Table 8 Studies using foot function measures in orthotic intervention

FFI,1995

Budiman-Mak, E [74]

Outcome measure of orthotic intervention in hallux valgus deformity

N=102

RCT double blind Intent to Treat Analysis FFI applied at baseline and each follow up visit

FFI

VAS

This study suggest that foot orthosis can prevent or slowed the progression of hallux valgus deformity

Treatment group (N: 52)

23 items

Mean age: 60.2 (SD 10.6)

3 domains

Male: 46 (88.5%)

Control group (N:50)

Mean age: 58.8 (SD 11.9)

Male: 43 (86%)

DX:RA

Location: USA

FFI, 1996

Conrad, KJ [70]

Outcome measure-Pain and function measures

N:102

RCT double blind Post –test Random effect model for longitudinal data

FFI

VAS

This study showed no benefit on pain and disability measures between treatment group and placebo group

Treatment group (N: 52)Mean age: 60.2 (SD 10) 46 male

FFI applied at baseline and at each follow up visit

23 items

Conclusion: useful

Control group (N:50) Mean age: 58.8 (SD11.9) 43 male

3 domains

Dx: RA

Location: USA

FFI, 1997

Caselli, MA [77]

Outcome measure - Effectiveness of the intervention

N: 34; Mean age: 43 (28–59) 12 male

RCT, not-blinded FFI was applied at baseline and at 4 weeks

FFI

Categorical rating scale

58% (11/19) of participants showed improvement in pain scores Conclusion: useful

Group 1: Group with magnet (N: 19)

23 items

Group 2: Group with no magnet (N: 15)

3 domains

Dx: Heel pain

Location: USA

FFI, 1997

Caselli, MA [68]

Outcome measure -Effectiveness of the intervention

N: 35; Mean age: 42 (23–65); 18 male

RCT not blinded FFI was applied at baseline and at 4 weeks

FFI

Categorical rating scale

FFI scores improved at 4 weeks reported as the following:

Group 1: Viscoped (N: 16)

23 items

60% (Group1)

Group 2: Poron (N: 12)

3 domains

43% (Group 2)

Group 3: Control(N: 7)

10% (Group 3)

Dx: Painful submetatarsal hyperkeratosis

Conclusion: useful

Location: USA

FFI, 1999

Pfeffer, G [78]

Outcome measure – primary interest is in pain subscale outcome at 8 weeks

N: 236; Mean age: 47 (23–81); 160 male

RCT not blinded 6 months interventions multi-centers. FFI was applied at baseline and at 8 week intervals At 8 weeks the group response rate was 88.2%

FFI

VAS rating scale

Pain subscale scores improved at 8 weeks

Group 1: Stretching only (N: 39) Mean age: 47 (25–81) 11 male

23 items

Pain change scores controlled for covariates. Results are reported as the following:

Group 2: Custom orthoses & stretch (N: 34) Mean age: 48.5 (23–69) 11 male

3 domains

Group 1: -17.2

Group 3: Silicon & stretch (N: 51) Mean age: 49.5 (30–75) 17 male

Group 2: -16.9

Group 4: Rubber & stretch (N: 43) Mean age: 44 (27–69) 11 male

Group 3: -23.9

Group 5: Felt & stretch (N:42) Mean age: 48 (26–76) 13 male

Group 4: -24.5

Dx: Proximal plantar fasciitis

Group 5: -20.2

Location: USA

Conclusion: useful

FFI, 2001

Slattery, M [82]

Outcome measure – effectiveness of the intervention

N: 46; Mean age: 24 (6.2) Sex not reported

Observational 6 weeks FFI applied at baseline

FFI

VAS rating scale

FFI scores of pain and disability subscales markedly improved at 6 weeks

Dx: Hemophilic foot and ankle arthropathy at level 1–5 joint damange

23items

Conclusion: useful

Location: Australia

3 domains

FFI, 2002

Gross, MT [79]

Outcome measure – Effectiveness of the intervention correlation with 100 meter walk and VAS pain scale

N: 15; 8 male

Pre-post test design FFI was applied at baseline and post orthosis at 12–17 days

FFI 18 items Pain and disability scales

VAS rating scale

Pain and disability improved. The author suggested to modify FFI items if FFI will be used for plantar fasciitis.

Mean age male: 43.8 (SD=6.3)

Conclusion: useful

Mean age female: 45.9 (SD=11.9)

Dx: Plantar fasciitis

Location: USA

FFI, 2002

Woodburn, J [80]

Outcome measure – effectiveness of the intervention

N: 98; Orthosis/vsControl

RCT double blind; 30 months study. FFI was applied at 3, 6, 12, 18, 24, and 30 months

FFI

VAS rating scale

FFI scores improved at the completion of the RCT

Orthosis (N: 50) Mean age: 54 (SD=11.8) 16 male

23 items

Conclusion: useful

Control (N: 48) Mean age: 53 (SD=11.1) 17 male

3 domains

Dx: RA rear foot valgus deformity

Location: UK

FFI, 2005

Powell, M [83]

Outcome measure – Validation of The Pediatric Pain VAS Questionnaires, Pediatric quality of life (PedQOL) inventory physical function scale

N: 40; Custom orthoses: N: 15; 2 Male Mean age: 12.14

RCT 3 arms, Single blinded

FFI

VAS rating scale

The largest improvement of FFI scores was in the custom orthoses. VAS scoring appears applicable in children

Insert N: 12; 4 Male Mean age: 12.7

Intent to Treat Analysis; ANOVA

23 items

Conclusion: useful

Athletic shoes N: 13; 4 Male Mean age: 13.77

FFI was applied at baseline and at 3 months

3 domains

Dx: JRA and foot pain

Location: USA

FFI, 2006

Magalahaes, E [69]

Outcome measure – Concurrent measure with Health Assessment Questionnaires (HAQ)

N: 36; 5 Male

Prospective observational

FFI

VAS rating scale

FFI scores in pain, disability, activity limitation improved; no correlations with HAQ scores

Orthosis N: 28

2 treatment groups; 6 months trial

23 items

Conclusion: useful

Sham N: 8

FFI was applied at baseline, 30, 90, and 180 days

3 domains

Mean age: 46 (32–68) RA years 11 (1–34)

Location: Brazil

FFI, 2007

Williams, AE [71]

Outcome measure – Concurrent measure with FHSQ for designed shoes intervention

N: 80; 35 male

Age: N/A

RCT single blinded; 12 weeks trial. FFI was applied at baseline and 12 weeks N:34 completed the study

FFI

VAS rating scale

Both scores of FFI and FHSQ were improved at 12 weeks

Group 1: Designed shoes (N: 40); 11 male

23 items

Between groups general health was unchanged

Group 2: Traditional shoes (N: 40) 19 male

3 domains

Conclusion: useful

RA 17 years (14.4 yrs)

Dx: Hallux valgus

Location: UK

FFI, 2008

Lin, JL [81]

Outcome measure – Validation with AOFAS VAS pain scale SF-36

N: 32; 6 male

Observational 7–10 years (mean 8.8 years); FFI was applied at the end of the observation

FFI scores for pain and disability were improved and well correlated with AOFAS scores

Dx: Stage II posterior tibialis tendon dysfunction (PTTD)

Conclusion: useful

Location: USA

FFI, 2009

Cho, NS [72]

Outcome measure – Validation with VAS pain scale

N: 42; Semi-rigid insole: N: 22

RCT single blinded 6 month trial FFI was applied at baseline and 6 month At 6 months N34 completed the study

FFI

VAS rating scale

Semi-rigid insole group showed markedly improved FFI scores

0 male

11fore foot/11 hind foot

23 items

Conclusion: useful

Mean age: 48.7 (SD=11.6)

3 domains

Soft insole: N: 20; 0 male 11 fore/10 hind foot

Mean age: 48.7 (SD=11.7)

Dx: RA foot deformity, hind or forefoot

Location: Korea

FFI, 2009

Novak, P [84]

Outcome measure – Correlation with 6 minute walk time

N: 40; Mean age: 56.23; 2 male

RCT double blinded 6 months trial FFI was applied at baseline visits 1, 2, and 3 at 6 months

FFI

VAS rating scale

Pain improved correlation with 6 minute walk time was moderate

Orthosis (N: 20) Mean age: 55.7 (SD=9.31) RA: 10.5 yrs (SD=8.17)

9 items

Conclusion: useful

Control (N: 20) Mean age: 56.75 (SD=11.1) RA: 11.5 yrs (SD=6.86)

Pain scale

Dx: RA

Location: Slovenia

FFI, 2009

Baldassin, V [35]

Outcome measure – pain relief

N: 142; Custom Orthosis: N=72

RCT double blind; 8 weeks trial. FFI was applied at 4 and 8 weeks

FFI

VAS rating scale

Less pain was observed in both groups but no significant differences between groups

Mean age: 55.7 (SD=12.4)

23 items

Conclusion: useful

RA: 47.2 yrs (SD=8.17) 51 male

3 domains

Prefabricated orthosis: N=70

Pain subscales 9 items (modified)

Mean age: 47.5 (SD=11.5)

Dx: Plantar fasciitis

Location: Brazil

FFI-R, 2009

Rao, S [75]

Outcome measure – FFI-R scores translated to clinical measure MDC₉₀, Correlation with medial mid-foot pressure loading

N: 20; 0 male

Intervention 4 weeks FFI-R was applied at pre and post intervention Statistician was blinded from data sources

FFI-R

Likert

Total FFI-R scores improved correlated with significant reduction in pressure loading of the medial aspect of the midfoot

Mean age: 63 (55–78)

68 items

Conclusion: useful

Full length orthosis

Long form

Dx: Midfoot arthritis

Location: USA

FFI-R, 2010

Rao, S [76]

Outcome measure – Clinical measure MDC 90 validation with segmental foot kinematic values

N: 30; 2 male

Intervention 4 weeks FFI-R was applied at pre and post intervention

FFI-R

Likert

Full length foot orthoses reduced motion of the 1^st metatarsophalangeal and was significantly correlated with FFI-R scores

Mean age: 62 (47–78)

68 items

Conclusion: useful

Full length carbon graphite orthosis

Long form

Dx: Midfoot arthritis

Location: USA

FFI, 2010

Welsh, BJ [73]

Outcome measure – validation with foot kinematic values VAS pain scale

N: 32; 6 male

Case series 24 weeks Pre-post test design

FFI

VAS rating scale

FFI pain subscale significantly improved and met the criteria of equivalence to analgesic response. This pain reduction was not correlated with that of the biomechanical changes of the 1^st metatarsophalangeal joint.

Mean age: 42 (SD=11.5)

9 items

Conclusion: useful

Pre-fabricated vs. custom orthosis

Pain subscale

Dx: MTP joint pain

Location: UK

FFI, 2010

Clark H [85]

Outcome measure – Orthosis reduced pain and disability and correlated with gait parameter

N: 41; Gender not reported

RCT single blind 16 weeks trial. FFI was applied at baseline, 8 and 16 weeks

FFI

VAS rating scale

FFI scores were improved in orthoses and simple insole groups but the intervention did not improve gait parameter.

Orthosis: N: 20; Simple insole: N: 21

23 items

Conclusion: useful

Age>18 years; RA>3 years

3 domains

Location: New Zealand