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IRCT20140304016830N15 IRCT 2025-07-28 Iran University of Medical Sciences Evaluating the Effect of Mental Practices on the Movement of Adults with Cerebral Palsy Evaluating the Effect of Motor Imaginary Training on Motor Learning of Adults with Cerebral Palsy: the role of anxiety and age 2025-08-23 anticipated 90 Recruiting https://irct.ir/trial/84838 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The type of randomization used in this study is block randomization, which will be performed using the website http://www.randomizer.org by a person independent of the therapist and evaluator. Participants in different groups will have no contact with each other and will receive the interventions on different days. All participants in the three groups will be assessed before the intervention, after the intervention, and at follow-up (two months after the end of the intervention), Blinding description: The participants in this study will be blinded to their group allocation. Although they are aware that they are participating in a research project involving cognitive-practical interventions, they will not be informed about the number of groups, the specific differences between the groups, or the hypotheses of the study. The outcome assessors, data collectors, and the statistician responsible for data analysis will also be blinded to group allocation. The participants and therapists delivering the interventions will also be blinded to the assignments. N/A Spastic cerebral palsy. Intervention 1: Intervention Group 1 (Occupational-Based Group with MIT): Participants in this group will attend a total of 23 sessions. The first session will consist of a data collection session, including clinical and laboratory assessments. The intervention sessions will be held after the initial analysis of variables. The intervention phase will begin in the second session, focusing on physical rehabilitation. This rehabilitation program will include targeted exercises designed to strengthen and stretch the muscles involved in walking. Participants will receive an additional 15 minutes of MIT training at the end of each rehabilitation session. In this section, participants will first select a meaningful scenario of daily activities that they prefer the most. These scenarios will vary in walking speed, stride length, amount of load they carry, and characteristics of the walking path (path width, slope, slippery surface). It is worth noting that all of these scenarios must be imagined and will not be presented in reality. The intervention will last for 20 sessions (2-3 sessions per week) and will end in session 21. Two more data collection sessions will be held after the intervention and after the 2-month follow-up (sessions 22 and 23) at the end of this group's participatory program. Intervention 2: Intervention Group 2 (occupation-based group without MIT): Participants will attend a total of 23 sessions. The first session will consist of a data collection session, including clinical and laboratory assessments. The intervention sessions will be held after the initial analysis of variables. The intervention phase will begin in the second session with a focus on physical rehabilitation. This rehabilitation program will include targeted exercises designed to strengthen and stretch the muscles involved in walking. The intervention will last for 20 sessions (2-3 sessions per week) and will end in session 21. Two more data collection sessions will be held after the intervention and after a 2-month follow-up (sessions 22 and 23) at the end of the group's participatory program. Intervention 3: Control Group: In the healthy control group, they will undergo a data collection session including clinical and laboratory assessments. These data will be used as a baseline for further comparison and analysis. There is no other session regarding data recording and intervention for this group. Yes - There is a plan to make this available What will be shared: The shared file will include de-identified data from study participants. Specifically, the dataset will contain general demographic information (age, gender), group allocation, and scores related to the primary outcome measures of the study. No personal identifiers such as names, contact details, or national ID numbers will be included. Only this specific part of the data will be available to other researchers upon formal request and after obtaining appropriate approvals. The complete dataset or other sensitive information will not be shared. When: One year after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: Researchers working in academic and scientific institutions Where to obtain: Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tel: 00982122227124 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) a diagnosis of spastic CP and no other neurological disorders upon self-declaration of participant having the age of more than 18 years the ability to stand and walk either with or without assistance Not having severe depression the ability to communicate discomfort or pain the comprehension of simple instructions of the tasks during intervention and data collection sessions 18 years no limit Both Any contraindications to participating in the training sessions botulinum toxin (BoTox) injections within six months before the assessment the presence of an intrathecal baclofen pump or any surgical intervention in the past 12 months G80.1 Spastic diplegic cerebral palsy Rehabilitation Rehabilitation Rehabilitation Intervention Group 1 (Occupational-Based Group with MIT): Participants in this group will attend a total of 23 sessions. The first session will consist of a data collection session, including clinical and laboratory assessments. The intervention sessions will be held after the initial analysis of variables. The intervention phase will begin in the second session, focusing on physical rehabilitation. This rehabilitation program will include targeted exercises designed to strengthen and stretch the muscles involved in walking. Participants will receive an additional 15 minutes of MIT training at the end of each rehabilitation session. In this section, participants will first select a meaningful scenario of daily activities that they prefer the most. These scenarios will vary in walking speed, stride length, amount of load they carry, and characteristics of the walking path (path width, slope, slippery surface). It is worth noting that all of these scenarios must be imagined and will not be presented in reality. The intervention will last for 20 sessions (2-3 sessions per week) and will end in session 21. Two more data collection sessions will be held after the intervention and after the 2-month follow-up (sessions 22 and 23) at the end of this group's participatory program. Intervention Group 2 (occupation-based group without MIT): Participants will attend a total of 23 sessions. The first session will consist of a data collection session, including clinical and laboratory assessments. The intervention sessions will be held after the initial analysis of variables. The intervention phase will begin in the second session with a focus on physical rehabilitation. This rehabilitation program will include targeted exercises designed to strengthen and stretch the muscles involved in walking. The intervention will last for 20 sessions (2-3 sessions per week) and will end in session 21. Two more data collection sessions will be held after the intervention and after a 2-month follow-up (sessions 22 and 23) at the end of the group's participatory program. Control Group: In the healthy control group, they will undergo a data collection session including clinical and laboratory assessments. These data will be used as a baseline for further comparison and analysis. There is no other session regarding data recording and intervention for this group. Functional mobility. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: Functional mobility will be assessed through Timed Up and Go (TUG) test to evaluate a person's mobility, balance, walking ability, and fall risk. lower score in this test indicates better performance in movement. Functional balance. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: Berg Balance Scale (BBS). Quality of life. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: World Health Organization Quality of Life questionnaire- Brief version. Gait parameters. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: measuring speed, step length, and step width during walking. Motor imagery ability. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: Chronometer test, and Laterality test. Anxiety level. Timepoint: Baseline, post-intervention (month 2), and follow-up (month 2). Method of measurement: Anxiety subscale of Hospital and Depression Scale (HADS). Private budget Approved 2025-07-15 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences (IUMS), next to Milad Tower, Hemmat Expressway Tehran Tehran Iran (Islamic Republic of)