Protocol summary
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Study aim
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The aim of the present study was to determine the effectiveness of two training protocols, DNS and TOCT, in Parkinson's disease.
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Design
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A simple randomized, non-blinded, parallel-group, controlled clinical trial conducted on 30 patients.
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Settings and conduct
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The current study is conducted on Parkinson's patients at Hazrat Rasool Akram Hospital for 6 weeks, 3 sessions per week, each session lasting 60 minutes.
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Participants/Inclusion and exclusion criteria
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1. Diagnosis of Parkinson's disease with gait disturbance 2. Age 55 to 75 years
3. Being in stage 3 of the disease according to the Hoenn and Yahr scale 4. Not dependent on assistive devices 5. No history of stroke, peripheral neuropathy 6. Normal range of body mass index (18-25.5) 7. Completion of the informed consent form
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Intervention groups
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Ther research design will consist of three groups (two training groups and one control group) participating in 3 training sessions per week for 6 weeks. Dynamic neuromuscular stabilization training group: 5 minutes of warm-up, 50 minutes of core training (with varied movement patterns and breathing control), and 5 minutes of cool-down. Rest between sets: 60 to 150 seconds. Task-based circuit training group: 60 minutes of training at workstations related to daily activities (balance, walking, reaching for objects). This design will be implemented with a pre-test and post-test method.
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Main outcome variables
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Balance; motor function; tunk control; quality of life
General information
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Reason for update
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Acronym
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TOCT-DNS-PD
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IRCT registration information
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IRCT registration number:
IRCT20251110067946N1
Registration date:
2026-06-03, 1405/03/13
Registration timing:
registered_while_recruiting
Last update:
2026-09-05, 1405/06/14
Update count:
1
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Registration date
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2026-06-03, 1405/03/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2026-05-11, 1405/02/21
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Expected recruitment end date
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2026-06-29, 1405/04/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparing the effects of task-oriented circuit training (TOCT) and dynamic neuromuscular stabilization training (DNS) on balance, motor function, trunk control, and quality of life in people with Parkinson's disease: A randomized clinical trial
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Public title
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Comparison of Two Types of Exercise Training on Balance, Motor Performance, Trunk Control, and Quality of Life in Patients with Parkinson’s Disease
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of Parkinson’s disease based on official clinical diagnostic criteria, accompanied by gait impairment.
Age range: 55 to 75 years.
Hoehn and Yahr stage III of Parkinson’s disease.
Independence from assistive devices, with the ability to walk without using a cane or walker.
Absence of stroke, peripheral neuropathy, and other serious diseases that could affect the study outcomes.
Normal body mass index (BMI) ranging from 18.5 to 25.
Completion of the informed consent form and willingness to participate in the study.
Exclusion criteria:
Absence from more than three sessions of the scheduled training program.
Withdrawal of consent or unwillingness to continue participation in the study.
Exacerbation of Parkinson’s disease symptoms.
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Age
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From 55 years old to 75 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Participants who met the inclusion criteria were randomly assigned to one of three groups: TOCT, DNS, or control. Randomization was performed using a simple allocation method, with individual participants as the unit of randomization. To maintain allocation concealment, sealed and coded paper envelopes were used. Each envelope contained the group assignment and was opened sequentially according to the order of participant enrollment to prevent prior allocation.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-09-06, 1404/06/15
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Ethics committee reference number
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IR.SBU.REC.1404.149
Health conditions studied
1
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Description of health condition studied
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Parkinson
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ICD-10 code
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G20
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ICD-10 code description
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Parkinson's disease
Primary outcomes
1
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Description
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Balance
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Timepoint
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Balance will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
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Method of measurement
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Mini-Balance Evaluation Systems Test
2
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Description
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Motor Function
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Timepoint
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Motor Function will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
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Method of measurement
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Timed Up and Go (TUG)
3
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Description
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Trunk Control
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Timepoint
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Trunk Control will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
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Method of measurement
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Trunk Impairment Scale (TIS)
4
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Description
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Quality of Life
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Timepoint
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Quality of Life will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
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Method of measurement
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Quality of Life questionnaire (PDQ-39)
Intervention groups
1
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Description
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the first intervention group : dynamic neuromuscular stabilization exercises 3 times per week for 6 weeks , each training session consisted of three main parts : warm - up for 5 min , dynamic muscle - dynamic stabilization for 50 min and chilling for 5 min . sets of rest intervals between sets are between 60 and 150 seconds . the exercises consist of various motor patterns performed in different situations and exercises with the control of breathing are performed .
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Category
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Rehabilitation
2
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Description
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the second intervention group : وظیفهمحوربیماران - based training program : parkinson " s disease , 3 sessions per week for 6 weeks before starting the training program , 5 min before the start of training program , and in the last 50 minutes , they had their سردکردن in their training program . these include repeating tasks , in order to achieve and maintain the motor learning of these tasks .
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Category
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Rehabilitation
3
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Description
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Control group: receive no intervention and continue to live in normal life.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice President for Research, Shahid Beheshti University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable