The comparison of the immediate effects of UD-Flex and PLS orthoses on spatiotemporal gait parameters in individuals with Multiple Sclerosis and Drop foot: A randomized crossover clinical study

Comparison of the immediate effect of UD-Flex and PLS orthoses on spatiotemporal gait parameters in individuals with multiple sclerosis and foot drop

A randomized,single-blind,cross-over clinical trial with 12 participants

Samples will be selected from available individuals with multiple sclerosis and foot drop at the outpatient clinics of Kashani Hospital, Isfahan, Iran. Blinding of the participants was not possible because they could see which intervention they were wearing.By coding the data, the data analyst was blinded. To prevent assessment bias, automated devices were used to measure the gait variables.

Inclusion Criteria: Individuals with multiple sclerosis and foot drop with disability score between 4 and 6 and able to walk without the assistance of a device or another person. Exclusion Criteria: Individuals who have had a relapse (exacerbation) of the disease within the past 3 months as confirmed by a physician. Individuals with impaired consciousness who cannot provide informed consent. Musculoskeletal disorders that impair the individual's walking. Individuals with severe cardiac or respiratory problems that prevent the patient's participation and the performance of tests.

Intervention1: Custom-made PLS ankle-foot orthosis fabricated at the Orthotics and Prosthetics Clinic of Kashani Hospital, Isfahan, Iran, for each patient.It is placed behind the calf and ankle, and the heel has no contact with the ground.Intervention2: Prefabricated UD-Flex orthosis from ADVANFIT INC, Japan,placed in front of the ankle,with the heel having direct contact with the ground.Control:Barefoot (without orthosis).A 10-minute rest period is provided between each test to ensure that fatigue does not affect the results.

Cadence,Walking speed,Step length,step width,Double support time

Randomization method in this study was simple randomization. Due to the cross-over design and the random order of all three conditions (barefoot, PLS orthosis, and UD-Flex orthosis), simple randomization was used to determine the sequence of testing. Given the limited sample size (12 participants) and the absence of different subgroups, block or stratified randomization methods were not required, and there were no randomization layers. The unit of randomization was the individual, and each participant independently received their own sequence of interventions. Each of the 6 possible sequences (3!) was written on cards and placed inside opaque, non-visible envelopes. The envelopes were numbered and sealed by an individual independent of the researcher. The random sequence was generated using a random number table by a person independent of the researcher before the start of the study. Considering the three conditions (barefoot, PLS orthosis, UD-Flex orthosis) and the completely random order of their execution, all 6 possible permutations (3!) were considered equally likely. For each participant, a two-digit random number was selected from the random number table, and based on the remainder of division by 6 (0 to 5), one of the 6 sequences was randomly determined. Allocation concealment was performed using opaque, sealed, sequentially numbered envelopes. The researcher was unaware of the sequence of conditions until the time of testing and opening the envelope corresponding to each patient. After recording the patient's characteristics and confirming the inclusion criteria, the corresponding envelope was opened in numerical order, and the test sequence was executed according to the envelope's contents. This method prevented bias in the allocation of intervention order. An important point is that the barefoot condition was considered the control condition (without intervention), and the randomization of its order did not change its control nature. A 10-minute rest period was provided between different tests to eliminate fatigue and carryover effects.

Since all participants are assessed under all three conditions (and are not divided into intervention and control groups), it is not possible to blind the participants or the assessor. To maintain single blinding, the data analyst will be unaware of how the intervention (type of orthosis) was allocated in each test session. For this purpose, all raw data collected by the motion analysis system will be coded before being delivered to the analyst, so that they will not be able to identify the type of intervention.

Study data (excluding personal information) will be shared with other researchers.

The data will be shared after the publication of the results or a summary of the data.

The data will be shared solely for academic purposes.

The data will be shared for teaching and research purposes of the applicants.

Individuals can request the information from the designated responsible person.

Requests must be sent via email (asiyaeimehr@rehab.mui.ac.ir).