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Investigating the Effect of Adding Dual Task Motor-Cognitive Training to Sensory-Motor Exercise, on Postural Stability and Gait in Older Adults with diabetic Peripheral Neuropathy

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History
# Registration date Revision Id
2 2019-07-02, 1398/04/11 95829
1 2017-12-17, 1396/09/26 30074
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  • Protocol summary

    In this research, 56 older adults with Diabetic Peripheral Neuropathy referring to Diabetes Association were chosen purposefully and a code was allocated to each one of them. Then patients were randomly divided into two sensory-motor exercise and sensory-motor with cognitive dual-task exercise.
    In this research, 50 older adults with Diabetic Peripheral Neuropathy referring to Diabetes Association were chosen purposefully and a code was allocated to each one of them. Then patients were randomly divided into two sensory-motor exercise and sensory-motor with cognitive dual-task exercise.
    در این مطالعه 56 سالمند مبتلا به نوروپاتی محیطی دیابتی که دارای شرایط ورود هستند و به انجمن دیابت مراجعه می کنند، انتخاب می شوند. شرکت کنندگان بصورت تصادفی به دو گروه تمرینات حسی-حرکتی و ترکیب تمرینات حسی-حرکتی با تمرینات تکلیف دوگانه شناختی تقسیم شده و به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.
    در این مطالعه 50 سالمند مبتلا به نوروپاتی محیطی دیابتی که دارای شرایط ورود هستند و به انجمن دیابت مراجعه می کنند، انتخاب می شوند. شرکت کنندگان بصورت تصادفی به دو گروه تمرینات حسی-حرکتی و ترکیب تمرینات حسی-حرکتی با تمرینات تکلیف دوگانه شناختی تقسیم شده و به هر یک از شرکت کنندگان یک کد اختصاص داده می شود.

  • General information

    1
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    56
    50
    No
    No
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    40
    2017-04-21, 1396/02/01
    2017-12-25, 1396/10/04
    2018-03-20, 1396/12/29
    2018-07-13, 1397/04/22
    empty
    2017-12-30, 1396/10/09
    empty
    2018-07-21, 1397/04/30
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    2018-07-21, 1397/04/30
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  • Recruitment centers

    #1
    Name of recruitment center - English: Musculoskeletal Rehabilitation Research Center, ahvaz university of medical sciences
    Name of recruitment center - Persian: مرکز تحقیقات توانبخشی عضلانی - اسکلتی، دانشگاه علوم پزشکی اهواز
    Full name of responsible person - English: Solmaz Rezaie
    Full name of responsible person - Persian: سلماز رضایی
    Street address - English: Musculoskeletal Rehabilitation Research Center, ahvaz university of medical sciences
    Street address - Persian: گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز، مرکز تحقیقات توانبخشی عضلانی - اسکلتی
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61354 87534
    Phone: +98 61 3374 3101
    Fax:
    Email: Rezaie.so@ajums.ac.ir
    Web page address:
    Name of recruitment center - English: Musculoskeletal Rehabilitation Research Center, Ahvaz University of Medical Sciences
    Name of recruitment center - Persian: مرکز تحقیقات توانبخشی عضلانی - اسکلتی، دانشگاه علوم پزشکی اهواز
    Full name of responsible person - English: Solmaz Rezaie
    Full name of responsible person - Persian: سلماز رضایی
    Street address - English: Musculoskeletal Rehabilitation Research Center, Ahvaz University of Medical Sciences, Golestan Blvd
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز، مرکز تحقیقات توانبخشی عضلانی - اسکلتی
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61354 87534
    Phone: +98 61 3374 3101
    Fax:
    Email: Rezaie.so@ajums.ac.ir
    Web page address:

  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Behzad Sharif Zadeh
    Full name of responsible person - Persian: دکتر بهزاد شریف مخمل زاده
    Street address - English: ahvaz university of medical sciences
    Street address - Persian: گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز، معاونت توسعه پژوهش و فناوری
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61534 87345
    Phone: +98 61 3336 1984
    Fax:
    Email: Rezaie.so@ajums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Dr. Behzad Sharif Zadeh
    Full name of responsible person - Persian: دکتر بهزاد شریف مخمل زاده
    Street address - English: Ahvaz University of Medical Sciences,Golestan Blvd
    Street address - Persian: بلوار گلستان، دانشگاه علوم پزشکی جندی شاپور اهواز، معاونت توسعه پژوهش و فناوری
    City - English: Ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 61534 87345
    Phone: +98 61 3336 1984
    Fax:
    Email: Rezaie.so@ajums.ac.ir
    Web page address:

Protocol summary

Study aim
Investigating the Effects of Adding Cognitive Dual-Task Training to Sensory-Motor Exercises on Postural Stability and Gait in Older Adults with Diabetic Peripheral Neuropathy
Design
In this research, 50 older adults with Diabetic Peripheral Neuropathy referring to Diabetes Association were chosen purposefully and a code was allocated to each one of them. Then patients were randomly divided into two sensory-motor exercise and sensory-motor with cognitive dual-task exercise.
Settings and conduct
This research was done in Rehabilitation Science Faculty of Ahvaz Medical Science University. Participants, Data Collector and Outcome Assessor were blinded to research.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Diabetes Mellitus Type 1 & 2; Diabetic Peripheral Neuropathy; Age above 50 Years; BMI < 30; Disease Duration>3 Years; MMSE> 24 Exclusion Criteria: Foot Sore in Assessment Moment; Non Corrective Visual & Vestibular Impairments; Use of Assisstive Device; Neurologic & Muscular or Rheumatoid Disease without Relation to Diabetes that Affect Gait and Balance Ability; Partial or Complete Amputation; Use of Drugs that Affect Negatively on Cognition and Consciousness
Intervention groups
Duration of intervention is 8 weeks and every other day. In both groups, same sensory-motor exercises were done but in second group, cognitive dual-task were added.
Main outcome variables
Measurement devices are Force Plate for static balance; Biodex Balance System for dynamic balance;Bberg Balance Scale for functional balance and 10 Meter Walking Test for gait assessment. Patients assess before and after intervention and just single and dual task.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160710028865N1
Registration date: 2017-12-17, 1396/09/26
Registration timing: prospective

Last update: 2019-07-06, 1398/04/15
Update count: 1
Registration date
2017-12-17, 1396/09/26
Registrant information
Name
solmaz rezaie
Name of organization / entity
rehabilitation research center
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3101
Email address
rezaie.so@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz medical science university
Expected recruitment start date
2017-12-25, 1396/10/04
Expected recruitment end date
2018-07-13, 1397/04/22
Actual recruitment start date
2017-12-30, 1396/10/09
Actual recruitment end date
2018-07-21, 1397/04/30
Trial completion date
2018-07-21, 1397/04/30
Scientific title
Investigating the Effect of Adding Dual Task Motor-Cognitive Training to Sensory-Motor Exercise, on Postural Stability and Gait in Older Adults with diabetic Peripheral Neuropathy
Public title
Investigating the Effect of Adding Dual Task Motor-Cognitive Training to Sensory-Motor Exercise, on Postural Stability and Gait in Older Adults with Diabetic Peripheral Neuropathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes Mellitus Type 1 & 2 Diabetic Peripheral Neuropathy Age above 50 Years BMI < 30 Disease Duration>3 Years MMSE> 24
Exclusion criteria:
Foot Sore in Assessment Moment Non Corrective Visual & Vestibular Impairments Use of Assisstive Device Neurologic & Muscular or Rheumatoid Diseases without Relation to Diabetes that Affect Gait and Balance Ability Partial or Complete Amputation Use of Drugs that Affect Negatively on Cognition and Consciousness
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 50
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked Randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants Data Collector Outcome Assessor
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of ahvaz University of Medical Sciences
Street address
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61354 54387
Approval date
2017-02-25, 1395/12/07
Ethics committee reference number
IR. ajums .REC.1395.761

Health conditions studied

1

Description of health condition studied
Diabetes Mellitus
ICD-10 code
ٍٍE10-E14
ICD-10 code description
Diabetes Mellitus

Primary outcomes

1

Description
Static Balance Status
Timepoint
Before Intervention, After Intervention
Method of measurement
Force Plate

2

Description
Dynamic Balance Status
Timepoint
Before Intervention, After Intervention
Method of measurement
Biodex Balance System

3

Description
Functional Balance Status
Timepoint
Before Intervention, After Intervention
Method of measurement
Berg Balance Scale

4

Description
Walking Status
Timepoint
Before Intervention, After Intervention
Method of measurement
10 Meters Walking Test

Secondary outcomes

1

Description
Cognitive Status
Timepoint
Before Intervention, After Intervention
Method of measurement
Trail Making A,B Tests, Forward & Backward Digit Span, Rey Osterrieth Test, Letter & Category Fluency

Intervention groups

1

Description
First Interventional Group: Sensory-Motor Exercises incluce Balance Training, Stretching and Strengthening exercises and Electrical Stimulation
Category
Rehabilitation

2

Description
Second Interventional Group: Sensory-Motor Exercises Adding Dual Task Training include Balance Training, Stretching, Strengthening Exercises and Electrical Stimulation Adding Cognitive-Motor Dual Task
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center, Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Street address
Musculoskeletal Rehabilitation Research Center, Ahvaz University of Medical Sciences, Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61354 87534
Phone
+98 61 3374 3101
Email
Rezaie.so@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Zadeh
Street address
Ahvaz University of Medical Sciences,Golestan Blvd
City
Ahvaz
Province
Khouzestan
Postal code
61534 87345
Phone
+98 61 3336 1984
Email
Rezaie.so@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Science Faculty, In Front of MRI Center, University City
City
Ahvaz
Province
Khouzestan
Postal code
61543 87345
Phone
+98 61 3374 3102
Fax
Email
Rezaie.so@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Science Faculty, In Front of MRI Center, University City
City
Aahvaz
Province
Khouzestan
Postal code
61534 87345
Phone
+98 61 3374 3102
Fax
Email
Rezaie.so@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Solmaz Rezaie
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Sciences Faculty, In Front of MRI Center, University City
City
Ahvaz
Province
Khouzestan
Postal code
61534 87345
Phone
+98 61 3374 3102
Fax
Email
Rezaie.so@ajums.ac.ir
Web page address

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
No - There is not 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
All Data in A SPSS File
When the data will become available and for how long
6 Months After Acceptance of Extracted Article
To whom data/document is available
Scientific Researchers
Under which criteria data/document could be used
Only for Studying Purpose
From where data/document is obtainable
Responsive's Email
What processes are involved for a request to access data/document
During One Week After Request
Comments
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