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IRCT20260131068709N1 IRCT 2026-05-30 Iran University of Medical Sciences Analyzing the effect of Ankle Foot orthosis adjustment on gait of stroke patients The effect of ankle foot orthosis tuning using wedges on lower limb joint coordination, gait kinematics and Shank-to-Vertical Angle in stroke individuals 2024-07-22 anticipated 25 Complete https://irct.ir/trial/88867 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A stroke. Intervention group: In order to make an Solid ankle-foot orthosis, a mold will be taken of the affected foot in a semi-weight-bearing position. The Solid ankle-foot orthosis is custom-made with the following features: 5 mm propylene sheet, 90-degree angle at the ankle, one centimeter cut line in front of the ankles, and two Velcro straps added horizontally to the proximal orthosis and opposite the ankles at a 45-degree angle. In each condition, heel heights are adjusted from 0 to 25 mm. There are a total of 7 assessment positions.. 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 Since making decisions regarding the release of information requires numerous considerations and complete coordination with the research team, general conclusions have not yet been made, so the final decision to release will be made after an informed decision.
public Mahtab Bagheri
No10,Tadayyon Alley, Shariati Avenue
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2272 6458 mahtabbagheri140@gmail.com Iran University of Medical Sciences scientific Mohammad Ali Sanjari
Faculty of Rehabilitation Sciences, Iran University of Medical Sciences, Shah Nazari Street, Mirdamad, Madar Square,
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 8051 sanjarima@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of ischemic hemiplegic stroke At least 6 months have elapsed since the onset of stroke Ability to stand and walk independently without assistance or the use of a cane Modified Ashworth Scale score of 2 or less at the ankle joint Age between 40 and 66 years History of only one stroke episode Motor function of the lower extremities at Brunnstrom recovery stage 5 or higher Motor function of the upper extremities at Brunnstrom recovery stage 4 or higher Walking ability based on the Functional Ambulation Category (FAC) score of 4 or higher 40 years 66 years Both Use of medications that may interfere with walking and balance. Structural limb length discrepancy between the lower extremitie Uncontrolled diabetes mellitus or uncontrolled hypertension Uncorrected visual or hearing impairments Bilateral involvement resulting from stroke Presence of any neuromuscular or neurological disorders, such as Parkinson’s disease, cerebellar disorders, or vestibular disorders Presence of cognitive impairment Unilateral neglect 164 Stroke, not specified as haemorrhage or infarction Rehabilitation Intervention group: In order to make an Solid ankle-foot orthosis, a mold will be taken of the affected foot in a semi-weight-bearing position. The Solid ankle-foot orthosis is custom-made with the following features: 5 mm propylene sheet, 90-degree angle at the ankle, one centimeter cut line in front of the ankles, and two Velcro straps added horizontally to the proximal orthosis and opposite the ankles at a 45-degree angle. In each condition, heel heights are adjusted from 0 to 25 mm. There are a total of 7 assessment positions. Primary outcome:Intra-limb coordination pattern between the thigh and shank during gait without an ankle-foot orthosis and under seven heel height conditions of the ankle-foot orthosis in individuals with hemiparetic stroke (instantaneous measurements). Timepoint: Outcome measurements will be conducted in a single session and performed immediately. Assessment under each study condition (different orthotic conditions) will be carried out immediately after applying the respective condition. Method of measurement: In this study, a Qualisys Motion Capture (QMC) motion capture analyzer with five cameras will be used to calculate joint kinematics, shank to vertical angle, and the Thigh-Shank segment coordination pattern. Time to complete the Time Up and Go (TUG) test without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately). Timepoint: Outcome measurements will be conducted in a single session and performed immediately. Assessment under each study condition (different orthotic conditions) will be carried out immediately after applying the respective condition. Method of measurement: Time Up and Go test: Total time from the command to rise from the chair, walk 3 meters, turn 180°, return, and sit back down until full buttock contact with the chair is measured using a stopwatch (in seconds). Distance covered during the 2-Minute Walk Test without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately). Timepoint: The aforementioned study outcome will be measured in a single session and in real time. Evaluation under each investigated condition (different orthotic conditions) will be performed immediately after applying that specific condition. Method of measurement: 2-Minute Walk test: Distance covered over the entire 2-minute interval is measured using a stopwatch, from the start signal until exactly 2 minutes have elapsed. Shank-to-vertical angle during walking without an ankle-foot orthosis and under seven ankle-foot orthosis heel-height conditions in individuals with hemiplegic stroke (measured immediately). Timepoint: The aforementioned study outcome will be measured in a single session and in real time. Evaluation under each investigated condition (different orthotic conditions) will be performed immediately after applying that specific condition. Method of measurement: Shank-to-vertical angle: Angle relative to the vertical axis during stance phase, specifically at mid-stance, measured using reflective markers on the shank and 3D motion analysis system. Iran University of Medical Sciences Approved 2024-04-22 Research Ethics Working Group/Committee, Iran University of Medical Sciences Hemmat Highway, next to Milad Tower, Iran University of Medical Sciences, Central Headquarters Building, Vice President for Research and Technology Tehran Tehran Iran (Islamic Republic of)