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IRCT20260817070688N1 IRCT 2026-08-20 University of Isfahan The effect of body-weight-supported treadmill training Effect of an Eight-Week Combined Protocol (Body Weight-Supported Treadmill Training) on Weight Bearing, Motor Function, Respiratory Function, and Quality of Life in Patients with Incomplete Paraplegic Spinal Cord Injury 2026-08-23 anticipated 30 Recruiting https://irct.ir/trial/92590 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants are assigned to two groups an intervention group (weight-supported treadmill training) and a control group (non-treadmill training)using a paired randomization method based on the ASIA scale and the Randomizer.org software. This approach maintains balance between the groups and minimizes selection bias. N/A People with incomplete spinal cord injury. Intervention 1: Intervention group: Participants undergo an eight-week program consisting of three sessions per week; each 45-minute session involves weight-supported treadmill walking and upper-limb exercises performed under the supervision of a therapist. The training regimen is progressively adjusted according to the individuals' capabilities, and all exercises are standardized for every patient and conducted under the supervision of the researcher. Intervention 2: Control group: All study participants perform a range of exercises—including balance, endurance, and strength training, but excluding treadmill walking—three times a week for eight weeks, with each session lasting 45 minutes; all exercises are conducted under the supervision of a therapist. 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 Lack of further information
public Fatemeh Taheri
No. 16, Ettehad Alley, Shohada Street, Imam Khomeini Street
Isfahan Iran (Islamic Republic of) 8195641790 +98 31 3580 3822 f.taheri79@spr.ui.ac.ir The University of Isfahan scientific Dr.Gholamali Ghasemi
Faculty of Sports Sciences,University of Isfahan,Azadi Square,Isfahan
Isfahan Iran (Islamic Republic of) 8174673441 +98 31 3793 2128 gh.ghasemi@spr.ui.ac.ir The University of Isfahan Iran (Islamic Republic of) Patients with spinal cord injury (incomplete paraplegia), based on specialist diagnosis and the ASIA assessment. Age range of 20 to 50 years Presence of sensation and movement in the lower limbs Voluntary consent to participate in the study Walking with an assistive device such as a brace 20 years 50 years Both Vestibular and coordination disorders Suffering from any metabolic, organic, or similar disease—excluding spinal cord injury. Occurrence of any unforeseen problem that makes the patient's participation in the study impossible. Voluntary withdrawal from participation in the research Irregular attendance at training sessions Pregnancy S34 Injury of lumbar and sacral spinal cord and nerves at abdomen, lower back and pelvis level Rehabilitation Rehabilitation Intervention group: Participants undergo an eight-week program consisting of three sessions per week; each 45-minute session involves weight-supported treadmill walking and upper-limb exercises performed under the supervision of a therapist. The training regimen is progressively adjusted according to the individuals' capabilities, and all exercises are standardized for every patient and conducted under the supervision of the researcher. Control group: All study participants perform a range of exercises—including balance, endurance, and strength training, but excluding treadmill walking—three times a week for eight weeks, with each session lasting 45 minutes; all exercises are conducted under the supervision of a therapist. The maximum functional reach distance in the modified MFRT, measured in centimeters. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Modified Functional Reach Test. The flexor strength of the hip and knee muscles is measured using a dynamometer and expressed in Newtons. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Dynamometer Device. Hip and knee extensor muscle strength, measured in Newtons using a dynamometer. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Dynamometer device. Core muscle endurance is based on the duration for which a modified plank position is maintained, measured in seconds. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Modified Plank Test. Forced expiratory volume in the first second (FEV1) is measured in liters using a digital spirometer. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Digital spirometry device. Forced Vital Capacity (FVC) is measured by digital spirometry and expressed in liters. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Digital spirometry device. The wheelchair skills test, which is conducted based on the researcher's objective assessment of wheelchair skills and supplemented by a questionnaire. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: wheelchair skills test. Measuring the amount of weight-bearing on the leg during treadmill walking and the precise amount of weight transferred to the weight-support device. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Load cell. Energy expenditure is determined through measurement tests based on distance covered, walking time, and heart rate. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Physiological Cost Index. Walking speed measured in meters per second based on tests conducted over a designated course using an assistive device is expressed in meters per second. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: 10-Meter walk test. The quality of life index score, based on the quality of life index questionnaire. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the eight-week intervention (post-test). Method of measurement: Quality of Life Index. The score on the quality of life questionnaire, which is measured in the pre-test and post-test. Timepoint: Measurements were taken at two time points: before the start of the intervention (pre-test) and immediately after the completion of the 8-week intervention (post-test). Method of measurement: 66-Item Quality of Life Index Questionnaire: 33 Questions on Importance and 33 Questions on Satisfaction. University of Isfahan Approved 2026-06-27 Ethics committee of the University of Isfahan No. 16, Ettehad Alley, Shohada Street, Imam Khomeini Street Isfahan Isfehan Iran (Islamic Republic of)