Protocol summary

Study aim
The aim of this study is to evaluate the effect of eight weeks of dynamic neuromuscular stability training with and without mirrors on motor function, proprioception, and body awareness in patients with Parkinson's disease.
Design
Two-arm parallel group randomised trial with case-by-case matching based on the severity of the disease
Settings and conduct
This study will be conducted at the University of Isfahan under the supervision of a physician and by researcher team. The person analyzing the data will not be aware of the researcher's exact purpose.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Age range 50 to 70 years 2- Patients with Parkinson's disease (Hun and Yar score 3 or less) 3- Voluntary consent to participate in the study 4- No other neurological or musculoskeletal diseases Exclusion criteria: 1- History of surgery or fracture in the lower limbs 2- Participation in physical rehabilitation programs simultaneously with the research 3- Failure to regularly participate in training sessions (five alternating sessions or three consecutive sessions) 4- Failure to complete the research tests 5- Unforeseen circumstances that prevent the patient from participating in the study. 6- Voluntary withdrawal from participation in the study 7- Visible visual impairment
Intervention groups
Both groups in this study will use the 8-week exercise. The intervention group (mirror) will use the mirror, while the control group exercises without a mirror.
Main outcome variables
Measuring motor function, proprioception, and body awareness in patients with Parkinson's disease

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251101067842N1
Registration date: 2025-12-24, 1404/10/03
Registration timing: prospective

Last update: 2025-12-24, 1404/10/03
Update count: 0
Registration date
2025-12-24, 1404/10/03
Registrant information
Name
Mohaddeseh Assari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3778 7963
Email address
assarimohaddeseh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-01-10, 1404/10/20
Expected recruitment end date
2026-01-20, 1404/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Eight-week Dynamic Neuromuscular Stability Training With and Without Mirror Use on Motor Function, Proprioception, and Body Awareness in Patients with Parkinson’s Disease
Public title
The effect of exercise on patients with parkinson's disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range 50 to 70 years2- Patients with Parkinson's disease (Hun and Yar scale score of 3 and below)3- Voluntary consent to participate in the research4- No other neurological or musculoskeletal diseases
Exclusion criteria:
1-History of surgery or fracture in the lower limbs 2- Participation in physical rehabilitation programs simultaneously with the research 3- Failure to regularly participate in training sessions (five alternating sessions or three consecutive sessions) 4- Failure to complete research tests 5- Unforeseen circumstances that prevent the patient from participating in the research 6- Voluntary withdrawal from participation in the research 7- Visible visual impairment
Age
From 50 years old to 70 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
In this study, prior to the initiation of the intervention, it is planned that 30 eligible patients will be recruited using a convenience sampling method (scores 1 to 3 based on the Hoehn and Yahr scale). To control for disease severity, it is planned that after enrollment and before group allocation, patients would be paired based on their Hoehn and Yahr scores. For each pair, random allocation to the mirror or control group was planned using a predefined simple randomization procedure. Specifically, for each pair, a random number would be generated using a random number table. If the generated number was even, the first patient in the pair would be assigned to the experimental group and the second to the control group; if the number was odd, the allocation would be reversed. This predefined process will be applied to all pairs, resulting in two groups of 15 participants with comparable distributions of disease severity.
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
Ethical Committee of Isfahan University
Street address
Building No. 4, Vice President for Research and Technology, Isfahan University of Medical Sciences and Health Services, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-08-26, 1404/06/04
Ethics committee reference number
IR.UI.REC.1404.117

Health conditions studied

1

Description of health condition studied
parkinson disease
ICD-10 code
parkinson
ICD-10 code description
G20

Primary outcomes

1

Description
The effect of exercise protocol on static balance in patients with Parkinson's disease.
Timepoint
Static balance was measured first before the start of training and then after two months of training.
Method of measurement
Sharpend Romberg test

2

Description
Determining the effect of exercise protocol on dynamic balance in patients with Parkinson's disease.
Timepoint
Dynamic balance was measured first before the start of training and then after two months of training.
Method of measurement
Timed up and Go test

3

Description
Determining the effect of an exercise protocol on hand tremor in patients with Parkinson's disease.
Timepoint
Hand tremor was measured first before the start of the exercises and then after two months of training.
Method of measurement
MDS-UPDRS questionnaire

4

Description
Determining the effect of exercise protocol on muscle strength in patients with Parkinson's disease.
Timepoint
Muscle strength was measured first before the start of training and then after two months of training.
Method of measurement
Digital hand-held dynamometer

5

Description
Determining the effect of the exercise protocol on the range of motion of patients with Parkinson's disease.
Timepoint
The patients' range of motion was measured first before starting the exercises and then after two months of training.
Method of measurement
Goniometer

6

Description
Determining the effect of an exercise protocol on the quality of life of patients with Parkinson's disease.
Timepoint
Quality of life was measured first before the start of the exercises and then after two months of training.
Method of measurement
Specific questionnaire on quality of life for patients with Parkinson's disease

7

Description
Determining the effect of an exercise protocol on body awareness in patients with Parkinson's disease.
Timepoint
Body awareness was measured first before the start of the exercises and then after two months of training.
Method of measurement
Motor imagery questionnaire

8

Description
Determining the effect of an exercise protocol on proprioception in patients with Parkinson's disease
Timepoint
Proprioception was measured first before the start of the training and then after two months of training.
Method of measurement
Goniometer

Secondary outcomes

1

Description
Forced Expiratory Volume in 1 Second (FEV1)
Timepoint
At baseline and after the 8-week intervention
Method of measurement
Spirometry

2

Description
Forced vital capacity (FVC)
Timepoint
At baseline and after the 8-week intervention
Method of measurement
Spirometry

3

Description
FEV1FVC1
Timepoint
At baseline and after the 8-week intervention
Method of measurement
Spirometry

Intervention groups

1

Description
Intervention group: Intervention group: After the subjects are selected based on the inclusion and exclusion criteria, the subjects are selected purposefully. Then, they are given explanations about the purpose of the research and how the research will be conducted, and written consent is obtained from the subjects to voluntarily participate in the research. Then, a pre-test is taken on the dependent variables, and the subjects are randomly and pairedly divided into two groups based on the Hon and Yar scale, one group with a mirror and one group without a mirror. Next, the training intervention (dynamic neuromuscular stability exercises) with mirror therapy is applied to the subjects in the experimental groups for eight weeks, 3 sessions per week.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Parkinson Patients Charity
Full name of responsible person
Gholam Ali Ghasemi
Street address
Alley 58 (Payam), Keshavarz Boulevard, Shahid Mofateh Intersection towards Simin Intersection
City
Isfahan
Province
Isfehan
Postal code
8185648491
Phone
+98 31 3776 3834
Email
gh.ghasemi@spr.ui.ac.ir
Web page address
https://sprold.ui.ac.ir/~gh.ghasemi/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Esfahan University of Medical Sciences
Street address
Isfahan, Azadi Square, Isfahan University, Faculty of Sports Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Fax
+98 31 3668 7572
Email
Gh.ghasemi@spr.ui.ac.ir
Web page address
https://sprold.ui.ac.ir/~gh.ghasemi/
Grant name
Vice President for Research, University of Isfahan
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Esfahan University of Medical Sciences
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
Esfahan University of Medical Sciences
Full name of responsible person
Esfahan University of Medical Sciences
Position
university professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Azadi Square, Isfahan University, Faculty of Sports Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
0098 31-3793257
Fax
+98 31 3668 7572
Email
gh.ghasemi@spr.ui.ac.ir
Web page address
https://sprold.ui.ac.ir/~gh.ghasemi/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam Ali Ghasemi
Position
university professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Azadi Square, Isfahan University, Faculty of Sports Sciences
City
isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Fax
+98 31 3668 7572
Email
Gh.ghasemi@spr.ui.ac.ir
Web page address
https://sprold.ui.ac.ir/~gh.ghasemi/

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholam ali ghasemi
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Azadi Square, Isfahan University, Faculty of Sports Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 31 3793 2571
Fax
+98 31 3668 7572
Email
Gh.ghasemi@spr.ui.ac.ir
Web page address
https://sprold.ui.ac.ir/~gh.ghasemi/

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Aggregate data can be shared after individuals are de-identified.
When the data will become available and for how long
Access period starts 6 months after results are published.
To whom data/document is available
Available only to those working in scientific, industrial, and academic institutions.
Under which criteria data/document could be used
reaserchers
From where data/document is obtainable
Email the responsible author.
What processes are involved for a request to access data/document
we will respond them when they send email to us.
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