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IRCT20140304016830N12 IRCT 2020-05-27 Iran University of Medical Sciences The effect of occupational therapy interventions on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson's disease A randomized controlled trial to compare the effect of bi-manual activities with and without motivational strategies on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson´s disease 2019-11-06 anticipated 45 Complete https://irct.ir/trial/43846 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients who are included in the study will randomly allocated to one of the following three groups: the control group (A) or bi-manual activities with motivational strategies group (B) or bi-manual activities without motivational strategies group (C). Randomization method is simple randomization and randomization unit is individual. Randomization and creating a random sequence will be done using a web-based randomization system (https://www.graphpad.com/quickcalcs/randMenu/). Group allocation concealment will be done using sequentially numbered sealed envelopes, Blinding description: Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind of the groups allocation. To keep assessors blinded, participants and therapists were instructed not to reveal received intervention or participants’ study experiences to the assessors. Patients are also blind on the groups allocation. To keep patients blind, interventions and evaluation sessions for different groups will be arranged so that participants in different groups will not encounter each other. N/A Parkinson's disease. Intervention 1: Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living). Intervention 2: First intervention group: Bi-manual activities with motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, different motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will be used to enhance an individual's level of motivation during the intervention. Intervention 3: Second intervention group: Bi-manual activities without motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will not be used. 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: One year 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) Having Parkinson's disease according to neurologist diagnosis (based on UK brain Bank criteria for the diagnosis of idiopathic Parkinson's disease) 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 Persian version of Mini Mental State Examination and score greater than 24 on the Persian version of Montreal cognitive assessment questionnaire) Having at least a fifth grade education Ability to perform uni-manual and bi-manual motor tasks Feeling the need or desire to participate in occupations selected for the intervention (bi-manual occupations in the form of activities of daily living, instrumental activities of daily living and playing) 35 years 85 years Both 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 Having pathological dementia according to the neurologist diagnosis Having Juvenile Parkinsonism G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living). First intervention group: Bi-manual activities with motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, different motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will be used to enhance an individual's level of motivation during the intervention. Second intervention group: Bi-manual activities without motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will not be used. Motor control of upper extremity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Motion analysis system. Sensory-motor skills of upper extremity. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Wrist position sense test, Hand active sensation test, Box & Block Test, Grip Dynamo-meter test, Purdue Pegboard Test, Nine Hole Peg Test, Coin Rotation Test. Participation. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Canadian occupational performance measure, Meaningful Activity Participation Assessment Questionnaire. Cognitive function. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Clock Drawing Test, Parkinson's Disease-Cognitive Rating Scale, Trail Making Test, Stroop Test, Quick Dementia Rating Scale, Digit Symbol Test, Benton test. Quality of life. Timepoint: Before and after intervention and 8 weeks after intervention. Method of measurement: Parkinson's Disease Questionnaire (PDQ-39), 36-Item Short Form Health Survey (SF-36). Iran University of Medical Sciences Approved 2019-10-30 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)