Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06412055
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-02
Brief Title:
Bidirectional Tuning of the AFO Stiffness
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Optimizing Gait With Bidirectional Tuning of the Ankle-foot Orthosis AFO Stiffness in People With Lower Leg Muscle Weakness
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEUROSWING
Brief Summary:
The goal of this pilot study with a pre-post design is to investigate the effects of separate individualization of the AFO stiffness towards plantar- and dorsiflexion in a spring-hinged AFO on walking compared to a spring-like AFO 3 types having the same stiffness in both directions
People with a neuromuscular disease or nerve injury causing at least plantarflexor weakness determined as the inability to perform 3 single heel rises with an indication for or using an AFO will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING system ankle joint Fior Gentz Lüneburg In Duderstadt Germany of which the stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized For comparison measurements will be performed with three different prefab spring-like AFOs with different stiffness levels but which have a similar stiffness towards plantar and dorsiflexion and the participants current AFO if applicable and shoes-only at baseline
The main outcome parameters will be the maximal ankle plantarflexion angle ankle angular velocity and knee flexion angle during the loading response which will be measured using a 3D gait analysis Secondary outcomes include other gait biomechanics walking energy cost walking speed standing balance perceived physical functioning and perceived walking ability
People with a neuromuscular disease or nerve injury causing at least plantarflexor weakness determined as the inability to perform 3 single heel rises with an indication for or using an AFO will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING system ankle joint Fior Gentz Lüneburg In Duderstadt Germany of which the stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized For comparison measurements will be performed with three different prefab spring-like AFOs with different stiffness levels but which have a similar stiffness towards plantar and dorsiflexion and the participants current AFO if applicable and shoes-only at baseline
The main outcome parameters will be the maximal ankle plantarflexion angle ankle angular velocity and knee flexion angle during the loading response which will be measured using a 3D gait analysis Secondary outcomes include other gait biomechanics walking energy cost walking speed standing balance perceived physical functioning and perceived walking ability
Detailed Description:
Many neuromuscular diseases cause weakness of the ankle dorsiflexors and plantarflexors resulting in an altered gait pattern In particular weakness of the plantar flexors leads to a reduced walking ability as it hampers safety in both standing and walking The primary treatment to improve walking ability and safety during standing and walking in dorsiflexor andor plantarflexor weakness is the provision of ankle-foot orthoses AFOs To maximize treatment outcomes in case of lower leg weakness the optimal AFO stiffness needs to be individually determined Individual optimization of the stiffness can be performed with a spring-like AFO or with a spring-hinged AFO With a spring-like AFO the stiffness towards plantar- and dorsiflexion is similar oftentimes resulting in a higher than necessary stiffness towards plantarflexion An advantage of spring-hinged AFOs is that unlike spring-like AFOs the stiffness can be separately optimized in the directions of dorsiflexion and plantarflexion
The objective of this pilot study is to evaluate the effects of separate individualization of the AFO stiffness towards plantar- and dorsiflexion in a spring-hinged AFO compared to three types of spring-like AFO having the same stiffness in both directions on gait biomechanics walking energy cost walking speed and standing balance Additionally effects will be evaluated of the optimal spring-hinged AFO 6 weeks after delivery of the AFO on perceived physical functioning walking ability and satisfaction in daily life compared to the participants AFO used at baseline if applicable or walking with shoes-only
In this pilot study with a pre-post design people with a neuromuscular disease or nerve injury causing at least plantarflexor weakness with an indication for or using an AFO will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING system ankle joint Fior Gentz Lüneburg In Duderstadt Germany The stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized using a previously developed optimization algorithm The spring-hinged AFO with optimal stiffness settings will be used at home for 6-weeks For comparison the investigators will test the direct effects of three different prefab spring-like AFOs with different stiffness levels but which have a similar stiffness towards plantar and dorsiflexion of 28 14 and 06 Nmdegrees respectively in a randomized order and the participants current AFO if applicable and shoes-only at baseline
The objective of this pilot study is to evaluate the effects of separate individualization of the AFO stiffness towards plantar- and dorsiflexion in a spring-hinged AFO compared to three types of spring-like AFO having the same stiffness in both directions on gait biomechanics walking energy cost walking speed and standing balance Additionally effects will be evaluated of the optimal spring-hinged AFO 6 weeks after delivery of the AFO on perceived physical functioning walking ability and satisfaction in daily life compared to the participants AFO used at baseline if applicable or walking with shoes-only
In this pilot study with a pre-post design people with a neuromuscular disease or nerve injury causing at least plantarflexor weakness with an indication for or using an AFO will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING system ankle joint Fior Gentz Lüneburg In Duderstadt Germany The stiffness of ventral and dorsal compartment of this spring-hinged AFO will be individualized using a previously developed optimization algorithm The spring-hinged AFO with optimal stiffness settings will be used at home for 6-weeks For comparison the investigators will test the direct effects of three different prefab spring-like AFOs with different stiffness levels but which have a similar stiffness towards plantar and dorsiflexion of 28 14 and 06 Nmdegrees respectively in a randomized order and the participants current AFO if applicable and shoes-only at baseline
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None