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Table 1 Literature review with respect to the papers reporting on the functional evaluation of custom PD-AFOs. For each paper, when present, it is reported the AFO type(s), the customization criteria, the materials, the functional data/parameters, and the main outcome. Comfort assessment or other subjective scores are also reported

From: Design principles, manufacturing and evaluation techniques of custom dynamic ankle-foot orthoses: a review study

Authors/year

Population

(size)

AFO type/ customization criteria

Material

Motor tasks

Functional parameters

Other scores

Main outcome

Waterval et al. 2021

[56]

unilateral plantar flexor weakness

(9)

dorsal leaf spring AFO

Spring leaf Stiffness customizable

energy cost optimized (Ankle7, OttoBock)

carbon fiber

walking

spatio-temporal parameters

GRFs

hip, knee, ankle kinematics and kinetics

 

peak vertical GRF of the contralateral leg significantly reduced and symmetry improved (AFO vs. no AFO)

Waterval et al. 2021 & 2020

[32, 33]

calf muscle weakness

(34)

dorsal leaf spring AFO

Spring leaf Stiffness customizable

(Ankle7, OttoBock)e

carbon fiber

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

energy cost

 

reduction in energy cost (AFO optimized stiffness vs. non optimized)

Kerkum et al. 2021

[35]

healthy subjects

(12)

dorsal leaf spring AFO

Spring leaf Stiffness customizable

(Ankle7, OttoBock)

carbon fiber

walking

Ankle-foot kinematics work and power

 

Total ankle-foot power increase with increasing footplate stiffness

Lin et al. 2021

[57]

post-stroke drop-foot

(12)

1. energy-Storage 3D Printed AFO

2. anterior-support AFO

PLA + nylon+titanium

thermoplastic

walking

spatio-temporal parameters

pelvis, hip, knee, ankle kinematics (sagittal plane)

Evaluation of satisfaction (QUEST)

increased gait velocity and stride length (AFO1 vs. AFO2; AFO1 vs. barefoot)

improved satisfaction (AFO1)

Meng et al. 2021 [58]

post-stroke drop-foot

(15)

morphology

PA2200

Somos NeXt

PA12

NA

NA

comfort

weight feeling

surface smoothness wearing issues

cleaning issues

Somos NeXt scored better than one or more materials in comfort and surface smoothness

Vasiliauskaite, et al. 2020

[51]

child with unilateral drop-foot

(1)

1. hinged AFO with adjustable ankle stiffness

2. posterior leaf spring

stiffness tuned to achieve the orthotic goals

thermoplastic+metal

polyamide-12

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

Despite having the same ankle stiffness, AFO1 and AFO2 did not produce the same gait pattern

Chae et al. 2020 [59]

unilateral drop-foot (1)

morphology

polyurethane

walking

stairs ascent/descent

up&go

NA

Modified Emory Functional Ambulation Profile

improved mEFAP (AFO vs. no-AFO)

Esposito et al. 2020

[22]

unilateral lower limb reconstruction

(12)

IDEO custom AFO (posterior leaf spring)

Stiffness based body mass, load carriage requirements, and range of available pain-free motion

carbon fiber

walking

COP position

COP velocity

NA

±3 deg in strut flexion/extension strut alignment does not significantly affect the foot-ankle roll-over shape radius

Liu et al. 2019 [11]

post-stroke drop-foot (12)

morphology

PA12

walking

spatio-temporal parameters

hip, knee, ankle kinematics

NA

improved velocity and stride length (AFO vs.no-AFO)

Waterval et al. 2019

[50]

neuromuscular disorders and non-spastic calf muscle weakness

(37)

dorsal leaf spring AFO (Carbon Ankle Seven, Ottobock, Duderstadt) adjustable stiffness

carbon fiber

walking

energy cost

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

energy cost −20% (optimal AFO vs. no-AFO)

energy cost − 10.7% (optimal AFO vs. non-optimal AFO)

Cha et al. 2017

[44]

unilateral drop-foot

(1)

1. sock-like design with anterior opening and malleoli holes

2. rigid AFO

thermoplastic polyurethane

walking

spatio-temporal parameters

ankle kinematics

Evaluation of satisfaction (QUEST)

insufficient ankle dorsiflexion in swing (AFO1 vs AFO2)

better wearing properties and comfort (AFO1 vs AFO2))

Esposito et al. 2017

[23]

unilateral lower limb reconstruction

(24)

IDEO custom AFO (posterior leaf spring)

Stiffness based body mass, load carriage requirements, and range of available pain-free motion

carbon fiber

walking

spatio-temporal parameters

hip, knee, ankle kinematics (sagittal plane)

NA

limited power capabilities at the ankle, and reduced compensatory strategies at the knee with respect to amputees

Arch & Reisman 2016

[34]

post-stroke

(2)

custom AFOs

Morphology-based, no shoe required

polycarbonate

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

increased net peak plantarflexion moment and natural ankle pseudo-stiffness.

Whitehead et al. 2016

[60]

unilateral lower limb reconstruction

(13)

normal/healthy

(13)

IDEO custom AFO (posterior leaf spring)

carbon fiber

stairs ascent/descent

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics (sagittal plane)

NA

stair ascent: greater bilateral hip power during pull-up and reduced ankle dorsiflexion and knee extensor moment (AFO vs. control)

Ranz et al. 2016

[38]

unilateral ankle muscle weakness

(13)

IDEO custom AFO (posterior leaf spring)

3 bending axis positions

carbon fiber

nylon 11 (strut)

walking

sEMG: soleus, gastrocnemius, tibialis ant., rectus fem., biceps fem., vastus med. and gluteus med.

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

hip and knee moments were affected by bending axis position

no difference in spatio-temporal parameters

Arch & Stanhope 2015

[43]

normal/healthy

(2)

passive dynamic AFO (posterior leaf spring)

AFO stiffness according to natural ankle pseudo-stiffness

not reported

walking

Ankle kinematics and moments (sagittal plane)

NA

 

Haight at al. 2015

[25]

unilateral lower-limb reconstruction

(12)

IDEO custom AFO (posterior leaf spring)

variable stiffness based on ROM, activity level, types of activities, body mass, load carriage requirements

carbon fiber

treadmill uphill walking (10 deg slope)

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

AFOs stiffer than nominal increased knee joint flexion

Kerkum et al. 2015 & 2016, Meyns et al. 2020

[27, 28, 61]

children with cerebral palsy

(15; bilateral 14)

ventral shell spring-hinged AFO (vAFO)

variable stiffness/ROM hinge

pre-preg carbon fiber

waking

energy cost

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

decreased net energy cost (vAFOs vs. no-AFO)

no differences between vAFOs

Harper et al. 2014

[42]

unilateral ankle muscle weakness

(10)

IDEO custom AFO (posterior leaf spring)

clinically prescribed stiffness

carbon fiber

nylon 11 (strut)

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

no difference in kinematics/kinetics between the two materials (same AFO stiffness)

Esposito et al. 2014

[24]

unilateral ankle muscle weakness

(13)

healthy controls

(13)

IDEO custom AFO (posterior leaf spring)

variable stiffness based on ROM, activity level, types of activities, body mass, load carriage requirements

carbon fiber

nylon 11 (strut)

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

small differences in kinematics and kinetics (nominal stiffness vs. stiffer and more compliant)

Dufek et al. 2014

[29]

Charcot–Marie–Tooth patients

(bilateral 8)

posterior leaf spring AFO

stiffness customization based on prior experience,

visual observations of patient’s gait,

weight and muscle strength, and amount of ankle deformity

carbon-fiber composite

walking

spatio-temporal parameters

hip, knee, ankle kinematics and kinetics

NA

increased walking speed and stride length (custom AFO vs. no-AFO)

AFO energy storage 9.6 ± 6.6 J/kg

Creylman et al. 2013

[8]

unilateral drop foot

(8)

morphology-based posterior leaf spring/shell

nylon 12 (AFO1)

polypropylene (AFO2)

walking

spatio-temporal parameters

hip, knee, ankle kinematics (sagittal plane)

NA

improved spatial temporal gait parameters and ankle kinematics (AFO1 & AF2 vs. no-AFO)

Mavroidis et al. 2011

[7]

normal/healthy

(1)

morphology-based posterior leaf spring/shell (based on Type C-90 Superior Posterior Leaf Spring, AliMed)

polypropylene (AFO1, standard)

Accura SI 40 (AFO2)

Somos 9121 (AFO3)

walking

spatio-temporal parameters

ankle kinematics and kinetics (sagittal plane)

comfort

comparable functional outcome to standard AFO and better comfort (AFO2 and AFO3 vs AFO1)

Lewallen et al. 2010

[62]

post-stroke drop-foot

(13)

solid AFO

vs.

hinged

vs.

posterior leaf spring

thermoplastics

walking

walking up/down 10 deg ramp

spatio-temporal parameters

NA

significantly reduced walking speed and stride length (solid AFO vs. all AFOs and no-AFO)

only one subject preferred solid AFO over the other AFOs

Bartonek et al. 2007

[31]

children with bilateral ankle muscle weakness

(11 AFO; 6 KAFO)

morphology-based posterior leaf spring

patient’s level of functional ambulation and body weight

pre-preg carbon-fiber

walking

spatio-temporal parameters

hip, knee, ankle kinematics (sagittal plane)

frequency of use

gait

standing function changes

walking velocity

acceptance

ease of putting on and removing

for most children, improved ankle plantarflexion moment (p < 0.001), ankle positive work (p < 0.001), and stride length (p < 0.001)

(custom AFO vs. rigid shell thermoplastic AFO)

Bartonek et al. 2007

[30]

children with bilateral ankle muscle weakness

(2 AFO; 1 KAFO)

morphology-based posterior leaf spring

patient’s level of functional ambulation and body weight

pre-preg carbon-fiber

walking

spatio-temporal parameters

hip, knee, ankle kinematics (sagittal plane)

frequency of use

gait

standing function changes

walking velocity

acceptance

ease of putting on and removing

increased stride length (2/2; custom AFO vs. rigid shell thermoplastic AFO)

increased walking speed (1/2)

perceived improved gait

Desloovere et al. 2006

[63]

children with hemiplegia

(15)

flexible posterior leaf-springs (PLS)

Dual Carbon Fibre Spring AFO (CFO)

clinical examination and gait analysis

thermoplastic

thermoplastic & carbon and kevlar fibres pre-impregnated with epoxy (strut)

walking

spatio-temporal parameters

hip, knee, ankle kinematics

NA

increased walking speed and stride length (PLS vs. no-AFO)

larger ankle ROM and ankle velocity during push-off

increased plantar flexion moment and power generation at pre-swing (CFO vs. PLS; p < 0.01).

Gök et al. 2003

[64]

hemiparetic stroke patients

(12)

1. Seattle-type polypropylene AFO

2. metallic AFO

polypropylene

metal

walking

spatio-temporal parameters

hip, knee, ankle kinematics

NA

increased walking speed (AFO2 vs AFO1 vs. no-AFO)

increased stride length (AFO1 vs. no-AFO; AFO2 vs. no-AFO)

Sienko Thomas et al. 2002

[65]

children spastic hemi-plegia

(19)

morphology-based

1. hinged AFO

2. posterior

leaf spring (PLS)

3. solid AFO

thermoplastic

walking

stairs ascent/descent

spatio-temporal parameters

pelvis, hip, knee, ankle kinematics (sagittal plane)

Pediatric Evaluation of Disability Inventory (PEDI)

reduced ankle plantarflexion (AFOs vs. barefoot)

Burtner et al. 1999

[66]

children with spastic diplegic cerebral palsy

(4, and 4 healthy control)

1. solid AFO

2. dynamic (spiral) AFO

Polypropylene

graphite

static balance test

sEMG: gastrocnemius, tibialis ant.,

hamstrings, quadriceps, paraspinals, abdominals.

hip, knee, ankle kinematics (sagittal plane)

NA

decreased activation of gastrocnemius, disorganized muscle-response patterns, decreased use of ankle strategies, increased knee joint angular velocity (AFO1 vs. AFO2 and AFO1 vs no-AFO) without AFOs or with dynamic AFOs.