]>
IRCT20180627040251N13 IRCT 2025-07-29 Kharazmi University "Effect of Strength-Balance Exercises, Virtual Reality, and Combined Exercises on Neuroplasticity, Quality of Life, Balance, and Fall Risk in Parkinson's Disease" Comparison of Strength-Balance Exercises, Virtual Reality-Based Exercises, and Combined Exercises on Neuroplasticity, Quality of Life, Balance, and Fall Risk in Patients with Parkinson's Disease 2025-08-01 anticipated 48 Complete https://irct.ir/trial/84702 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the initial assessment of the participants, randomization was carried out based on four-block randomization. Participants are randomly assigned to one of two groups using four-block randomization. One of the research team members, who is not involved in the sample selection process, determines the random allocation sequence using the online tool (randomizer.org). Sealed opaque envelopes containing the randomization sequence will be used for allocation concealment, Blinding description: In this study, the outcome assessor is blind to the groups’ randomization and interventions receiving by participants. in this way, during the evaluation before and after the intervention protocol, they do not make mistakes in their judgments in favor of a specific therapeutic intervention. N/A Parkinson's Disease. Intervention 1: Group 1 (Strength-Balance Exercises):Participants in this group receive strength and balance exercises three times a week for 8 weeks. The exercises include resistance training using weights to strengthen lower limb muscles and balance exercises such as standing on balance boards and performing dynamic movements to improve coordination and stability. Intervention 2: Intervention group: Group 2 (Virtual Reality-Based Exercises):Participants in this group use virtual reality systems to perform balance and movement exercises. These exercises are designed in simulated virtual environments, and patients perform balance and coordination tasks under the supervision of a physiotherapist. Each session lasts 30 minutes, and the exercises are performed three times a week for 8 weeks. Intervention 3: Intervention group: Intervention Group 3 (Combined Exercises):This group receives a combination of strength-balance exercises and virtual reality-based exercises. Participants perform 30 minutes of strength and balance exercises followed by 30 minutes of virtual reality-based exercises in each session. The sessions are conducted three times a week for 8 weeks. Intervention 4: Control group: Intervention group: Control Group:The control group receives no intervention and only undergoes standard treatment protocols. 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 There is no additional information available
public Aryan Omidi
No. 12, Allameh Jafari St., Tohid Town, Sabzevar County, Razavi Khorasan, Iran
sabzevar Iran (Islamic Republic of) 9617984797 +98 51 4441 0962 aryan.omidi2911@gmail.com kharazmi university scientific Hassan Sadeghi
Faculty of Physical Education and Sports Sciences, Shahid Keshvari Complex, Shahid Hesari St., Mirdamad, Tehran, Iran
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 hassan.sadeghi81@yahoo.com Kharazmi University Iran (Islamic Republic of) Patients diagnosed with Parkinson’s disease confirmed by a specialist doctor. Individuals aged between 50 and 70 years. Patients with moderate to severe symptoms based on the UPDRS-III scale. Individuals capable of performing physical exercises according to the study protocol. Individuals who have signed a written consent form to participate in the study. 50 years 75 years Male Individuals with neurological disorders other than Parkinson’s disease (such as Alzheimer’s or stroke). Individuals with severe psychiatric conditions that impair their ability to participate in exercises. Individuals currently undergoing active or continuous physical therapy. G20 Parkinson's disease Rehabilitation Rehabilitation Rehabilitation Placebo Group 1 (Strength-Balance Exercises):Participants in this group receive strength and balance exercises three times a week for 8 weeks. The exercises include resistance training using weights to strengthen lower limb muscles and balance exercises such as standing on balance boards and performing dynamic movements to improve coordination and stability. Intervention group: Group 2 (Virtual Reality-Based Exercises):Participants in this group use virtual reality systems to perform balance and movement exercises. These exercises are designed in simulated virtual environments, and patients perform balance and coordination tasks under the supervision of a physiotherapist. Each session lasts 30 minutes, and the exercises are performed three times a week for 8 weeks. Intervention group: Intervention Group 3 (Combined Exercises):This group receives a combination of strength-balance exercises and virtual reality-based exercises. Participants perform 30 minutes of strength and balance exercises followed by 30 minutes of virtual reality-based exercises in each session. The sessions are conducted three times a week for 8 weeks. Control group: Intervention group: Control Group:The control group receives no intervention and only undergoes standard treatment protocols. Neuroplasticity. Timepoint: The measurement of outcome variables is conducted at two time points:Before the intervention (Pre-test)After the intervention (Post-test). Method of measurement: Neuroplasticity: Electroencephalogram (EEG). Quality of Life:To assess the quality of life in Parkinson's patients. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: PDQ-39. Balance. Timepoint: mmediately before intervention; immediately after intervention. Method of measurement: -Single Leg Stance Test--TUG test. Fall risk. Timepoint: immediately before intervention; immediately after intervention. Method of measurement: BBS test. Kharazmi University Approved 2025-04-20 Research Ethics Committees of kharazmi university Shahid Keshvari Sports Complex, Kosha Street, between Shohareh and Hesari, Shahid Haghani Highway, Tehran (Mirdamad neighborhood) Tehran Tehran Iran (Islamic Republic of)