Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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This research was done in Rehabilitation Science Faculty of Ahvaz Medical Science University. Participants, Data Collector and Outcome Assessor were blinded to research.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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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.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2017-12-17, 1396/09/26
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Ahvaz medical science university
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Expected recruitment start date
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2017-12-25, 1396/10/04
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Expected recruitment end date
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2018-07-13, 1397/04/22
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Actual recruitment start date
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2017-12-30, 1396/10/09
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Actual recruitment end date
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2018-07-21, 1397/04/30
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Trial completion date
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2018-07-21, 1397/04/30
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
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Sample size
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Target sample size:
50
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Blocked Randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants
Data Collector
Outcome Assessor
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-02-25, 1395/12/07
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Ethics committee reference number
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IR. ajums .REC.1395.761
Health conditions studied
1
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Description of health condition studied
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Diabetes Mellitus
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ICD-10 code
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ٍٍE10-E14
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ICD-10 code description
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Diabetes Mellitus
Primary outcomes
1
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Description
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Static Balance Status
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Timepoint
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Before Intervention, After Intervention
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Method of measurement
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Force Plate
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Description
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Dynamic Balance Status
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Timepoint
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Before Intervention, After Intervention
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Method of measurement
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Biodex Balance System
3
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Description
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Functional Balance Status
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Timepoint
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Before Intervention, After Intervention
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Method of measurement
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Berg Balance Scale
4
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Description
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Walking Status
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Timepoint
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Before Intervention, After Intervention
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Method of measurement
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10 Meters Walking Test
Secondary outcomes
1
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Description
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Cognitive Status
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Timepoint
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Before Intervention, After Intervention
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Method of measurement
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Trail Making A,B Tests, Forward & Backward Digit Span, Rey Osterrieth Test, Letter & Category Fluency
Intervention groups
1
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Description
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First Interventional Group: Sensory-Motor Exercises incluce Balance Training, Stretching and Strengthening exercises and Electrical Stimulation
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Category
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Rehabilitation
2
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Description
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Second Interventional Group: Sensory-Motor Exercises Adding Dual Task Training include Balance Training, Stretching, Strengthening Exercises and Electrical Stimulation Adding Cognitive-Motor Dual Task
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Ahvaz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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All Data in A SPSS File
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When the data will become available and for how long
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6 Months After Acceptance of Extracted Article
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To whom data/document is available
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Scientific Researchers
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Under which criteria data/document could be used
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Only for Studying Purpose
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From where data/document is obtainable
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Responsive's Email
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What processes are involved for a request to access data/document
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During One Week After Request
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Comments
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