Investigating the effect of upper extremity game play in the form of "Tele_Rehabilitation" on upper limb sensory-motor function of people with idiopathic Parkinson.
Investigating the effect of upper extremity game play activities in the form of "Tele_Rehabilitation" on upper limb sensory- motor function of people with idiopathic Parkinson's disease
Design
The type of study will be experimental and clinical trial. Patients will be selected as simple or non-probable cases with inclusion criteria. Participants will then be randomly divided into three groups: One group receives upper extremity game play activities in the form of "Tele-Rehabilitation" in clinic. The other group will do the same upper extremity game play in the form of "Tele-Rehabilitation" at home (These two groups also have traditional exercises). The control group only receives occupational therapy traditional exercises in the clinic.
All three groups participant will be assessed before and after doing interventions and also will be followed up after two months.
Settings and conduct
The type of study will be experimental and clinical trial. Patients are referred to clinics and hospitals affiliated to Iran University of Medical Sciences.
Patients are selected as simple or non-probable cases with inclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria of participant:
- People with Parkinson's disease on a scale of 1 to 4 on Hoehn&Yahr Scale;
- level of cognitive performance above 21;
- No orthopedic problem;
Intervention groups
- Intervention group based on upper extremity game play activities with "Tele-Rehabilitation" in the clinic, (with traditional exercise), - Intervention group based on upper extremity game play activities with "Tele-Rehabilitation" at home(with traditional exercise), - Control group by using of occupational therapy traditional exercises in the clinic
Main outcome variables
Wrist Position Sense Test, Shoulder Position Sense Test, Hand Active Sensation Test, Motor function of upper extremity, Power grip
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140416017301N8
Registration date:2020-02-20, 1398/12/01
Registration timing:registered_while_recruiting
Last update:2020-02-20, 1398/12/01
Update count:0
Registration date
2020-02-20, 1398/12/01
Registrant information
Name
Akram Azad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 2450
Email address
azad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of upper extremity game play in the form of "Tele_Rehabilitation" on upper limb sensory-motor function of people with idiopathic Parkinson.
Public title
Comparison of the effect of using of "Tele_Rehabilitation" and "Traditional methods" on Upper limb Sensory-Motor Function of people with idiopathic Parkinson
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with idiopathic Parkinson's disease on a scale of 1 to 4 on Hoehn & Yahr Scale
Level of cognitive performance equal or above 21
Exclusion criteria:
having orthopedic problem
Age
From 35 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
After finding patients as cases in hand or simple non probable which have inclusion criteria people as absolute random( envelope sealed method) will be divided into three groups. All 3 groups participants will be received traditional treatment. In the other two groups, in addition to traditional treatment of the third group, they receive a treatment (Tele-rehab) in two different ways (with and without the therapist).
In absolute random method (envelope and paper method), the name of group s will be written on a piece of paper and put in an envelope and the participants will be asked to choose one of the papers randomly then the patient will be placed in the chosen group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants are blind (in each 3 groups will be done traditional exercises) and the outcome assessor is also blind (Participants at a specific day without knowledge of each other's treatment referred to a center where the outcome assessor would be solely responsible for taking tests from patients without knowledge of the interventions and related participants).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Etics committee of Iran University of Medical Sciences
Street address
Mirdamad Blvd., Modar Sq., Shah-Nazare St., School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1545913187
Approval date
2019-10-30, 1398/08/08
Ethics committee reference number
IR.IUMS.REC.1398.790
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
Sensory_ Motor Function in Upper Limb
Timepoint
Before intervention, after intervention , follow up after 2 month of intervention
Method of measurement
Wrist Position Sense Test, Shouder Position Sense Test, Hand Active Sensation Test, Box-Block Test, Purde-Peg Board Test, Coin Rotation Test, Nine hole Peg Test, Grip Dynamometer
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before intervention, after intervention, follow up 2 month after intervention
Method of measurement
Parkinson Disease Questionnaire
Intervention groups
1
Description
Intervention group- based on upper extremity game play activities with "Tele-Rehabilitation" in clinic: In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week, for 24 sessions and everyone 1:15 minutes with presence of occupational therapist. Also occupational therapy traditional exercises include such as stretching, twisting, postural control and coordination will be done in each session.
Category
Rehabilitation
2
Description
Intervention group- Intervention group based on upper extremity game play activities with "Tele-Rehabilitation" at home: In this group, upper extremity exercise will be done with virtual reality technology in motor pattern needed for Parkinson diseases. Interventions will be done three days a week, for 24 sessions and everyone 1:15 minutes without presence of occupational therapist and also occupational therapy traditional exercises such as stretching, twisting, postural control and coordination will be done. Before starting these sessions patients will come to clinic for training and familiarizing with exercises and doing test before intervention.
Category
Rehabilitation
3
Description
Control group- Occupational therapy traditional exercise: This exercises will be done for one and half hour and include such as stretching, twisting, postural control and coordination.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Rehabilitation clinic, Shafa-Yahyaian Hospital
Full name of responsible person
Akram Azad
Street address
Shahnazari Ave., Moder Square,. Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
azad.a@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Street address
Mirdamad Blvd., Modar Sq., Shahnazari Ave., School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
10
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
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad Blv., Modar Sq., Shahnazari Ave., School of Rehabilitation
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
azad.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad Ave, Modar Blvd, Nazari St, School of Rehabilition
City
Tehran
Province
Tehran
Postal code
154513187
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
azad.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Akram Azad
Position
Associat Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
Mirdamad St., Mirdamad Blvd., Shahnazari St., School of Rehabilition
City
Tehran
Province
Tehran
Postal code
158754391
Phone
+98 21 2222 8051
Fax
+98 21 2222 0946
Email
azad.a@iums.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