rubber, boomerang shape)  - half-length FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Custom-made, semi-rigid (total-contact) FOs with additional metatarsal domes  - based on the semi-weight bearing technique described by McPoil et al. (1989) using a latex rubber foot moulding board during moulding the EVA-material directly to the foot.  - constructed of soft density, semi-rigid EVA  - addition of metatarsal dome (latex rubber, teardrop shape)  - half-length FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Ready-made, soft FOs  - contoured soft density EVA FOs  - half-length FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Control intervention  - shoe-only | |||||
Jackson et al. 2004 [32] | randomized controlled trial with a repeated measures design (single session) | number  - n = 10 setting  - podiatry centre diagnoses  - definitive diagnosis of RA age (years)   61 (32–79)   mean (range) clinical characteristics  - forefoot pain on shod weightbearing | Ready-made, soft FOs with additional metatarsal bars  - manufactured of expanded urethane foam with a hardness of 25 Shore A  - addition of metatarsal square bar (latex foam, 29 Shore A)  - full-length, contoured FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | – | foot function  - In-shoe plantar forefoot pressure (peak pressure, pressure-time integral, stance time, contact area)   (primary outcome)  - Gait characteristics (cadence) patient satisfaction  - Nomination of the FOs of preference |
Ready-made, soft FOs with additional metatarsal domes  - manufactured of expanded urethane foam with a hardness of 25 Shore A  - addition of metatarsal dome (latex foam, 29 Shore A)  - full-length, contoured FOs target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | |||||
Control intervention  - shoe-only | |||||
Tenten-Diepenmaat et al. 2016 [39] | quasi-experimental clinical trial with a repeated measures design (single session) | number  - n = 45 setting  - outpatient centre for rehabilitation and rheumatology Diagnoses  - definitive diagnosis of RA age (years)   53 (13.5)   mean (range) clinical characteristics  - RA related foot  - indication for treatment with FOs | Custom-made, semi-rigid (total-contact) FOs  - constructed of prefabricated orthotic devices, custom-moulded to the patient’s foot while using the functional suspension subtalar joint neutral position technique.  - optional addition of varus-, valgus corrections, metatarsal bars, metatarsal domes, and/or cushioning material target of treatment  - support, stabilisation or correction of foot structures  - forefoot plantar pressure reduction | – | foot function  - In-shoe plantar forefoot pressure (peak pressure, pressure-time integral)   (primary outcome) |
Custom-made, semi-rigid (total-contact) FOs, with adaptations using the feedback of in-shoe plantar pressure measurements  - custom-made, semi-rigid, total-contact FOs were adapted based on the feedback of in-shoe plantar pressure measurements  - optional change or addition of   varus-, valgus corrections, metatarsal bars, metatarsal domes, and/or cushioning material target of treatment  - support, stabilisation or correction of foot structures - forefoot plantar pressure reduction | |||||
Region of interest - hindfoot | |||||
Gatt et al. 2016 [37] | controlled cross-over trial | number  - n = 10 setting  - rheumatology outpatient clinic at a general hospital diagnoses  - definitive diagnosis of RA age (years)  - 52.2 (9.1)   mean (SD) clinical characteristics  - subtalar and/or ankle joint pain ≥6 months  - need of orthoses for biomechanical mal-alignment of the feet as per clinical practice | Custom-made, semi-rigid (total-contact) FOs  - based on a cast (the positive casts were modified as outlined by Philips et al.)  - constructed of semi-rigid material (subortolene) target of treatment  - support, stabilisation or correction of foot structures | 3 months per intervention, with a 2 week washout period in between | foot pain  - FFI pain  - RAI physical functioning  - FFI disability  - FFI limitation |
Custom-made, soft (total-contact) FOs  - based on a cast (the positive casts were modified as outlined by Philips et al.)  - constructed of low density EVA target of treatment  - support, stabilisation or correction of foot structures | |||||
Region of interest - non-specified | |||||
Cho et al. 2008 [33] | randomized controlled trial | number  - n = 42   (22 intervention-group, 20 control-group) Setting  - university hospital Diagnoses  - definitive diagnosis of RA age (years)  - 48.7 (11.7)   mean (SD) clinical characteristics  - stable disease activity  - foot pathology (forefoot or hindfoot) | Custom-made, semi-rigid FOs  - consisting of a medial longitudinal arch support, medial heel post and metatarsal pad. target of treatment  - support, stabilisation or correction of foot structures | 6 months | foot pain  - VAS pain   (primary outcome) |
Ready-made, soft FOs  - simple FOs  - 6 mm plastazote target of treatment  - cushioning, full length | |||||
Pallari et al. 2010 [38] | quasi-experimental clinical trial with a repeated measures design (single session) | number  - n = 7 setting  - rheumatology outpatient clinic of a hospital Diagnoses  - definitive diagnosis of RA age (years)   53.4 (29–68)   mean (range) clinical characteristics  - current history of foot impairments | Custom-made, semi-rigid (total-contact) FOs  - based on casts  - mainly constructed of semi-rigid material  - optional addition of cushioning material target of treatment  - support, stabilisation or correction of foot structures | – | foot function  - Gait characteristics (velocity, cadence, cycle-time, stride length)   (primary outcome) patient satisfaction  - VAS orthotic comfort  - VAS orthotic fit |
Custom-made, semi-rigid (total-contact) FOs; CAD design using selective laser sintering  - the CAD design is based on a weight or nonweight-bearing scan of the foot (in a subtalar joint neutral alignment) and on design rules  - manufactured using selective laser sintering using nylon-12 powder target of treatment  - support, stabilisation or correction of foot structures | |||||
Rome et al. 2017 [34] | randomized controlled trial | number  - n = 47 setting  - rheumatology outpatient department Diagnoses  - definitive diagnosis of RA age (years)   65 (49–82)   mean (range) clinical characteristics  - history of foot pain | Custom-made, semi-rigid (total-contact) FOs  - based on a cast taken of a neutral suspension plaster  - constructed of semi-rigid material (50 Shore A)  - optional addition of external medial posting correction  - addition of cushioning material (full-length) target of treatment  - support, stabilisation or correction of foot structures  - cushioning | 16 weeks | foot pain  - FFI foot pain physical functioning  - FFI disability  - FFI functional limitation Costs of FOs  - EQ 5D utility index (QUALYs)  - mean cost of resource use |
Custom-made, soft FOs  - constructed of a 6-mm breathable foam on a rubber-silicone-ethylene compound.  - full-length FOs target of treatment  - support, stabilisation or correction of foot structures  - cushioning | |||||