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IRCT20251001067458N1 IRCT 2026-02-11 Islamic Azad University Pilates Exercises and Gait in MS PEG-MS Effects of Pilates Exercises on Gait Variability in Spatiotemporal and Kinematic Parameters in People with MS Compared to Healthy Individuals 2025-12-22 anticipated 24 Complete https://irct.ir/trial/88968 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A MS. 1. Healthy Control Group:This group did not receive any structured exercise intervention. They only underwent initial (baseline) and final assessments and continued their usual daily life without any new exercise program or specific supervision during the study period.2. MS Control Group (Disease Control):This group also did not receive any exercise intervention and continued their usual care. They only completed baseline and final assessments to measure the natural effects of time and the disease on gait parameters.3. MS Intervention Group:This group received a structured and supervised Pilates exercise program. Intervention Content: The exercise program included Pilates exercises based on classical methodology, focusing on Core Strengthening, Stability, Motor Control, Flexibility, and Coordination. Dosage and Duration: The exercises were conducted for 8 weeks, 3 sessions per week, each session lasting 60 minutes, under the supervision of a qualified Pilates instructor. Intensity: The exercise intensity was gradually and progressively increased based on each participant's individual ability and tolerance. Supervision: The quality of movement execution and participant safety were supervised by the instructor in all sessions.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The final decision regarding the sharing of anonymized individual participant data (IPD) is subject to the final approval of the university and the supervising professors, as well as full compliance with the ethical regulations governing the thesis. No specific plan has been defined at this time.
public Mahdi Majlesi
Hamadan, Shahid Madani Town, Imam Khomeini Blvd., Professor Musivand Blvd., Islamic Azad University, Hamadan Branch Complex
Hamedan Iran (Islamic Republic of) 6518115743 +86 813 448 1200 m.majlesi@iau.ac.ir Islamic Azad University scientific Mahdi Majlesi
Hamadan, Shahid Madani Town, Imam Khomeini Blvd., Professor Musivand Blvd., Islamic Azad University, Hamadan Branch Complex
Hamedan Iran (Islamic Republic of) 6518115743 +98 81 3448 1200 m.majlesi@iau.ac.ir Islamic Azad University Iran (Islamic Republic of) A definite MS diagnosis according to the revised McDonald criteria Age over 20 years Walking 100 meters independently Willingness to participate 20 years 45 years Female Any neurological disease other than MS Relapse within the past 3 months Orthopedic disorders that could negatively affect gait and balance Cardiopulmonary problems that could prevent performing the exercises Diagnosed psychiatric problems or cognitive decline that renders the individual incapable of performing the tests and exercises Current or recent (within the prior 6 months) participation in a core stability-based exercise program Rehabilitation 1. Healthy Control Group:This group did not receive any structured exercise intervention. They only underwent initial (baseline) and final assessments and continued their usual daily life without any new exercise program or specific supervision during the study period.2. MS Control Group (Disease Control):This group also did not receive any exercise intervention and continued their usual care. They only completed baseline and final assessments to measure the natural effects of time and the disease on gait parameters.3. MS Intervention Group:This group received a structured and supervised Pilates exercise program. Intervention Content: The exercise program included Pilates exercises based on classical methodology, focusing on Core Strengthening, Stability, Motor Control, Flexibility, and Coordination. Dosage and Duration: The exercises were conducted for 8 weeks, 3 sessions per week, each session lasting 60 minutes, under the supervision of a qualified Pilates instructor. Intensity: The exercise intensity was gradually and progressively increased based on each participant's individual ability and tolerance. Supervision: The quality of movement execution and participant safety were supervised by the instructor in all sessions. 1. Primary Outcome Measure #1: Title: Variability of Spatiotemporal Gait Parameters Operational Definition: The degree of fluctuation in time- and space-related parameters of the gait cycle, calculated using the Coefficient of Variation (CV). These parameters include gait speed, step length, double support time, and other listed variables in the protocol, measured using the Vicon 3D motion analysis system.2. Primary Outcome Measure #2: Title: Variability of Kinematic (Angular) Gait Parameters Operational Definition: The degree of fluctuation in the joint angles of the lower limbs (hip, knee, and ankle) in the sagittal plane during the gait cycle, calculated using the Mean Coefficient of Variation (MeanCV). These angles are recorded and analyzed using the Vicon 3D motion analysis system. Timepoint: First Time Point: Baseline assessment (before the start of any intervention or group allocation)Second Time Point: Final assessment (immediately after completing the 8-week Pilates exercise program for the intervention group, and after the same 8-week period for the two control groups). Method of measurement: Measurement Tool: Vicon 3D Motion Capture System equipped with optical cameras and a force plate.Measurement Method: Spatiotemporal and kinematic gait parameters are obtained using this system by placing reflective markers on specific anatomical landmarks and recording the individual's movement while walking on a defined pathway. The raw data is processed, and the variability (CV and MeanCV) of the target parameters is then calculated from multiple gait cycles. Islamic Azad University Approved 2026-01-04 Ethics Committee of Islamic Azad University, Science and Research Branch Tehran, Islamic Azad University, Science and Research Branch Tehran Tehran Iran (Islamic Republic of)