Neuromuscular DisordersNEUROSWINGNCT06412055
Bidirectional Tuning of the AFO Stiffness
A study testing NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany), WalkOn Reaction® (Ottobock, Duderstadt) and Matrix Max2® (TruLife, Dublin, Ireland) in people with Neuromuscular Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Disorders
- What is being tested?
- NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany), WalkOn Reaction® (Ottobock, Duderstadt) and Matrix Max2® (TruLife, Dublin, Ireland)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 May 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Presence of plantar flexor weakness in at least one leg, determined as a score lower than 5 on the manual muscle testing scale (Medical Research Council- MRC) and/or inability to perform three single heel rises, with or without dorsiflexion weakness;
- Indicated for or using an AFO;
- Ability to walk 6-minutes consecutively (with assistive device, if necessary).
Who cannot join
- When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker;
- Foot deformities that do not fit in prefab spring-like AFOs;
- Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Department of rehabilitation medicine Amsterdam UMC, location AMC
Amsterdam, 1105AZ
Merel Brehm, PhD, + 31 20 5663669, m.a.brehm@amsterdamumc.nl
About this study
Official title: Optimizing Gait with Bidirectional Tuning of the Ankle-foot Orthosis (AFO) Stiffness in People with Lower Leg Muscle Weakness
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, 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.
Read the 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 and/or 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, 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 2.8, 1.4 and 0.6 Nm/degrees respectively in a randomized order, and the participants' current AFO if applicable, and shoes-only at baseline.
- Conditions
- Neuromuscular Disorders
- Being tested
- NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany), WalkOn Reaction® (Ottobock, Duderstadt), Matrix Max2® (TruLife, Dublin, Ireland), Matrix® (TruLife, Dublin, Ireland)
- Keywords
- Neuromuscular disorders, dorsiflexor and plantarflexor weakness, ankle-foot orthosis (AFO), bidirectional stiffness tuning, Gait kinetics and kinematics, Walking energy cost, Perceived physical functioning
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)Device
stiffness-optimized custom-made spring-hinged AFO with the NEURO SWING® system ankle joint build in
WalkOn Reaction® (Ottobock, Duderstadt)Device
comparator: prefab spring-like AFO without hinge with a predefined stiffness (2.8 Nm/degree).
Matrix Max2® (TruLife, Dublin, Ireland)Device
comparator: prefab spring-like AFO without hinge with a predefined stiffness (1.4 Nm/degree)
Matrix® (TruLife, Dublin, Ireland)Device
comparator: prefab spring-like AFO without hinge with a predefined stiffness (0.6 Nm/degree)
| Study group | Role | What they receive |
|---|---|---|
| NEURO SWING AFO | Experimental | Participants will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING® system ankle joint. Following a previously developed algorithm, the stiffness will be individually selected from six different configurations tested during an optimization measurement directly after delivery of the new AFO. Thereafter, participants will use the optimized AFO with individualized stiffness at home for six weeks during the course of the study. Receives: Device: NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany); Device: WalkOn Reaction® (Ottobock, Duderstadt); Device: Matrix Max2® (TruLife, Dublin, Ireland); Device: Matrix® (TruLife, Dublin, Ireland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximal ankle angular velocity in loading response in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery)
Secondary outcomes (18)
maximal ankle angular velocity in loading response
measured during a 3D gait analysis
Measured: 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO
minimal ankle angle in loading response in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
ankle angle during midstance in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle angle during the stance phase in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle moment in Nm/kg
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle push-off power in Watt/kg
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal knee flexion angle in loading response in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
minimal knee flexion angle during the stance phase in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal external knee flexion moment in loading response in degrees
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
minimal external knee flexion moment during the stance phase in Nm/kg
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal hip power during loading response in Watt/kg
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal hip power during ankle push-off in Watt/kg
measured during a 3D gait analysis
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
walking speed in m/s
Walking speed will be measured during a 6-minute walk test (6MWT) at a self-selected comfortable speed.
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
walking energy cost in J/kg/m
During a 6-minute walk test (6MWT) at comfortable speed, oxygen uptake (VO2) and carbon dioxide production (VCO2) will be measured using a breath-by-breath gas analysis system (K5, Cosmed, Rome, Italy) worn on the patient's back. Over at least one minute during the last three minutes of the test, walking energy cost will be calculated from these measured parameters and the comfortable walking speed.
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
velocity of center-of-pressure displacement in mm/s
During the 3D gait analysis, a standing balance test will be performed. Participants will stand on one force plate with a standardised distance of 10 cm between the medial borders of the feet for 30 seconds. Standing posture, in terms of joint angles, will be determined using the markers placed according to the Plug-in-Gait model. Postural sway will be calculated as the Center-of-Pressure displacement during the last 15 seconds of the test.
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
center-of-pressure displacement in mm
During the 3D gait analysis, a standing balance test will be performed. Participants will stand on one force plate with a standardised distance of 10 cm between the medial borders of the feet for 30 seconds. Standing posture, in terms of joint angles, will be determined using the markers placed according to the Plug-in-Gait model. Postural sway will be calculated as the Center-of-Pressure displacement during the last 15 seconds of the test.
Measured: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
Perceived walking ability
Perceived walking ability in terms of satisfaction, intensity, safety and stability during walking will be measured on a 10-point Numerical Rating Scale (NRS) ranging from 0 (worst possible score) to 10 (best possible score).
Measured: baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO
Perceived physical functioning
Physical functioning will be measured using the physical functioning scale of the 36-item short form health survey (SF-36), with range 0-100 (a higher score means a better functioning).
Measured: baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 May 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DisordersStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- pilot self-controlled intervention study with measurements of three spring-like AFOs (WalkOn Reaction® (Ottobock, Duderstadt), the Matrix Max2® (TruLife, Dublin, Ireland), and the Matrix® (TruLife, Dublin, Ireland)) having the same stiffness in both directions, and a newly custom-made spring-hinged AFO with the NEURO SWING® system ankle joint with individualized spring settings (Fior\& Gentz, Lüneburg, Germany) directly after delivery and 6 weeks post-delivery.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- FIOR & GENTZ
- Responsible party
- Principal investigator, Merel Brehm, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frans Nollet, MD PhD, Study director, Amsterdam UMC, location AMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06412055
- Sponsor's protocol ID
- NL85684.018.23
- Acronym
- NEUROSWING
- Status last verified
- Feb 2025
- First submitted
- 2 May 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual participant data (IPD) and meta data will be made available to third parties via Figshare. Other anonymized IPD and documents will be made available on request including data analyses codes such as SPSS syntaxes.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Gait with Bidirectional Tuning of the Ankle-foot Orthosis (AFO) Stiffness in People with Lower Leg Muscle Weakness
- ClinicalTrials.gov ID
- NCT06412055
- Acronym / sponsor ID
- NEUROSWING / NL85684.018.23
- Conditions
- Neuromuscular Disorders
- Keywords
- Neuromuscular disorders, dorsiflexor and plantarflexor weakness, ankle-foot orthosis (AFO), bidirectional stiffness tuning, Gait kinetics and kinematics, Walking energy cost, Perceived physical functioning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- FIOR & GENTZ
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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 and/or 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, 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 2.8, 1.4 and 0.6 Nm/degrees respectively in a randomized order, and the participants' current AFO if applicable, and shoes-only at baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- pilot self-controlled intervention study with measurements of three spring-like AFOs (WalkOn Reaction® (Ottobock, Duderstadt), the Matrix Max2® (TruLife, Dublin, Ireland), and the Matrix® (TruLife, Dublin, Ireland)) having the same stiffness in both directions, and a newly custom-made spring-hinged AFO with the NEURO SWING® system ankle joint with individualized spring settings (Fior\& Gentz, Lüneburg, Germany) directly after delivery and 6 weeks post-delivery.
| Arm | Type | Receives |
|---|---|---|
| NEURO SWING AFO | Experimental | Device: NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany), Device: WalkOn Reaction® (Ottobock, Duderstadt), Device: Matrix Max2® (TruLife, Dublin, Ireland), Device: Matrix® (TruLife, Dublin, Ireland)Participants will be fitted with a new custom-made spring-hinged AFO with the NEURO SWING® system ankle joint. Following a previously developed algorithm, the stiffness will be individually selected from six different configurations tested during an optimization measurement directly after delivery of the new AFO. Thereafter, participants will use the optimized AFO with individualized stiffness at home for six weeks during the course of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- Presence of plantar flexor weakness in at least one leg, determined as a score lower than 5 on the manual muscle testing scale (Medical Research Council- MRC) and/or inability to perform three single heel rises, with or without dorsiflexion weakness;
- Indicated for or using an AFO;
- Ability to walk 6-minutes consecutively (with assistive device, if necessary).
Key exclusion criteria (3 listed)
- When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker;
- Foot deformities that do not fit in prefab spring-like AFOs;
- Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany)stiffness-optimized custom-made spring-hinged AFO with the NEURO SWING® system ankle joint build in | Device | NEURO SWING AFO |
| WalkOn Reaction® (Ottobock, Duderstadt)comparator: prefab spring-like AFO without hinge with a predefined stiffness (2.8 Nm/degree). | Device | NEURO SWING AFO |
| Matrix Max2® (TruLife, Dublin, Ireland)comparator: prefab spring-like AFO without hinge with a predefined stiffness (1.4 Nm/degree) | Device | NEURO SWING AFO |
| Matrix® (TruLife, Dublin, Ireland)comparator: prefab spring-like AFO without hinge with a predefined stiffness (0.6 Nm/degree) | Device | NEURO SWING AFO |
Primary outcome
maximal ankle angular velocity in loading response in degrees
Time frame: day 0 (directly post-delivery)
measured during a 3D gait analysis
18 secondary outcomes
maximal ankle angular velocity in loading response
Time frame: 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO
minimal ankle angle in loading response in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
ankle angle during midstance in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle angle during the stance phase in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle moment in Nm/kg
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal ankle push-off power in Watt/kg
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal knee flexion angle in loading response in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
minimal knee flexion angle during the stance phase in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal external knee flexion moment in loading response in degrees
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
minimal external knee flexion moment during the stance phase in Nm/kg
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal hip power during loading response in Watt/kg
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
maximal hip power during ankle push-off in Watt/kg
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
walking speed in m/s
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
walking energy cost in J/kg/m
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
velocity of center-of-pressure displacement in mm/s
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
center-of-pressure displacement in mm
Time frame: day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only
Perceived walking ability
Time frame: baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO
Perceived physical functioning
Time frame: baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Yes. Anonymized individual participant data (IPD) and meta data will be made available to third parties via Figshare. Other anonymized IPD and documents will be made available on request including data analyses codes such as SPSS syntaxes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frans Nollet, MD PhD study director
Amsterdam UMC, location AMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NEURO SWING AFO (Fior& Gentz, Lüneburg, Germany), WalkOn Reaction® (Ottobock, Duderstadt) and Matrix Max2® (TruLife, Dublin, Ireland) in people with Neuromuscular Disorders, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Merel-Anne Brehm, PhD (+ 3120 5664049, m.a.brehm@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximal ankle angular velocity in loading response in degrees (time frame: day 0 (directly post-delivery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.