This study will be done on a subject with Diabetes Mellitus type II. The aim of this study is assessment of the effect of toe rocker on gait kinematics and temporal- special parameters. To perform this study, the inclusion and exclusion criteria will be matched to the volunteers and after that one subject will be selected to participate in this study.
This study is designed to be perform in two phases: the base phase and the intervention phase. The base phase will be done at first and when having no orthotic intervention. The base phase has 5 trials that will be done with equal intervals. The base phase will be performed in 5 weeks, every week one session. When the base phase finished, the appropriate orthoses with the toe rocker will be fabricated for the participant. Then the orthosis will be delivered to the participant and after a week the intervention phase will be started. The intervention phase will be done in 5 trials with equal intervals, like the base phase. For the statistical analysis, visual analysis will be used. The appropriate method to detect significant difference between the base phase and the intervention phase, the celeration line method will be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016090429684N1
Registration date:2017-05-04, 1396/02/14
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-05-04, 1396/02/14
Registrant information
Name
Kourosh Barati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 935 882 7110
Email address
barati.k@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences, Student research commitment
Expected recruitment start date
2017-07-01, 1396/04/10
Expected recruitment end date
2017-12-17, 1396/09/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of The Toe Rocker on The Gait Kinematics and Temporal Spacial Parameter in Diabetics Type II Patients, Single Subject Design (SSD)
Public title
The Effect of Toe Rocker on The Gait Kinematics and Temporal Spacial Parameter in Diabetics Type II Patients, Single Subject Design (SSD)
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:
diabetics type 2 that have normal gait pattern and muscle strength
exclusion criteria:
History of musculoskeletal disorders in lower limb
History of lower limb truma
Using lower limb orthosis
History of lower limb operation
Gait abnormalities that are detectable with eyes, for example: lateral bending, backward bending and hyper lorodsis, forward bending in gait initiation, leg length discrepancy, hyper extension/ flexion in knee
Age
From 15 years old to 55 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee of Iran University of Medical Sciences
Street address
Hemmat expansion, Tehran, Iran
City
Tehran
Postal code
Approval date
2016-08-31, 1395/06/10
Ethics committee reference number
IR.IUMS.REC.1395.27721
Health conditions studied
1
Description of health condition studied
Dyabetics type II
ICD-10 code
E11
ICD-10 code description
diabetes (mellitus)(nonobese)(obese): adult-onset maturity-onset nonketotic stable type II non-insulin-dependent diabetes of the young
Primary outcomes
1
Description
The kinematics parameter
Timepoint
5 week in the base phase without using orthosis and 5 weeks in the intervention phase after delivering the intervention
Method of measurement
Motion analysis instrument
2
Description
temporal spacial parameter
Timepoint
5 week in the base phase without using orthosis and 5 weeks in the intervention phase after delivering the intervention
Method of measurement
Motion analysis instrument and force plate
Secondary outcomes
empty
Intervention groups
1
Description
Toe rocker
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
the hospitals that are managed by the Iran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences, the student research committee
Full name of responsible person
Koorosh Barati
Street address
Hemmat expansion, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences, the student research committee
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
IUMS
Full name of responsible person
Koorosh Barati
Position
PhD candidate
Other areas of specialty/work
Street address
Department of Orthosis & prosthesis, School of rehabilitation Sciences, Shahnazari St, Madar Sq, Mirdamad Ave, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 8670 2555
Fax
Email
Barati.koorosh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
IUMS
Full name of responsible person
Koorosh Barati
Position
PhD candidate
Other areas of specialty/work
Street address
School of rehabilitation, Shahnazari St, Mirdamad Ave