Table 8.
Studies using foot function measures in orthotic intervention
| Instrument | 1st Author | Study and objective | Population (N, Sex, Age, Dx, location) | Methods & Analyses | Items/Domains/ Subscales | Measurement scale | Summary evaluation |
|---|---|---|---|---|---|---|---|
| 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 1st 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 1st 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 |