Actively Recruiting
Optimizing Gait with Bidirectional Tuning of the Ankle-foot Orthosis Stiffness in People with Lower Leg Muscle Weakness
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-02-05
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Lead Sponsor
F
FIOR & GENTZ
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating how customizing the stiffness of ankle-foot orthoses (AFOs) separately for upward and downward foot movements affects walking in people with neuromuscular disorders causing weakness in the lower leg muscles. This pilot study compares a new spring-hinged AFO with adjustable stiffness in both directions to three types of standard spring-like AFOs that have the same stiffness in both directions. The goal is to understand how these devices influence walking biomechanics, energy use, speed, and balance. Participants will receive a custom-made spring-hinged AFO featuring the NEURO SWING4 system ankle joint. The stiffness will be optimized individually using a special algorithm based on six different stiffness configurations tested after delivery. Participants will then use this optimized AFO at home for six weeks. At baseline, they will also be tested with three prefabricated spring-like AFOs of varying stiffness and their own AFO if they have one, as well as walking with shoes only. During the study, researchers will assess walking using 3D gait analysis to measure ankle and knee angles and velocities, along with walking energy cost, speed, standing balance, and participants' perceptions of physical function and walking ability. Measurements will be taken immediately after fitting the optimized AFO and again after six weeks of use. This comprehensive evaluation aims to clarify how individualized AFO stiffness affects mobility and daily functioning in people with lower leg muscle weakness.
CONDITIONS
Brief Title
Bidirectional Tuning of the AFO Stiffness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Plantar flexor weakness in at least one leg, shown by a muscle strength score below 5 or inability to perform three single heel rises
- Indicated for or currently using an ankle-foot orthosis (AFO)
- Ability to walk continuously for 6 minutes, with or without an assistive device
You will not qualify if you...
- Unable to walk short distances of 10 meters without walking aids like a walker when wearing an AFO
- Foot deformities that prevent fitting prefab spring-like AFOs
- Weakness of knee extensor muscles requiring a knee-ankle-foot orthosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants are fitted with a new custom-made spring-hinged ankle-foot orthosis (AFO) with individually optimized stiffness settings according to a previously developed algorithm.
1 visit (in-person) for fitting and optimization measurement directly after delivery
Duration - 6 weeks
Participants use the stiffness-optimized spring-hinged AFO at home for six weeks while effects on gait biomechanics, walking energy cost, walking speed, and standing balance are evaluated.
Regular home use with assessments at start and end of this period
Duration - 1 day
At baseline, participants test three different prefab spring-like AFOs with predefined stiffness levels and their current AFO if applicable, as well as walking with shoes only, to compare direct effects on gait.
1 baseline visit (in-person)
Duration - 1 day
Participants return for assessment of perceived physical functioning, walking ability, and satisfaction after using the optimized AFO for six weeks.
1 follow-up visit (in-person) 6 weeks post-delivery
Trial Site Locations
Total: 1 location
1
Department of rehabilitation medicine Amsterdam UMC, location AMC
Amsterdam, Netherlands, 1105AZ
Actively Recruiting
Research Team
M
Merel-Anne Brehm, PhD
E
Elza van Duijnhoven
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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