Objectives:The aim of this study is to evaluate the effect of Rocker shoes on rocker function in hemiplegic patients walking with Ankle Foot Orthosis (AFO. Design: twenty post-stroke hemiplegic patients aged between 45-70 (men and women) will participate in present study. They will be randomly selected from patients referred to rehabilitation centers of Hamadan .Setting and conduct: Patients will be present at the test center two times. At the first time their lower extremity will be examined too prepare rocker shoes, standard shoes and AFO for them. At the second session, the shoes and AFO will be delivered to the patients, and then, the immediate effect of each type of shoes on plantar forces and pressures and self selected speed will be evaluated by pedar system while participants walking with AFO. Participants: The inclusion criteria for the participants of the presents study is being at least six months post-stroke; having the ability of walking for 10 meters independently and having maximum spasticity of 2 according to Modified Ashworth Scale. Intervention: Interventions includes Rocker shoes, Standard shoes and AFO. Main outcome measures: Heel Mean Force, Toe Mean Force, Heel Impulse, Toe Impulse, Single Support time, Preferred Walking Speed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015103124802N1
Registration date:2016-01-27, 1394/11/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-27, 1394/11/07
Registrant information
Name
Farzad Farmani
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1037
Email address
f.farmani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamadan University of Medical Sciences
Expected recruitment start date
2015-12-01, 1394/09/10
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rocker bar shoes on rocker function in hemiplegic patients walking with Ankle Foot Orthosis
Public title
The effect of rocker shoes on walking with ankle foot orthosis in patients with hemiplegia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria
Having the spasticity score of 3 or more according to Modified Ashworth Score; Having the ability of walking at least 10 meters independently; Being at least 6-month post stroke.
Exclusion critera:
Having cardiovascular problem; Having any history of surgery in their spine and lower limbs; Lack of the ability to perform the tests.
Age
From 45 years old to 70 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized block design was used for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh Blvrd.
City
Hamadan
Postal code
6517838736
Approval date
2015-10-17, 1394/07/25
Ethics committee reference number
IR.UMSHA.REC.1394.313
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Heel mean force
Timepoint
Immediate effect
Method of measurement
By Pedar system
2
Description
Heel impulse
Timepoint
Immediate effect
Method of measurement
By Pedar system
3
Description
Toes mean force
Timepoint
Immediate effect
Method of measurement
By Pedar system
4
Description
Toes impulse
Timepoint
Immediate effect
Method of measurement
By Pedar system
5
Description
Single supprot time
Timepoint
Immediate effect
Method of measurement
By Pedar system
6
Description
Preferred walking speed
Timepoint
Immediate effect
Method of measurement
10-meter walk test
Secondary outcomes
empty
Intervention groups
1
Description
Standard shoes : Includes a pair of high top shoes whose soles are almost flat with the height of 2-cm. They will be used along with Ankle Foot Orthosis.
Category
Treatment - Devices
2
Description
Rocker shoes which includes a pair of high top shoes that their outsole from heel to just proximal to the metatarsal heads are flat. Rocker modification is started from metatarsal heads to the tip toes portion. The hight of sole is 2-cm and will be used along with Ankle Foot Orthosis.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Farzad Farmani
Street address
Shahid fahmideh blvrd.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Ali Abdoli
Street address
Shahid fahmideh blvrd.
City
Hamadan
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, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Farzad Farmani
Position
Assistant professor/Ph.D
Other areas of specialty/work
Street address
Shahid fahmideh Blvrd.
City
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Fax
+98 81 3838 1572
Email
Farmani.farzad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzad Farmani
Position
Assistant professor/Ph.D
Other areas of specialty/work
Street address
Shahid fahmideh blvrd
City
Hamadan
Postal code
6517838736
Phone
+98 81 3838 1571
Fax
+98 81 3838 1572
Email
farmani.farzad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Farzad Farmani
Position
Assistant professor/Ph.D
Other areas of specialty/work
Street address
Shahid fahmideh Blvrd.
City
Hamdan
Postal code
6517838736
Phone
+98 81 3838 1571
Fax
+98 81 3838 1572
Email
farmani.farzad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)