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IRCT20190625044003N1 IRCT 2019-09-12 Iran National Science Foundation The efficiency of articulated ankle-foot orthosis and rocker sole shoe on walking biomechanics in stroke patients The efficiency of articulated ankle-foot orthosis with first and second rockers mechanism and rocker sole shoe on walking biomechanics in patients with hemiplegic stroke: Randomized Clinical Trial 2017-11-22 anticipated 20 Complete https://irct.ir/trial/40392 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Since the sampling method in the present study is consecutive. It means that researcher gets present at the patients' referral site (Dr. Jawad Mowafaghian Research Center for Intelligent NeuroRehabilitation Technologies) from the beginning of the study, and patients who are eligible to participate in the study are identified and then, invited to participate in the study. Therefore, randomization is occurred consecutively. It should be noted that only one rehabilitation center is sampled in this study. In this study, simple randomization method is used and randomization unit is individual. In this way, participants with the odd number assigned to them (By order of referral) are included in the intervention group, and participants with the even number assigned to them are included in the control group. The allocation concealment is that Participants are unaware of the allocation of groups (intervention and control group), Blinding description: Participants (patients) are unaware of the allocation of groups (intervention group and control group). That is, participants are unaware of which group, intervention group, and which group is the control group. N/A cerebrovascular accident (stroke). Intervention 1: Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe). Intervention 2: Control group: Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe). Yes - There is a plan to make this available What will be shared: All above will be published in the article When: After the article publication To whom: After the article publication, people can access Conditions: Other researchers and therapists in the rehabilitation and medical field can use this use the data of this study after the article publication Where to obtain: After the article publication, people can find the article by searching in internet and access the data How to obtain: After the article publication, people can find the article by searching in internet and access the data Comments:
public Aliyeh Daryabor
Address: Kodakyar Ave., Daneshjo Blvd.,Evin,Post code: : 1985713871
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0010 r_daryabor@yahoo.com University of social welfare and rehabilitation sciences scientific Aliyeh Daryabor
Kodakyar Ave., Daneshjo Blvd.,Evin,University of Social Welfare and Rehabilitation Science
Tehran Iran (Islamic Republic of) ۱۹۸۵۷۱۳۸۳۴ +98 21 2218 0010 r_daryabor@yahoo.com University of social welfare and rehabilitation sciences Iran (Islamic Republic of) Age between 40 to 68 Stroke patients should have plantarflexors spasticity at least 2 according to the modified Ashworth scale (MAS) A minimum of 6 months poststroke No involvement in the contralateral limb Able to walk independently Patients should have the passive ability to dorsiflex ankle joint 40 years 68 years Both The presence of hammered toes, Fixed contraction in the ankle, hip and knee joints, Having a history of cardiovascular and pulmonary disease Patients with knee hyperflexion Very poor balance based on TUG test G46.3* Brain stem stroke syndrome Rehabilitation Rehabilitation Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe) Control group: Intervention group: ankle foot orthosis (AFO) with plantar flexion resistance and 2 kind of shoes (standard shoe and rocker shoe) Temporal-spatial parameters (walking speed, step length, stride length, cadence). Timepoint: In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and gait parameters are measure in two condition, without orthosis and with orthosis. Method of measurement: Three-dimensional movement capture system (vicon). Walking Kinematic (sagittal joints angles of ankle, knee and hip, and pelvic 3-dimensional angles in pelvis and thorax). Timepoint: In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and walking Kinematic are measure in two condition, without orthosis and with orthosis. Method of measurement: Three-dimensional movement capture system (vicon). Walking Kinetic (sagittal joints moments of ankle, knee and hip, anterior-posterior ground reaction force). Timepoint: In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and walking Kinetics are measure in two condition, without orthosis and with orthosis. Method of measurement: Kistler forceplate. Fatigue during walking with orthoses. Timepoint: In this study, after fabrication of orthoses for patients, the subjects use the made orthosis for adapting in daily living for 2 weeks. Then, patients refer to gait biomechanics laboratory, and fatigue variable are measure in two condition, without orthosis and with orthosis by the questionnaire. Method of measurement: Questionnaire. Iran National Science Foundation Approved 2016-12-02 Ethics committee of University of Social Welfare and Rehabilitation Science Address: kodakyar Ave., daneshjo Blvd.,Evin,Post code: : 1985713871 tehran Tehran Iran (Islamic Republic of)