To investigate the effect of 10 weeks of proprioceptive exercises on proprioceptive accuracy and balance in Parkinson's patients
Design
The clinical trial has an intervention group of 12 Parkinson's patients with H&Y 2-3 in the form of pre- and post-assessment without blinding.
Settings and conduct
After entering the study, the participants sign the informed consent form approved by Tarbiat Modares University. They will then fill out a personal information and medical history form. Before the intervention, the quality of life questionnaire will be completed by the participants. Then, pre-intervention assessments will be done. Patients will perform 20 sessions of proprioceptive exercises in the movement disorders research laboratory for 10 weeks, twice a week for 30 minutes each time. The evaluations after the intervention will be done exactly like the previous evaluations and up to one week after the last intervention session. The location of the study is the Movement Disorders Research Laboratory in Tarbiat Modares University.
Participants/Inclusion and exclusion criteria
Patients with Parkinson's disease; with H&Y criteria 2-3; aged 35 to 65 years; able to move without assistance
Intervention groups
One group including therapeutic exercise group (proprioceptive exercises)
Main outcome variables
The acuity of sense of motion and sense of the position of the ankle joint in the anterior-posterior direction in functional and non-functional tasks; balance parameters; quality of life questionnaire score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230516058210N1
Registration date:2023-05-23, 1402/03/02
Registration timing:prospective
Last update:2023-05-23, 1402/03/02
Update count:0
Registration date
2023-05-23, 1402/03/02
Registrant information
Name
Mahrokh Taheri
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 26 3670 6773
Email address
mahrokh.taheri@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-12-09, 1402/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 10-week Proprioceptive Exercises on Proprioception Acuity, Balance, and Quality of Life in Patients with Parkinson’s Disease
Public title
Effect of Proprioception Exercises on Balance in Patients with Parkinson’s Disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with idiopathic Parkinson's disease diagnosed by a neurologist according to the UK Brain Bank Criteria
H&Y criteria between 2-3
Obtaining a minimum score of 24 in the MMSE questionnaire
Able to walk without assistance
Be able to perform simple verbal commands
The age of the participants should be 35 to 65
Having a body mass index between 18.5-30
Exclusion criteria:
Specific musculoskeletal, cardiorespiratory, vision, or cognitive disorder that affects the patient's performance of tests and exercises and walking
Having diabetes
Having a neurological problem other than Parkinson's disease
Undergoing DBS surgery
Participating in regular exercise therapy programs in the last 6 months
Using walking aids
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Jalal Al Ahmad Street, Nasr Bridge, No. 7, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2023-04-30, 1402/02/10
Ethics committee reference number
IR.MODARES.REC.1402.008
Health conditions studied
1
Description of health condition studied
Parkinson's disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Ankle joint proprioceptive acuity (sense of position and sense of motion)
Timepoint
Before the start of the intervention and up to one week after the end of the 10-week intervention
Method of measurement
Using a customized designed and manufactured device (angular and time error between expressed and real values)
2
Description
Postural control parameters
Timepoint
Before the start of the intervention and up to one week after the end of the 10-week intervention
Method of measurement
With force platform and chronometer
3
Description
Parkinson's disease questionnaire of quality of life (PDQ-39)
Timepoint
Before the start of the intervention and up to one week after the end of the 10-week intervention
Method of measurement
Score of questionnaire of quality of life PDQ-39
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 weeks of proprioceptive exercises which are designed as stations in 11 different stations and each training station lasts for 2 minutes, the total duration of the exercises will be 30 minutes, including warm-up exercises. Parkinson's patients will perform 20 sessions of proprioceptive exercises in the Movement Disorders Research Laboratory for 10 weeks, twice a week for 30 minutes each time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Mohammad Najafi Ashtiani
Street address
Jalal Al Ahmad Street, Nasr Bridge, No. 7, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5054
Email
mahrokh.taheri@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research assistant of Tarbiat Modares University
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, No. 7, Jalal Al Ahmad Street, Tehran
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 2009
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research assistant of Tarbiat Modares 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
Tarbiat Modares University
Full name of responsible person
Mahrokh Taheri
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad Street, Nasr Bridge, No. 7, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5054
Email
mahrokh.taheri@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Najafi Ashtiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanic
Street address
Jalal Al Ahmad, Nasr Bridge, No. 7, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5054
Email
mnajafi1987@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mahrokh Taheri
Position
Physiotherapy Master's student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad Street, Nasr Bridge, No. 7, Tarbiat Modares University
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5054
Email
mahrokh.taheri@modares.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All analyzed data will be shared. These data include the evaluations before and after the intervention as well as the final processed data of proprioceptive accuracy and balance variables and the quality of life questionnaire.
When the data will become available and for how long
For 6 months after the official publication of the results
To whom data/document is available
All researchers in the academy and the clinic
Under which criteria data/document could be used
For clinical use only in therapy, neuromusculoskeletal simulations, and rehabilitation equipment design
From where data/document is obtainable
Contact the corresponding author of the articles by email, phone or postal address
What processes are involved for a request to access data/document
Process: 1. Accurately specifying the desired data 2. Contacting the responsible author and submitting the request 3. Reviewing the request by the research team 4. Responding to the request up to 10 working days