Effects of 10-week exercise therapy in transverse plane at home on postural stability and initiation of gait in patients with Parkinson’s disease: a clinical trial
Evaluation of the effect of 10 weeks of cross-plate home therapy on postural stability and gait of Parkinson's patients
Design
A clinical trial with a control group, with parallel, single-blind, randomized groups on 32 patients
Settings and conduct
The tests are performed before and after the training intervention at Tarbiat Modares University, and the interventions will be performed at the patient care center, which will be controlled by a physiotherapist, often virtually. This is a single-blinded study for the data collectors and outcome assessors.
Participants/Inclusion and exclusion criteria
Idiopathic Parkinson's Patients' H & Y criteria should be between 2-3
Have the ability to walk without assistance
Take a fixed dose of medicine
Be able to perform simple verbal commands
The age of the participants is 40 to 75
Have no specific disorder
No diabetes
No body mass index of 35 or more
Have not had surgery or a regular exercise program in the last 6 months
Intervention groups
Intervention group: transverse plane exercise therapy group plus common exercise therapy for Parkinson's patients
Control group: Common exercise therapy group
Main outcome variables
Linear and nonlinear stability metrics based on the excursion of the center of foot pressure (CoP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210516051322N1
Registration date:2021-07-25, 1400/05/03
Registration timing:prospective
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Amir Dodangeh
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6668 0199
Email address
amirdodangeh76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-06, 1400/05/15
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of 10-week exercise therapy in transverse plane at home on postural stability and initiation of gait in patients with Parkinson’s disease: a clinical trial
Public title
Effects of rotational exercises on the stability of patients with Parkinson’s disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female patients with Parkinson's disease diagnosed by a specialist
h&y criterion score between 2 and 3
able to walk without assistance
Be treated with a fixed dose of dopaminergic drugs during the evaluation and exercise therapy and re-evaluation process
able to perform simple verbal commands
The age of the participants is 40 to 75
Exclusion criteria:
Existence of a specific musculoskeletal, cardiorespiratory, balance, visual, or cognitive disorder that exercises affect the patient's gait
Having diabetes
any neurological problem other than Parkinson's
DBS surgery in the last 6 months
Participating in regular exercise therapy programs for the past 6 months
Use of walking aids
body mass index of 35 or more
Age
From 40 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Having entered the patients in accordance with the inclusion criteria, concealed envelopes containing an equal sample size number of exercise or control statements will be provided to an uninformed person, such as a laboratory expert. He chooses one of the envelopes and thus the patient is placed in one of the two groups of control or exercise (intervention) in a simple and individual way. The result will be hidden only from the participating patient and the researchers are aware.
Blinding (investigator's opinion)
Single blinded
Blinding description
Those responsible for data collection and those assessing the outcome are kept blind to the intervention groups. This is done by assigning neutral codes to the participants (without giving information about patients' intervention grouping like S12).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University Ethics Committee
Street address
Jalal AleAhmad., Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IR.MODARES.REC.1400.098
Health conditions studied
1
Description of health condition studied
Parkinson Disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
Linear and nonlinear metrics of stability based on the excursion of the center of foot pressure (CoP)
Timepoint
Before the intervention and immediately after the intervention(10 weeks after start)
Method of measurement
Force Plate system
2
Description
Parkinson's disease quality of life questionnaire PDQ39
Timepoint
Before the intervention and immediately after the intervention(10 weeks after start)
Method of measurement
questionnaire score using 5-point Likert scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Horizontal plane exercise with common exercises.5 exercises that include body rotation exercises are added to the usual exercises. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week.
Category
Rehabilitation
2
Description
Control group: Common exercise therapy. Each movement is performed at the beginning of the training sessions in two sets of ten. Between each set, the patient rests for 1 minute and once every two weeks, according to the physiotherapist, the number of exercises is increased by 20%. Exercises are done for 10 weeks and 3 days every week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat modares university
Full name of responsible person
Mohammed Najafi Ashtiani
Street address
Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5052
Email
amirdodangeh76@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tarbiat Modares University
Full name of responsible person
Yaghob Fatollahi
Street address
Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
fatolahi@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 Deputy 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
Amir Dodangeh
Position
Master of Physiotherapy Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5052
Email
amirdodangeh76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammed Najafi Ashtiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Biomechanics
Street address
Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5052
Email
mnajafi1987@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Dodangeh
Position
Master of Physiotherapy Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal AleAhmad Nasr
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5052
Email
amirdodangeh76@gmail.com
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 processed and analyzed data will be released. These data include the questionnaire scores and linear and nonlinear outcomes of the stability, before and after the interventions.
When the data will become available and for how long
from 6 months after the official publication of results
To whom data/document is available
All academic and clinical researchers
Under which criteria data/document could be used
Only for therapeutical applications, use in neuro-musculoskeletal simulations, and designing rehabilitation assistive devices
From where data/document is obtainable
By contacting the corresponding author of the published papers by email, phone or postal address
What processes are involved for a request to access data/document
Process: 1. Determining the data of interest by the applicant
2. contacting the corresponding author to submit the queries by the applicant
3. Reviewing the queries by the research team
4. Responding to the queries till 10 working days by the research team