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The effect of dual-task exercises on balance, falling and Activities of Daily Living in stroke patients

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History
# Registration date Revision Id
3 2018-05-24, 1397/03/03 46783
2 2018-05-22, 1397/03/01 46482
1 2018-05-20, 1397/02/30 46090
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  • Protocol summary

    A) General purpose: Determining the effect of dual task exercises on balance, fall and independence in performing Activities of Daily Living, fear of falling, anterior functional reach, quality of life and depression in people with stroke. B) Applied Objectives: Providing effective interventions for improving balance, falling, performing Activities of Daily Living, fear of falling, anterior functional reach, quality of life and depression in people with stroke.
    A) General purpose: Determining the effect of dual task exercises on balance, fall and independence in performing Activities of Daily Living in people with stroke. B) Applied Objectives: Providing effective interventions for improving balance, falling and performing Activities of Daily Living in people with stroke.
    الف) هدف كلي: تعیین اثر تمرینات تکلیفی دو‌گانه بر تعادل، افتادن ، استقلال در انجام فعالیت‌های کارکردی روزمره ، ترس از افتادن، دسترسی عملکردی قدامی، کیفیت زندگی و افسردگی در افراد با سکته مغزی. ب) اهداف كاربردي: ارائه مداخلاتی موثر جهت بهبود تعادل، افتادن، انجام فعالیت‌های کارکردی روزمره ، ترس از افتادن، دسترسی عملکردی قدامی، کیفیت زندگی و افسردگی در افراد با سکته مغزی.
    الف) هدف كلي: تعیین اثر تمرینات تکلیفی دو‌گانه بر تعادل، افتادن و استقلال در انجام فعالیت‌های کارکردی روزمره در افراد با سکته مغزی. ب) اهداف كاربردي: ارائه مداخلاتی موثر جهت بهبود تعادل، افتادن و انجام فعالیت‌های کارکردی روزمره در افراد با سکته مغزی.
    Stroke, dual task exercises, balance, fall, Activities of Daily Living, cognition, fear of falling, anterior functional reach test, quality of life, deprresion
    Stroke, dual task exercises, balance, fall and Activities of Daily Living
    سکته مغزی، تمرینات تکلیفی دوگانه، تعادل، افتادن، فعالیت‌های روزمره زندگی، شناخت، ترس از افتادن، دسترسی عملکردی قدامی، کیفیت زندگی، افسردگی
    سکته مغزی، تمرینات تکلیفی دوگانه، تعادل، افتادن و فعالیت‌های روزمره زندگی

  • General information

    The effect of dual-task exercises on balance, falling and Activities of Daily Living, fear of falling, anterior functional reach test, quality of life and depression in stroke patients
    The effect of dual-task exercises on balance, falling and Activities of Daily Living in stroke patients
    بررسی تاثیر تمرینات تکلیفی دوگانه بر تعادل، افتادن و فعالیت‌های کارکردی روزمره، ترس از افتادن، دسترسی عملکردی قدامی، کیفیت زندگی و افسردگی در افراد با سکته مغزی
    بررسی تاثیر تمرینات تکلیفی دوگانه بر تعادل، افتادن و فعالیت‌های کارکردی روزمره در افراد با سکته مغزی
    The effect of dual-task exercises on balance, falling and Activities of Daily Living, fear of falling, anterior functional reach test, quality of life and depression in stroke patients
    The effect of dual-task exercises on balance, falling and Activities of Daily Living in stroke patients
    بررسی تاثیر تمرینات تکلیفی دوگانه بر تعادل، افتادن و فعالیت‌های کارکردی روزمره، ترس از افتادن، دسترسی عملکردی قدامی، کیفیت زندگی و افسردگی در افراد با سکته مغزی
    بررسی تاثیر تمرینات تکلیفی دوگانه بر تعادل، افتادن و فعالیت‌های کارکردی روزمره در افراد با سکته مغزی

  • Primary outcomes

    #1
    fear of falling
    empty
    ترس از افتادن
    empty
    fear of falling measurement at the beginning of the study (before the intervention), 24 days after the start and 60 days after the end of the study
    empty
    اندازه گیری ترس از افتادن در ابتدای مطالعه (قبل از شروع مداخله)، 24 روز پس از شروع و 60 روز پس از پایان مطالعه
    empty
    Persian version of the Fall EfficacyScale-International
    empty
    مقیاس بین المللی ترس از افتادن نسخه فارسی
    empty
    #2
    quality of life
    empty
    کیفیت زندگی
    empty
    quality of life Measurement at the beginning of the study (before the intervention), 24 days after the start and 60 days after the end of the study
    empty
    اندازه گیری کیفیت زندگی در ابتدای مطالعه (قبل از مداخله)، 24 روز پس از شروع و 60 روز پس از پایان مطالعه
    empty
    SF36 quality of life questionnaire
    empty
    پرسشنامه کیفیت زندگی SF36
    empty
    #3
    Depression
    empty
    افسردگی
    empty
    Measurement of depression at the beginning of the study (before intervention), 24 days after the onset and 60 days after the end of the study
    empty
    اندازه گیری افسردگی در ابتدای مطالعه (قبل از مداخله)، 24 روز پس از شروع و 60 روز پس از پایان مطالعه
    empty
    Beck Depression Inventory
    empty
    پرسشنامه افسردگی بک
    empty
    #4
    Anterior Functional Reach Test
    empty
    دسترسی عملکردی قدامی
    empty
    Measurement of Anterior Functional Reach Test at the beginning of the study (before intervention), 24 days after start and 60 days after the end of the study
    empty
    اندازه گیری دسترسی عملکردی قدامی در ابتدای مطالعه (قبل از مداخله)، 24 روز پس از شروع و 60 روز پس از پایان مطالعه
    empty
    Anterior Functional Reach Test
    empty
    اندازه گیری دسترسی عملکردی قدامی
    empty

Protocol summary

Study aim
A) General purpose: Determining the effect of dual task exercises on balance, fall and independence in performing Activities of Daily Living in people with stroke. B) Applied Objectives: Providing effective interventions for improving balance, falling and performing Activities of Daily Living in people with stroke.
Design
randomised, clinical trial with control group, one blinded participant, care provider, outcome assessor and data analyser, designed with 30 patients, enrolled between April 2018 and august 2018 and followed for 2 month.
Settings and conduct
Samples were selected from among patients with stroke referring to Rehabilitation Hospital in rofeideh, Tehran, fromApril 2018 to August 2018
Participants/Inclusion and exclusion criteria
Patients with stroke referring to rofeideh Hospital in Tehran in 1397 if they have criteria for entering the study
Intervention groups
The common rehabilitation exercises in both intervention and control groups for four weeks and six days each week, plus dual cognitive-motor exercises, will be performed in the intervention group during the same period.
Main outcome variables
Stroke, dual task exercises, balance, fall and Activities of Daily Living

General information

Reason for update
Acronym
تاثیر فعالیت های دوگانه بر تعادل
IRCT registration information
IRCT registration number: IRCT20171105037256N4
Registration date: 2018-05-20, 1397/02/30
Registration timing: prospective

Last update: 2018-05-25, 1397/03/04
Update count: 2
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
mojtaba kheirkhah
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
mo.kheirkhah@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-26, 1397/03/05
Expected recruitment end date
2018-09-27, 1397/07/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of dual-task exercises on balance, falling and Activities of Daily Living in stroke patients
Public title
The effect of dual-task exercises on balance, falling and Activities of Daily Living in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of stroke by specialist Age between 20-70 years Ability to understand and follow instructions One year from a stroke A score of more than 22 from the MMSE exam Ability to stand independently The ability to walk 3 meters No hearing impairment based on expert examination No use of any walking aid
Exclusion criteria:
Failure to co-operate with the patient Incidence of symptoms such as seizure, stroke ... which violates the conditions for entry into the study Substance abuse and addictive drugs Any other neurological disease, such as epilepsy, Parkinson's, ... Having any orthopedic disease that causes balance problems
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization, individual, sealed envelope
Blinding (investigator's opinion)
Triple blinded
Blinding description
In this study, Triple blind was used in which the participant, the clinical caregiver and the outcome assessor were unaware of the allocation of patients in the control or intervention group. In this study, doctors and other health care staff referring patients Patients in the intervention or control group are unaware.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
kodakyar Ave,Daneshjo Blvd,Tehran
City
tehran
Province
Tehran
Postal code
kodakyar Ave,Daneshj
Approval date
2017-09-25, 1396/07/03
Ethics committee reference number
IR.USWR.REC.1396.277

Health conditions studied

1

Description of health condition studied
stroke
ICD-10 code
I64
ICD-10 code description
Cerebrovascular accident NOS

Primary outcomes

1

Description
balance
Timepoint
Balance measurement at the beginning of the study (before the intervention), 24 days after the start and 60 days after the end of the study
Method of measurement
berg balance scale

2

Description
falling
Timepoint
falling measurement at the beginning of the study (before the intervention), 24 days after the start and 60 days after the end of the study
Method of measurement
Timed Up and Go Test

3

Description
Activities of Daily Living
Timepoint
Measurement of the ability to perform Activities of Daily Living at the beginning of the study (before the intervention), 24 days after the start and 60 days after the end of the study
Method of measurement
functional independence measure

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Common occupational therapies include muscle stretching, muscle strengthening, muscle coordination, cognitive-motor exercises
Category
Rehabilitation

2

Description
Control group: Common occupational therapies include muscle stretching, muscle strengthening, muscle coordination
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
rofeideh Rehabilitation Hospital
Full name of responsible person
nazila akbarfahimi
Street address
Tehran Province, Tehran, Nemati
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2223 3017
Email
fahimi1970@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Amir Massoud Arab (Loodaricheh)
Street address
kodakyar Ave,Daneshjo Blvd,tehran
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0039
Email
arabloo_masoud@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
mojtaba kheirkhah
Position
researcher, student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave,Daneshjo Blvd,Tehran
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0037
Email
mo.kheirkhah@uswr.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
mojtaba kheirkhah
Position
researcher, student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
kodakyar Ave,Daneshjo Blvd,Tehran
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0037
Email
mo.kheirkhah@uswr.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
mojtaba kheirkhah
Position
researcher, student
Latest degree
Bachelor
Other areas of specialty/work
Occupational Therapy
Street address
depatment of occupational therapy, University of social and welfare rehabilitation sciences kodakyar Ave,Daneshjo Blvd,Tehran,Iran
City
tehran
Province
Tehran
Postal code
۱۹۸۵۷۱۳۸۳۴
Phone
+98 21 2218 0037
Email
mo.kheirkhah@uswr.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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