Assessment of changes in Balance and balance recovery mechanism During manipulation of Vestibular and Somatosensory system and after a period of aquatic exercise and detraining and determine their relation to strength, proprioception and reaction time in blind, deaf and healthy persons
Objective: The purpose of this study is to assess of changes in balance and balance recovery mechanism during manipulation of vestibular and somatosensory system and after a period of aquatic exercise and determine their relation to strength, proprioception and reaction time in blind, deaf and healthy persons. Design: In this clinical trial, 30 healthy persons, 30 blind persons and 30 deaf persons will be divided randomly in two groups of aquatic exercise and control (15 persons of each populations in one group). Setting and conduct: Aquatic exercise groups will participate in training sessions for 8 weeks while the control groups will not receive the intervention. Major inclusion and exclusion criteria: Inclusion criteria include: Age between 27 and 36; no specific sport activity during study. Exclusion criteria from the study include: Congenital disorders; previous surgery or injury especially in lower extremities; use of sedative and analgesic drugs that disrupt proprioception and balance (especially 24 hours before the test); non-normal body mass index; specific diseases; neuromuscular disease; Inability to do pre and post intervention tests; doing effective exercises in order to improving balance and no completion of training sessions. Interventions: Aquatic exercise and manipulation of sensory system. Main outcome variables: Before and after intervention, all subjects will be assessed for postural control, balance recovery strategy, reaction time, strength and proprioception.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017022132705N1
Registration date:2017-07-15, 1396/04/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-15, 1396/04/24
Registrant information
Name
Asma Salari
Name of organization / entity
Shahid Bahonar University
Country
Iran (Islamic Republic of)
Phone
+98 34 3261 0355
Email address
asmasalari@sport.uk.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shahid Bahonar University of Kerman
Expected recruitment start date
2017-01-24, 1395/11/05
Expected recruitment end date
2017-02-23, 1395/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of changes in Balance and balance recovery mechanism During manipulation of Vestibular and Somatosensory system and after a period of aquatic exercise and detraining and determine their relation to strength, proprioception and reaction time in blind, deaf and healthy persons
Public title
Assessment of changes in Balance and balance recovery mechanism after a period of aquatic exercise and detraining in blind, deaf and healthy persons
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria include: Age between 27 and 36; no specific sport activity during study. Exclusion criteria from the study include: Congenital disorders; previous surgery or injury especially in lower extremities; use of sedative and analgesic drugs that disrupt proprioception and balance (especially 24 hours before the test); non-normal body mass index; specific diseases; neuromuscular disease; Inability to do pre and post intervention tests; doing effective exercises in order to improving balance and no completion of training sessions.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Science
Street address
Somayeh Crossroads, Kerman
City
Kerman
Postal code
Approval date
2017-01-23, 1395/11/04
Ethics committee reference number
IR.KMU.REC.1395.351
Health conditions studied
1
Description of health condition studied
Falling (Loss of balance)
ICD-10 code
W01,W10,W1
ICD-10 code description
Fall on same level from slipping, tripping and stumbling,Fall on and from stairs and steps, Other fall from one level to another,Other fall on same level,Unspecified fall,Tendency to fall, not elsewhere classified,Senility
2
Description of health condition studied
Visual impairment
ICD-10 code
H54.0
ICD-10 code description
Blindness, binocular
3
Description of health condition studied
Visual impairment
ICD-10 code
H54.1
ICD-10 code description
Severe visual impairment, binocular
4
Description of health condition studied
Visual impairment
ICD-10 code
H54.2
ICD-10 code description
Moderate visual impairment, binocular
Primary outcomes
1
Description
Postural control
Timepoint
Before, after and one month after intervention
Method of measurement
By Biodex system and Y balance test
2
Description
Balance recovery strategy
Timepoint
Before, after and one month after intervention
Method of measurement
By Motion Analysis System
3
Description
Strength
Timepoint
Before, after and one month after intervention
Method of measurement
By Hand Held Dynamometer
4
Description
Proprioception
Timepoint
Before, after and one month after intervention
Method of measurement
By Photography
5
Description
Reaction Time
Timepoint
Before, after and one month after intervention
Method of measurement
By Motion Analysis System
6
Description
postural sway index
Timepoint
Before, after and one month after intervention
Method of measurement
By foot scan
7
Description
EMG activity of muscles
Timepoint
Before, after and one month after intervention
Method of measurement
By EMG device
Secondary outcomes
empty
Intervention groups
1
Description
Aquatic exercise group will participate in training sessions for 8 weeks and their status will be evaluated Before, after and one month after intervention.
Category
Prevention
2
Description
The control group will not receive the intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Blind Society
Full name of responsible person
Mr Sattari
Street address
gharani Square, Kerman
City
Kerman
2
Recruitment center
Name of recruitment center
Deaf community
Full name of responsible person
Mr Mirzadeh
Street address
Firoozeh Cross Road, , Kerman
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Bahonar University of Kerman