Protocol summary
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Study aim
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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.
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Design
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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.
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Settings and conduct
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Samples were selected from among patients with stroke referring to Rehabilitation Hospital in rofeideh, Tehran, fromApril 2018 to August
2018
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Participants/Inclusion and exclusion criteria
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Patients with stroke referring to rofeideh Hospital in Tehran in 1397 if they have criteria for entering the study
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Intervention groups
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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.
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Main outcome variables
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Stroke, dual task exercises, balance, fall and Activities of Daily Living
General information
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Reason for update
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Acronym
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تاثیر فعالیت های دوگانه بر تعادل
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IRCT registration information
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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
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Registration date
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2018-05-20, 1397/02/30
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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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Expected recruitment start date
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2018-05-26, 1397/03/05
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Expected recruitment end date
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2018-09-27, 1397/07/05
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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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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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 70 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:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization, individual, sealed envelope
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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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.
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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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2017-09-25, 1396/07/03
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Ethics committee reference number
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IR.USWR.REC.1396.277
Health conditions studied
1
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Description of health condition studied
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stroke
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ICD-10 code
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I64
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ICD-10 code description
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Cerebrovascular accident NOS
Primary outcomes
1
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Description
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balance
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Timepoint
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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
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Method of measurement
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berg balance scale
2
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Description
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falling
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Timepoint
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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
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Method of measurement
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Timed Up and Go Test
3
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Description
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Activities of Daily Living
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Timepoint
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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
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Method of measurement
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functional independence measure
Intervention groups
1
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Description
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Intervention group: Common occupational therapies include muscle stretching, muscle strengthening, muscle coordination, cognitive-motor exercises
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Category
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Rehabilitation
2
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Description
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Control group: Common occupational therapies include muscle stretching, muscle strengthening, muscle coordination
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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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University of social welfare and rehabilitation 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Undecided - It is not yet known if there will be 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