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. 2019 Jun 13;12:32. doi: 10.1186/s13047-019-0338-x

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

VAS visual analogue scale, RB Robinson Bashall Functional Assessment, TADL Toronto Activities of Daily Living Measure, FFI foot function index, NRS numeric rating scale, EVA Etylene Vinyl Acetate, RAI Ritchie Articular Index, QUALYs quality-adjusted life years, * performance based