Neuromuscular Disorders Clinical Trial
— NEUROSWINGOfficial 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 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.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age 18 years or older; 2. 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; 3. Indicated for or using an AFO; 4. Ability to walk 6-minutes consecutively (with assistive device, if necessary). Exclusion Criteria: 1. When wearing the AFO, not able to walk short bouts of 10m without walking aids, such as a walker; 2. Foot deformities that do not fit in prefab spring-like AFOs; 3. Weakness of the knee extensor muscles, for which a knee-ankle-foot orthosis is indicated. |
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of rehabilitation medicine Amsterdam UMC, location AMC | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | FIOR & GENTZ |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | number of participants with adverse events | Adverse events are defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product or experiments. The following adverse events reported spontaneously by the subject or observed by the investigator or his staff will be recorded; pressure sores, muscle soreness, pain, and falls. | from baseline to 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO | |
Primary | maximal ankle angular velocity in loading response in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) | |
Secondary | maximal ankle angular velocity in loading response | measured during a 3D gait analysis | 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO | |
Secondary | minimal ankle angle in loading response in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | ankle angle during midstance in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal ankle angle during the stance phase in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal ankle moment in Nm/kg | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal ankle push-off power in Watt/kg | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal knee flexion angle in loading response in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | minimal knee flexion angle during the stance phase in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal external knee flexion moment in loading response in degrees | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | minimal external knee flexion moment during the stance phase in Nm/kg | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal hip power during loading response in Watt/kg | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | maximal hip power during ankle push-off in Watt/kg | measured during a 3D gait analysis | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | walking speed in m/s | Walking speed will be measured during a 6-minute walk test (6MWT) at a self-selected comfortable speed. | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | 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. | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | 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. | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | 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. | day 0 (directly post-delivery) and 6 weeks post-delivery for the stiffness-optimized NEURO SWING AFO only | |
Secondary | 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). | baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO | |
Secondary | 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). | baseline and 6 weeks post-delivery of the stiffness-optimized NEURO SWING AFO |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02235090 -
Study of Feasibility to Reliably Measure Functional Abilities' Changes in Nonambulant Neuromuscular Patients Without Trial Site Visiting
|
N/A | |
Completed |
NCT04411732 -
Myotonia and Muscle Stiffness in NMD
|
||
Completed |
NCT00993161 -
Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder
|
N/A | |
Recruiting |
NCT02400528 -
Prospective Cohort Follow-up of French Patients With Profound and Multiple Disabilities: Healthcare Pathways and Quality of Life Among Patients and Their Families
|
N/A | |
Recruiting |
NCT01563705 -
Prospective Follow-up of Patients With Glycogen Storage Disease Type III
|
N/A | |
Completed |
NCT02780531 -
Genetic and Blood Biomarkers in Neurological and Neuromuscular Diseases
|
||
Recruiting |
NCT02833168 -
Screening Questionnaire for Respiratory Muscle Weakness and Sleep-disordered Breathing in Neuromuscular Disorders
|
N/A | |
Withdrawn |
NCT01991535 -
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern
|
N/A |