Clinical trial of Evaluation of effectiveness comprehensive protocol spinal muscle training with and without functional electrical stimulation on angle of kyphosis and quality of life in elderly with functional of kyphosis
Objectives:the aim of this study was randomized controlled trial of effectiveness comprehensive protocol spinal muscle training with and without functional electrical stimulation in elderly with functional of kyphosis.
Design: pre- post intervention.
Setting and conduct: participants evaluated before and after 8 weeks of intervention.Single blind is related to participants.
Participants including major: 45 women with functional hyperkyphosis age above the 60 years.
Interventions: 8 weeks corrective exercises and functional electrical stimulation
Main outcome measure: degree of thoracic kyphosis; function; gait speed; quality of life.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060634351N1
Registration date:2017-06-29, 1396/04/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-29, 1396/04/08
Registrant information
Name
Neda Shariatinia
Name of organization / entity
Kharazmi university
Country
Iran (Islamic Republic of)
Phone
+98 21 8832 9220
Email address
std_neda_shariatinya@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of Evaluation of effectiveness comprehensive protocol spinal muscle training with and without functional electrical stimulation on angle of kyphosis and quality of life in elderly with functional of kyphosis
Public title
Comprehension of exercises and electrical stimulation on elderly hyperkyphosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: elderly women equal to and above 60 years old with functional Hayprkyphosis angle equal to or greater than 40 degrees; the participants do not took part in any other treatment.
Exclusion criteria: No advanced disease and acute neuromuscular; orthopedic and neurologic; limb fractures; structural defects and cardiovascular diseases; No more than three falling in the past year (self-report); Do not use narcotic drugs (self-report); Lack of total knee replacement or hip (reported via physician); lack of hip fracture in the last six months (reported via physician); Not taking glucocorticoid medications for at least 3 months in the previous year (reported by the physician); surgery on the trunk and lower extremities; lasting damage in the lower limbs; and influence the research process; such as degenerative changes in the knee and lower limb visible malalignment included (Geneva Valgvm, genu varum, Geneva Rkvrvatvm, pes cavus and planus).
Age
From 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Simple randomization-random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kharazmi university
Street address
Faculty of physical education; south razan; mirdamad;tehran
City
Tehran
Postal code
Iran
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
14442
Health conditions studied
1
Description of health condition studied
Hyperkyphosis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Angle of kyphosis; gait speed; quality of life
Timepoint
Before and after eight weeks intervention
Method of measurement
Angle of kyphosis(cobb angle); function(7 item test); gait speed(six meter walk test); quality of life(questionnaire)
Secondary outcomes
1
Description
Quality of life; Gait of speed
Timepoint
Before and after eight weeks
Method of measurement
Questionaries
Intervention groups
1
Description
1st intervention group: corrective exercises training
2nd intervention group: Functional Electrical Stimulation along with training
Control group: without intervention
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati physiotherapy clinic
Full name of responsible person
Neda shariatinia
Street address
No 1;perofessor hesabi blvd;safaeieh;yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Neda shariatinia
Street address
Faculty of physical education;kharazmi university;Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Azad mohammadi
Position
Phd
Other areas of specialty/work
Street address
Tehran international pardis campus;faculty of physical education;kharazmi university;tehran
City
Tehran
Postal code
Iran
Phone
+98 21 8832 9220
Fax
Email
azad_mohammadi89@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Amir letafatkar
Position
Assistant professor
Other areas of specialty/work
Street address
Tehran international pardis campus;faculty of physical education;kharazmi universitytehran
City
Tehran
Postal code
Iran
Phone
+98 21 2224 8084
Fax
Email
letafatkaramir@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kharazmi university
Full name of responsible person
Neda shariatinya
Position
Phd
Other areas of specialty/work
Street address
Tehran international pardis campus;faculty of physical education;kharazmi university;tehran
City
Tehran
Postal code
Iran
Phone
+98 21 8832 9220
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)