]>
IRCT20140304016830N11 IRCT 2019-12-08 Iran University of Medical Sciences The effect of rehabilitation exercises on upper extremity function and eye movements in people with Parkinson's disease A randomized controlled trial to compare the effect of competitive and non-competitive non linear pedagogy exercises (playful exercises in the form of volleyball) on sensory and motor function of upper extremity and eye movements in people with Parkinson’s disease 2018-11-06 anticipated 48 Complete https://irct.ir/trial/43832 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who were included in the study will randomly allocated to one of the following three groups: control group or competitive playful ball exercises group or noncompetitive playful ball exercises group. Randomization will be conducted by an individual who is not involved in the study using sealed envelopes method. A letter indicating the intervention group is placed in a sealed opaque envelope and the envelopes will kept in the randomized order in a container. For each patient, one envelope will be randomly drawn from the container and the intervention group of that patients will be determined based on a letter in the envelope, Blinding description: Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind on the groups allocation. N/A Parkinson's disease. Intervention 1: Control group: receives conventional rehabilitation. Intervention 2: ّFirst Intervention group: Group receiving competitive playful ball exercises that receives 24 sessions of playful ball exercises in the form of volleyball in a competitive non-linear pedagogy way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. To induce competition in competitive group, exercises are associated with scoring. Intervention 3: Second Intervention group: Group receiving non-competitive playful ball exercises that receives 24 sessions of playful ball exercises in the form of volleyball in a non-competitive non-linear pedagogy way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. There is not any scoring during exercises in the non-competitive group. Yes - There is a plan to make this available What will be shared: After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published. If more details are needed, individuals can send their request by email to the person responsible for scientific accountability. When: 8 months after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: Use of the documentation is permitted upon written permission. Where to obtain: Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir How to obtain: Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough. Comments:
public Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences scientific Ghorban Taghizadeh
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 2222 7124 taghizadeh.gh@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Age between 35 to 75 years Having Parkinson's disease according to the neurologist diagnosis (based on UK brain Bank criteria for the diagnosis of idiopathic PD) Having the disease's progression level of 1 to 3 according to Hoehn and Yahr Scale Having an acceptable level of cognitive function, i.e. score equal to or greater than 24 on the Mini Mental State Examination Having the ability to walk at least 10 meters independently and without assistive device Having at least a fifth grade education 35 years 75 years Both Having pathological dementia according to the neurologist diagnosis Having Juvenile Parkinsonism Co-morbid other neurological diseases, orthopedic disorders (such as low back pain and arthritis), diabetes or addiction according to the report of the patient, or patient's family or physician G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation Control group: receives conventional rehabilitation. ّFirst Intervention group: Group receiving competitive playful ball exercises that receives 24 sessions of playful ball exercises in the form of volleyball in a competitive non-linear pedagogy way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. To induce competition in competitive group, exercises are associated with scoring. Second Intervention group: Group receiving non-competitive playful ball exercises that receives 24 sessions of playful ball exercises in the form of volleyball in a non-competitive non-linear pedagogy way (8 weeks, 3 sessions per week, 90 minutes per session) in addition to the conventional rehabilitation. There is not any scoring during exercises in the non-competitive group. Motor function of upper extremity including motor-control related parameters extracted from recorded data by motion analysis system (e.g. peak velocity, movement time, etc). Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Motion analysis system. Motor function of upper extremity including gross manual dexterity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Box & Block Test. Eye movements parameters (including saccade latency, peak velocity and amplitude). Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Eye tracking system. Sensory function of upper extremity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Wrist Position Sense Test, Two Point Discrimination Test, Hand Active Sensation Test. Cognitive function. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Parkinson's Disease-Cognitive Rating Scale, Trail Making Test, Stroop Test, Digit Symbol Test, Benton test. Levels of Activities of Daily Living. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Barthel Index, Lawton Instrumental Activities of Daily Living Scale. Motor function of upper extremity including fine manual dexterity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Purdue Pegboard Test, Nine Hole Peg Test, Coin Rotation Test. Hand grip power. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Grip Dynamo-meter test. Manual ability level. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: ABILHAND Questionnaire, DASH Questionnaire. Iran University of Medical Sciences Approved 2018-10-28 کمیته اخلاق دانشگاه علوم پزشکی ایران Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)