A randomized controlled trial to compare the effect of bi-manual activities with and without motivational strategies on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson´s disease
The aim of this study is to compare the effect of bi-manual activities with and without motivational strategies on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson´s disease.
Design
This study is a double-blinded controlled randomized trial with parallel groups. Forty-five patients with Parkinson's disease will participate in this study and they will be randomly assigned to three groups: control group, bi-manual activities with motivational strategies group and bi-manual activities without motivational strategies group. Randomization will be performed by the person who is not involved in the study using random numbers table.
Settings and conduct
This study will be performed in Djavad Mowafaghian of Neuro-Rehabilitation Research Center. Control group receives conventional rehabilitation. Bi-manual activities groups receive 24 sessions of intervention in the form of bi-manual activities (3 sessions/week, 90 min/session) with or without motivational strategies in addition to conventional rehabilitation. Assessors and patients are blinded to the groups allocation.
Participants/Inclusion and exclusion criteria
In this clinical trial study, 45 patients with idiopathic Parkinson's disease will participate. The main inclusion criteria include having Parkinson's disease according to the neurologist diagnosis, having the disease's progression level of 1 to 3 according to Hoehn and Yahr Scale, and an acceptable level of cognitive function. Subjects are excluded in the case of co-morbid other neurological diseases and orthopedic disorders; or having Juvenile Parkinsonism.
Intervention groups
Control group; Bi-manual activities with motivational strategies group; Bi-manual activities without motivational strategies group
Main outcome variables
Participation; Motor control and sensory-motor skills of upper extremity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140304016830N12
Registration date:2020-05-27, 1399/03/07
Registration timing:registered_while_recruiting
Last update:2020-05-27, 1399/03/07
Update count:0
Registration date
2020-05-27, 1399/03/07
Registrant information
Name
Ghorban Taghizadeh
Name of organization / entity
Faculty of Rehabilitation Sciences, Iran University of Medical
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7124
Email address
taghizadeh.gh@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2020-07-05, 1399/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A randomized controlled trial to compare the effect of bi-manual activities with and without motivational strategies on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson´s disease
Public title
The effect of occupational therapy interventions on participation, motor control and sensory-motor skills of upper extremity in subjects with Parkinson's disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Parkinson's disease according to neurologist diagnosis (based on UK brain Bank criteria for the diagnosis of idiopathic Parkinson's disease)
Having the disease's progression level of 1 to 3 according to Hoehn and Yahr Scale
Having an acceptable level of cognitive function (i.e. score equal to or greater than 24 on the Persian version of Mini Mental State Examination and score greater than 24 on the Persian version of Montreal cognitive assessment questionnaire)
Having at least a fifth grade education
Ability to perform uni-manual and bi-manual motor tasks
Feeling the need or desire to participate in occupations selected for the intervention (bi-manual occupations in the form of activities of daily living, instrumental activities of daily living and playing)
Exclusion criteria:
Co-morbid other neurological diseases, orthopedic disorders (such as low back pain and arthritis), diabetes or addiction according to the report of the patient, or patient's family or physician
Having pathological dementia according to the neurologist diagnosis
Having Juvenile Parkinsonism
Age
From 35 years old to 85 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
The patients who are included in the study will randomly allocated to one of the following three groups: the control group (A) or bi-manual activities with motivational strategies group (B) or bi-manual activities without motivational strategies group (C). Randomization method is simple randomization and randomization unit is individual. Randomization and creating a random sequence will be done using a web-based randomization system (https://www.graphpad.com/quickcalcs/randMenu/). Group allocation concealment will be done using sequentially numbered sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Evaluation of the primary and secondary outcomes is performed by experienced individuals who are blind of the groups allocation. To keep assessors blinded, participants and therapists were instructed not to reveal received intervention or participants’ study experiences to the assessors. Patients are also blind on the groups allocation. To keep patients blind, interventions and evaluation sessions for different groups will be arranged so that participants in different groups will not encounter each other.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-10-30, 1398/08/08
Ethics committee reference number
IR.IUMS.REC.1398.794
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
Motor control of upper extremity
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Motion analysis system
2
Description
Sensory-motor skills of upper extremity
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Wrist position sense test, Hand active sensation test, Box & Block Test, Grip Dynamo-meter test, Purdue Pegboard Test, Nine Hole Peg Test, Coin Rotation Test
3
Description
Participation
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Canadian occupational performance measure, Meaningful Activity Participation Assessment Questionnaire
Secondary outcomes
1
Description
Cognitive function
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Clock Drawing Test, Parkinson's Disease-Cognitive Rating Scale, Trail Making Test, Stroop Test, Quick Dementia Rating Scale, Digit Symbol Test, Benton test
2
Description
Quality of life
Timepoint
Before and after intervention and 8 weeks after intervention
Method of measurement
Parkinson's Disease Questionnaire (PDQ-39), 36-Item Short Form Health Survey (SF-36)
Intervention groups
1
Description
Control group: receives conventional rehabilitation (including exercises for upper and lower limb stretching, range of motion and activities of daily living).
Category
Rehabilitation
2
Description
First intervention group: Bi-manual activities with motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, different motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will be used to enhance an individual's level of motivation during the intervention.
Category
Rehabilitation
3
Description
Second intervention group: Bi-manual activities without motivational strategies group that receives 24 sessions of intervention (8 weeks, 3 sessions per week, 90 minutes per session) in the form of bi-manual activities including activities of daily living, instrumental activities of daily living and playing in addition to the conventional rehabilitation. In this group, motivational strategies (such as affirming the patient to facilitate a sense of usefulness, helping to gain a sense of fun by facilitating the likelihood of success, giving appropriate positive feedback to increase patient's awareness of his/her abilities to perform the activity, showing positive changes in patient's performance during intervention sessions and explain the importance of the activity to the individual and how it affects his/her daily life) will not be used.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation centers and hospitals in Tehran
Full name of responsible person
Ghorban Taghizadeh
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for research of Iran University of Medical Sciences, Dr. Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
motevalian.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
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
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ghorban Taghizadeh
Position
ََAssistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 2222 7124
Email
taghizadeh.gh@iums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After the completion of this study, a manuscript regarding the documentation and the results of the study will be prepared and published. If more details are needed, individuals can send their request by email to the person responsible for scientific accountability.
When the data will become available and for how long
One year after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use of the documentation is permitted upon written permission.
From where data/document is obtainable
Ghorban Taghizadeh Adsress: Iran University of Medical Sciences, Shahid Hemmat Highway, Tehranو Tel: 00982122227124و E-mail: taghizadeh.gh@iums.ac.ir
What processes are involved for a request to access data/document
Just sending a request by email and mentioning the explanation about the cause of the need for documentation is enough.