Effects of Pilates Exercises on Gait Variability in Spatiotemporal and Kinematic Parameters in People with MS Compared to Healthy Individuals

Investigating the effect of Pilates exercises on the variability of spatiotemporal and kinematic gait parameters in individuals with multiple sclerosis and comparing them with healthy individuals.

Study design: A parallel, randomized, assessor-blind trial with three groups (Healthy, MS Control, MS Intervention) in 24 participants (16 with MS, 8 healthy). MS participants were allocated via block randomization after health-based stratification. Phase: Not applicable.

This clinical trial was conducted on female members of the MS Association in Hamadan. Participants were divided into three groups (healthy, MS control, MS intervention). The intervention group received a Pilates exercise program (8 weeks, 3 sessions/week) under the supervision of an instructor. The other two groups only underwent assessment. Gait data were collected in the laboratory using a Vicon 3D motion analysis system. Blinding: The study was assessor-blind. The outcome assessor was unaware of the participants' group allocation. Participants and the instructor could not be blinded due to the nature of the intervention.

Inclusion: Adults (>18) with definitive MS (McDonald criteria), able to walk 100m independently, willing to participate. Exclusion: Other neurological diseases, MS relapse in past 3 months, musculoskeletal, cardiopulmonary, or psychiatric/cognitive conditions affecting gait or exercise, recent core-stability exercise (e.g., Pilates).

1. Healthy Control: No exercise intervention 2. MS Control: Usual care 3. MS Intervention: Pilates exercise program for 8 weeks, 3 sessions/week.

Variability of spatiotemporal gait parameters; Variability of kinematic gait parameters.

This study employed a two-stage stratified randomization design. First, participants were divided into two main strata based on their health status (healthy or with MS). Then, only participants in the "with MS" stratum were randomly allocated to two subgroups. Step-by-Step Description: Primary Stratification (Non-Random): Stratum 1 (Healthy Control Group): All eligible healthy participants were assigned to this group non-randomly, based solely on their health status. No randomization process was applied to this stratum. Secondary Stratification and Randomization: Stratum 2 (Participants with MS): All eligible participants diagnosed with MS were placed in this stratum. Randomization Method within this Stratum: Individuals in this stratum were allocated to the following two groups using Block Randomization via the randomization.com website: MS Control Group (no exercise) MS Intervention Group (receiving Pilates exercises) Unit of Randomization: The unit of randomization was individual, but this was applied only to participants in the "with MS" stratum. Sequence Generation: The allocation sequence for the MS stratum was generated by the website using variable block sizes and an equal allocation ratio (1:1) for the "MS Control" and "MS Intervention" groups. Allocation Concealment: To prevent bias in the allocation of participants with MS, the Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) method was used. The generated allocation numbers were placed inside opaque envelopes, which were then sealed and numbered sequentially. After confirming the eligibility and completing the baseline assessment of a participant with MS, the researcher opened the next consecutive envelope and directed the individual to the specified group (control or intervention). Allocation concealment was not applicable for the healthy group.

ue to the non-pharmacological and behavioral nature of the intervention (Pilates exercises), it was not possible to blind the participants or the personnel administering the intervention. Individuals who were blinded and the procedure: Primary Outcome Assessor: This study was designed as assessor-blind. The individual responsible for measuring and recording the primary and final data related to the main study variables (spatiotemporal and kinematic gait parameters) was blinded to the participants' group allocation. Method: The assessor was stationed in a separate location and only met with participants for baseline and post-test assessment sessions. The list of participants provided to the assessor contained only a unique identification code with no indication of health status (healthy or with MS) or group allocation (control or intervention). The assessor had no access to participants' medical records or exercise schedules. The assessment protocols were standardized to ensure that conversations with participants did not reveal any information about their intervention type or group. Individuals who were not blinded: (Blinding was not possible due to the nature of the intervention) Participants: All participants were aware of their own group (healthy control, MS control, or MS intervention). Principal Investigator and Executive Personnel: The Pilates instructors and the researcher coordinating the exercise sessions were fully aware of the participants' group allocations. Data Safety and Monitoring Board (if applicable): This committee was fully informed of all study details, including group allocations. Data Analyst: For the statistical analysis, raw data were provided to the analyst using non-identifiable codes (e.g., Group_A, Group_B, Group_C) to allow for blinding during the initial analysis phase. The codes were revealed for the final interpretation of results after the primary analysis was completed.

(This section is not applicable at this time. Details will be provided if a decision is made to share the data in the future.)

If a final decision is made to share the anonymized individual participant data, access will be provided after the final thesis defense and publication of the main study results. The exact date will be announced upon completion of the university's administrative processes.

If shared, de-identified data will be accessible for legitimate research requests from researchers and students affiliated with recognized academic institutions or research centers, following review and approval of the request. Access for commercial purposes is not intended.

The data may be used solely for legitimate research purposes and for replication or meta-analysis of studies related to the thematic area of this research (e.g., the effects of exercise on gait parameters in neurological disorders). Conditions of Use: Submission of a brief research proposal outlining the objective, methodology, and necessity of using the data. A written commitment to: Use the data for non-commercial purposes. Acknowledge the original source of the data (this study) in any subsequent publication. Not attempt to re-identify participants. Share any manuscript or result derived from this data for final review prior to publication. Approval of the request by a supervisory committee consisting of the main supervisor and principal investigator. Any use outside this framework or without written agreement is not permitted.

Respected applicants may submit their request as follows: Primary Contact: Email of the study supervisor Name: Dr. Mehdi Majlesi Email Address: m.majlesi@iau.ac.ir

Submission of Request: The applicant submits a complete request, including the proposal and commitment letter, to the specified email address. Initial Review (Approximately 2 weeks): The request is reviewed for completeness and compliance with initial conditions (research objectives, commitments). If incomplete, the applicant will be asked to provide additional information. Review by Committee (Approximately 4 weeks): The complete request is referred to the supervisory committee (the main supervisor and principal investigator) for a decision based on scientific merit, available resources, and ethical considerations. Notification of Outcome: The result of the review (approval, rejection, or request for modification) is communicated to the applicant via email. Signing Agreement and Data Transfer (Approximately 2 weeks): If approved, a Data Transfer Agreement is sent to the applicant for signature. Upon its signed return, the de-identified data will be provided in a secure format (e.g., via an encrypted download link). Total Time Estimate: From the submission of a complete request to data receipt (if approved), the process typically takes between 6 to 8 weeks. This timeframe may vary depending on the volume of requests and the committee's schedule.