|- candidate number||22180|
|- NTR Number||NTR5170|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-mei-2015|
|- Secondary IDs||NL50511.018.14 |
|- Public Title||Optimizing ankle foot orthoses in neuromuscular diseases|
|- Scientific Title||Precision orthotics: optimizing ankle foot orthoses to improve gait in neuromuscular diseases|
|- hypothesis||Ankle foot orthoses (AFOs) of which the stiffness mode-of-action is optimized will be more effective in reducing the walking effort compared to standard AFOs. The optimal AFO stiffness at which walking effort is lowest will be determined by patient characteristics regarding anthropometrics, impairments and walking speed.|
|- Healt Condition(s) or Problem(s) studied||Neuromuscular diseases, Ankle-foot orthoses, Gait disorder|
|- Inclusion criteria||- patients with non-spastic distal weakness of the calf muscles weakness (defined as an MRC score < 5 or unable to perform > 3 heel rises);|
- age: between 18 and 80 years old;
- using an AFO or orthopedic boot (one or both sided);
- able to walk for 6 minutes with or without assistive device;
- able to walk for 10 m barefoot without assistive devices.
|- Exclusion criteria||- presence of pes equinus under weight-bearing (dorsiflexion < 0 degrees);|
- severe deformity of the ankle/foot that cannot be fitted with an AFO;
- severe weakness of the upper legs requiring a knee-ankle-foot orthosis;
- body weight > 100 kg.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-mei-2015|
|- planned closingdate||31-dec-2018|
|- Target number of participants||37|
|- Interventions||After inclusion, participants will be fitted with a new AFO. This AFO consists of a foot part, a calf casting and a replaceable carbon fiber spring. As such, stiffness of the AFO can be varied within the same orthosis. For each patient, five carbon fiber springs will be evaluated (ranging in stiffness from very flexible (K1) to very stiff (K5)), allowing the selection of the stiffness with the maximal benefit for a particular subject (i.e. with the greatest reduction in walking effort), referred to as the subjectís optimal AFO. The effect of this optimal AFO will be evaluated 12 weeks later and compared to the patients current (old) AFO. |
|- Primary outcome||The primary outcome will be walking energy cost (in J/kg/m), which will be measured during a 6-minute walk test (6MWT) at comfortable speed with simultaneous gas-analysis. Gas-analysis will be measured using the portable Cosmed K4B2 system.|
|- Secondary outcome||Secondary outcomes will include joint angles and net joint moments during gait, walking speed, perceived physical functioning, perceived fatigue, daily step activity and AFO satisfaction. |
-Joint angles and net joint moments during gait will be measured with a VICON 8-camera motion analysis system and four force plates. Patients are asked to walk along a 10 meter walkway until three successful trials are recorded to calculate gait biomechanics.
-Walking speed (m∙min-1) will be measured during a 6MWT at comfortable speed.
-Perceived physical functioning will be measured using physical functioning scale of the Medical Outcome Study 36-Item Short-Form Health Survey (SF36).
-Perceived fatigue will be assessed with the Fatigue Severity Scale (FSS).
-Daily step activity will be measured using the StepWatch3TM Activity Monitor 3.0, which is an ankle worn pedometer that that measures the average amount of steps per minute over a broad spectrum of step cadences. For adequate interpretation of the data, subjects will be asked to note their activity program during the day in a diary. Furthermore, a temperature sensitive device, called ODM, will be placed into the AFO to check the percentage of the number of steps people take with the AFO.
-AFO satisfaction is measured using a 10-point numeric rating scale. Questions about stability, intensity and performance during walking will be assessed. Furthermore, satisfaction with the outcome will be evaluated using a five-level Likert Scale.
As additional outcomes, the stiffness properties of the patientís current (old) and new AFO will be measured. Furthermore, at baseline, anthropometrics, demographics, isometric muscle strength and passive stiffness characteristics of ankle plantar flexors will be assessed.
|- Timepoints||The total study duration will be 48 months. The first 6 months of the study will be used to train the research investigator and to involve the participating centers; from 6 to 30 months, patients will be recruited for the study and baseline assessments will be performed; and from 9 to 36 months, the follow up measurements will be performed. The final 12 months will be used for analyses, and addressing the main research questions. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Niels F.J. Waterval|
|- CONTACT for SCIENTIFIC QUERIES|| Niels F.J. Waterval|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|Prinses Beatrix Fonds, Otto Bock, OIM Noppe orthopedie|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||7-mei-2015 - 15-jun-2015|