the Effect of task - oriented training with altered sensory input in balance of elderly persons
Design
A randomized, blind clinical trial will be conducted with the parallel group plan of 10 elderly people .The study groups consisted of a treatment group and a control group. All tests are performed by one person and testers also patients are blinded to the study groups.
Settings and conduct
The site of this study will be the Neuro-Muscular Rehabilitation Center. According to a sample study, these interventions are performed 3 times a week for 4 weeks, and each session lasts about 1 hour. People receive balance tests and functional mobility 1 week before and 1 week after exercise. All tests are performed by one person and testers and patients are blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having at least 60 years of old
Ability to walk independently and without auxiliary equipment at least 10 meters in length
Having a cognitive performance level above 21 in the MMSE test
Having at least 1 falling in the last 6 months
Not having any neurological or other disease
Exclusion criteria:
Disconnecting the person in the intervention sessions
Absence of referrals for second-stage tests
Not able to complete activities and progress to its harder levels
Intervention groups
Treatment group: A group that uses the protocol designed for equilibrium exercises. These exercises consist of 12 sessions, which are based on two principles of internalization of the body's sense of emotion and individual safety. These treatments sit in 4 positions, siting, sit to stand, standing and walking. Each of these four positions is performed for 10 minutes and is restrained between each state for 30 seconds. Before and after the exercises, warm-up and cool-down exercises each take 5 minutes of muscle stretching.
Control group: A group that only receives current rehabilitation exercises.
Main outcome variables
Balance and functional mobility that will be measured using the Berg Balance Scale and Time Up and Go tests
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180217038762N1
Registration date:2018-03-12, 1396/12/21
Registration timing:registered_while_recruiting
Last update:2018-03-12, 1396/12/21
Update count:0
Registration date
2018-03-12, 1396/12/21
Registrant information
Name
Fatemeh Daneshjoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3332 8502
Email address
FatemehDaneshjoo@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-24, 1396/12/05
Expected recruitment end date
2018-05-21, 1397/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of task – oriented training with altered sensory input on balance in the elderly people
Public title
:The effect of task - oriented training in elderly"
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having at least 60 years of old
Ability to walk independently and without auxiliary equipment at least 10 meters in length
Having a cognitive performance level above 21 in the MMSE test
Having at least 1 incidence in the last 6 months
Not having any neurological or other disease
Exclusion criteria:
Disconnecting the person in the examinations and intervention sessions
Absence of referrals for second-stage tests
Not able to complete activities and progress to its harder levels
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and evaluator will be unaware of how people are categorized into intervention and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Science
Street address
Ghods blvd, Neuromuscular Research Center
City
Semnan
Province
Semnan
Postal code
35196_98375
Approval date
2018-02-05, 1396/11/16
Ethics committee reference number
IR.SEMUMS.REC.1396.216
Health conditions studied
1
Description of health condition studied
Elderly people
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Balance score in the Berg Balance Scale
Timepoint
1 week before and one week after intervention
Method of measurement
Berg Balance Scale
2
Description
Functional mobility score in Time Up and Go test
Timepoint
1 week before and one week after intervention
Method of measurement
Time Up and Go test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Equilibrium Exercise Program consists of 12 sessions of practice, which is based on three principles of inputs of the somatosensory, the difficulty of tasks and individual safety. Each of these four states is performed for 10 minutes and is restrained between each state for 30 seconds.
Category
Rehabilitation
2
Description
Control group: This group uses only common rehabilitation exercises
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Nueromuscular rehabilitation research center
Full name of responsible person
Fatemeh Daneshjoo
Street address
Nueromuscular rehabilitation research center ,Ghods blvd, Semnan
City
Semnan
Province
Semnan
Postal code
35196_98375
Phone
+98 23 3332 8502
Email
FatemehDaneshjoo@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Science, Basij blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Daneshjoo
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Neuromuscular rehabilitation research center ,Ghods blvd. Semnan
City
Semnan
Province
Semnan
Postal code
35196-98357
Phone
+98 23 3332 8502
Email
FatemehDaneshjoo@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Daneshjoo
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Neuromuscular rehabilitation research center, Ghods blvd, Semnan
City
Semnan
Province
Semnan
Postal code
35196-98357
Phone
+98 23 3332 8502
Email
FatemehDaneshjoo@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Daneshjoo
Position
lecturer
Latest degree
Master
Other areas of specialty/work
Occupational Therapy
Street address
Neuromuscular rehabilitation research center, Ghods blvd, Semnan
City
Semnan
Province
Semnan
Postal code
35196-98375
Phone
+98 23 3332 8502
Email
FatemehDaneshjoo@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
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
Title and more details about the data/document
Reproductive in the field of rehabilitation and behavioral science
When the data will become available and for how long
1 years
To whom data/document is available
researchers
Under which criteria data/document could be used
Reproductive in the field of rehabilitation and behavioral science
From where data/document is obtainable
Semnan University of Medical Science
What processes are involved for a request to access data/document
Supervision of the Student Research Committee of Semnan University of Medical Science - Fulfillment of main investigator obligation