Protocol summary

Study aim
The aim of the present study was to determine the effectiveness of two training protocols, DNS and TOCT, in Parkinson's disease.
Design
A simple randomized, non-blinded, parallel-group, controlled clinical trial conducted on 30 patients.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
Balance; motor function; tunk control; quality of life

General information

Reason for update
Acronym
TOCT-DNS-PD
IRCT registration information
IRCT registration number: IRCT20251110067946N1
Registration date: 2026-06-03, 1405/03/13
Registration timing: registered_while_recruiting

Last update: 2026-06-03, 1405/03/13
Update count: 0
Registration date
2026-06-03, 1405/03/13
Registrant information
Name
Marziyeh Ardeshiri lordejani
Name of organization / entity
Shahid Beheshti University Faculty of Sports and Health Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 5847
Email address
ma.ardeshirilordejan@mail.sbu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-05-11, 1405/02/21
Expected recruitment end date
2026-06-29, 1405/04/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Comparison of Two Types of Exercise Training on Balance, Motor Performance, Trunk Control, and Quality of Life in Patients with Parkinson’s Disease
Purpose
Supportive
Inclusion/Exclusion criteria
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.
Age
From 55 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee, Shahid Beheshti University
Street address
Office of the Vice-Chancellor for Research, Shahid Beheshti University, Ovin Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1658953571
Approval date
2025-09-06, 1404/06/15
Ethics committee reference number
IR.SBU.REC.1404.149

Health conditions studied

1

Description of health condition studied
Parkinson
ICD-10 code
G20
ICD-10 code description
Parkinson's disease

Primary outcomes

1

Description
Balance
Timepoint
Balance will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
Method of measurement
Mini-Balance Evaluation Systems Test

2

Description
Motor Function
Timepoint
Motor Function will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
Method of measurement
Timed Up and Go (TUG)

3

Description
Trunk Control
Timepoint
Trunk Control will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
Method of measurement
Trunk Impairment Scale (TIS)

4

Description
Quality of Life
Timepoint
Quality of Life will be assessed at baseline (prior to the intervention) and again following the completion of a six-week training program
Method of measurement
Quality of Life questionnaire (PDQ-39)

Secondary outcomes

empty

Intervention groups

1

Description
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 .
Category
Rehabilitation

2

Description
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 .
Category
Rehabilitation

3

Description
Control group: receive no intervention and continue to live in normal life.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat rasul akram hospital
Full name of responsible person
Marzieh ardeshiri lordejani
Street address
Daneshjo blvd., Shahid Shahriyari sq.,Yemen street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1816
Email
ma.ardeshirilordejan@mail.sbu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice President for Research, Shahid Beheshti University
Full name of responsible person
Amir Hossein Barati
Street address
Shahid Beheshti University, Shahid Shahryari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Email
pr-office@sbu.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President for Research, Shahid Beheshti University
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
The university of shahid beheshti
Full name of responsible person
Marziyeh ardeshiri lordejani
Position
student
Latest degree
Bachelor
Other areas of specialty/work
sport injury and corrective actions
Street address
Shahid Beheshti University, Shahid Shahryari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 913 464 9084
Email
ardeshirineda3@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University Faculty of Sports and Health Sciences
Full name of responsible person
Amir Hossein Barati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Shahid Beheshti University, Shahid Shahryari Square, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 29901
Fax
Email
ahbarati20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University Faculty of Sports and Health Sciences
Full name of responsible person
Marziyeh Ardeshiri lordejani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Sports pathology and corrective movements
Street address
Tehran, Shahid Chamran Highway, Yemen St., Shahid Shahriari Square, Shahid Beheshti University Faculty of Sports Sciences and Sports Rehabilitation
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 913 464 9084
Fax
Email
ma.ardeshirilordejan@mail.sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Loading...