Protocol summary

Summary
This study was planed to evaluate compare between two therapeutic exercise on the clinical balance indices in patients with diabetes type 2 associated with neuropathy.It is a double blinded clinical trial study.60 diabetic neuropathy type 2 with the age of 40-65 that had 18-30 body mass index should have the score of more than two in Michigan neuropathy test,classified into three group(each group contain 20 patient) with accident blocking method.Exclusion criteria: lower extremity complication such as fracture and dislocation at least during 6 months ago and cardio-vascular problems. one group do Frenkel exercise and another group ball training exercise and there was a control group besides.during of each sessions is 55 min daily 5 times a weak in 3 weaks.the clinical balance indices are measured before and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201307142391N13
Registration date: 2014-05-08, 1393/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-08, 1393/02/18
Registrant information
Name
Zahra Rojhani Shirazi
Name of organization / entity
Shiraz University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 1552
Email address
rojhaniz@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-05-22, 1393/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two type of therapeutic exercise Frenkel vs. Swiss ball on the clinical balance indices in patients with diabetes type 2 associated with neuropathy
Public title
The effect of therapeutic exercise in diabetic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: diabetic neuropathy type 2 referred from physician ; between 40-65 years old ; with18-30 body mass index should have the score f more than two in Michigan neuropathy test.Exclusion criteria: lower extremity complications such as fracture and dislocation at least during six months ago ; any history of surgical operations in muscles,bones and joints of lower extremity ; pain in ankle and knee joint during test ; musculo-skeletal disorders such as rheumatoid and myopathy ; middle ear and vestibular impairments in the patient self report ; knee joint flextion contracture ; using supportive equipments in gait ; stop intervention more than two days any way ; cardiovascular problems and hypertension.
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Science
Street address
Shiraz faculty Rehabilitatin,Abyverdy Street,Chamrac Boulvard
City
Shiraz
Postal code
Approval date
2014-04-14, 1393/01/25
Ethics committee reference number
93/17350

Health conditions studied

1

Description of health condition studied
Diabete type2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Balance
Timepoint
Before intervention,one day after intervantion
Method of measurement
Berg Balance Scale Test,Star excursion Test,time of leg stance

Secondary outcomes

empty

Intervention groups

1

Description
intervention group 1,Swiss ball training: balance training in sitting position: 1- holding balance position on ball 2- holding balance position on ball with active movements of one sided upper extremity 3- holding balance position on ball with active movements of two sided upper extremity 4- holding balance position on ball with trunk movements (bending forward and rotation) 5- holding balance position on ball with heel raising 6- holding balance position on ball with toes raising 7- holding balance position on ball with raising heel and toes simultaneous 8- resistance against perturbation 9- weight shifting on ball ball training in standing position: 1- picking up and down the ball with two upper extremity in a straight line 2- picking up and down the ball with two upper extremity in an oblique line 3- moving the ball forward and backward with left and right lower extremity 4- moving the ball in lateral sides with left and right lower extremity 5- throwing ball toward the wall with hand 6- throwing ball toward the wall with foot
Category
Other

2

Description
control group: clinical balance indices is measured without intervention
Category
N/A

3

Description
intervention group 2,Frenkel exercise: in supine position: 1- patient bends one leg at the hip and knee, as heel along the bed,Repeats with the other leg 2- Bends one leg at the hip and knee and Then straights his hip and knee to return to the starting position. Repeats with the other leg 3- Bends one leg with the heel raises from the bed. Repeats with the other leg 4- Bends one leg and place it at the at any point of command. Repeats with the other leg 5- Bends one leg and places that heel on the opposite knee Then slides her heel down the shin to the ankle and back up to his knee and Returns to the starting position.repeats with the other leg 6- Bends both legs and then keeps his ankles together Straighten both legs to return to starting position 7- Bend one leg in a bicycling motion in sitting position: 1- raises the heel Then progress to alternately lifts the entire foot and placing the foot on the floor upon a traced foot print 2- Alternately glides the foot over the marked cross forward, backward and lateral side 3- at first rises from the chair, at second bends trunk forward then rises the trunk and Reverses the procedure to sit down in standing position: 1- shifts the weight to the left foot and places the right foot 12 inches to the right and Repeats exercise with the left side 2- Walks forward between two parallel line 14 inches apart placing 3- Walks forward placing each foot on a footprint traced on the floor( Foot prints is parallel and 2 inches from a center line) 4- Turns to the right and places at the right toe and rotates the right and places right foot on the floor then rotates the right,repeats to the left 5- Walks up and down the stairs and Places the right foot on one step and brings the left up beside it.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Rehabilitation Sciences,Physiotherapy Clinic
Full name of responsible person
Zahra Rojhani Shirazi
Street address
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Seid Basir Hashemi
Street address
Shiraz,Zand Street,Shiraz University of Medical Sciences,University of Centeral Building
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Shiraz University of Medical Sciences
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
Shiraz University Of Medical Science
Full name of responsible person
Zahra Rojhani Shirazi
Position
Phd
Other areas of specialty/work
Street address
Shiraz Faculty Rehabilitation,Street Abyverdy,Chamran Boulvard
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz faculty of rehabilitation
Full name of responsible person
Zahra Rojhani Shirazi
Position
Phd
Other areas of specialty/work
Street address
Faculty Of Rehabilitation,Srtreet Abyverdy,Chamran Boulvard
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
rojhaniz@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Zahra Rojhani Shirazi
Position
Phd
Other areas of specialty/work
Street address
Faculty of Rehabilitation,Street Abyverdy,Chamran Boulvard
City
Shiraz
Postal code
Phone
+98 71 1627 1552
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...