Protocol summary

Summary
The aim of this research was to study the effect of heel-to-toe rocker shoe on pain, disability, activity limitation, and vertical ground reaction force in patients with rheumatoid arthritis. In this clinical trial, 21 patients aged 20-65 with foot /ankle joint pain referred to Firozgar hospital and rheumatology clinics were recruited. VGRF with force plate and pain, disability, activity limitation with FFI questionnaire were assessed at the baseline, 1 week and 1 month after treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138812123101N2
Registration date: 2010-05-08, 1389/02/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-08, 1389/02/18
Registrant information
Name
Mohamad Sadegh Ghasemi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 9086
Email address
m.s.ghasemi@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2008-12-05, 1387/09/15
Expected recruitment end date
2010-02-02, 1388/11/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of High-top shoes with Rocker sole on Pain, Disability, Activity Limitation and Vertical Ground Reaction Force in Rheumatoid Arthritis Patients
Public title
Effect of High-top shoes with Rocker sole on Pain, Disability, Activity Limitation and Vertical Ground Reaction Force in Rheumatoid Arthritis Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: RA diagnosis according to the 1987 revised American College of Rheumatology (ACR) recommendations, Low DAS28, disease longer than one year, ability to walk without assistive devices, no use of other foot orthoses during the study, foot and/or ankle pain, Exclusion criteria: Previously undergone major joint surgery such as total joint arthroplasties and/or arthrodesesm, pregnancy, previously cortisone injection at 3 month prior to the study, presence of balance problems, skin lesions (ulcers, dermatitis), other systemic disease with relevant effects on walking ability, other joint deformities
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 21
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 Committee of Faculty of Rehabilitation, Iran University of Medical Sciences
Street address
Rehabilitation collage, Shahnazari St, Madar Ave, Mirdamad,
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
159

Health conditions studied

1

Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M06.9
ICD-10 code description
Rheumatoid arthritis, unspecified

Primary outcomes

1

Description
Activity limitation
Timepoint
Baseline, 1 week and 1 month after rocker shoe Prescription
Method of measurement
Foot Function Index questioner

2

Description
Vertical ground reaction force
Timepoint
before, 1 week, 1 month after rocker shoe Prescription
Method of measurement
force plate

3

Description
Pain
Timepoint
Baseline, 1 week and 1 month after rocker shoe prescription
Method of measurement
Foot Function Index questionnaire

4

Description
Disability
Timepoint
Baseline, 1 week and 1 month after rocker shoe prescription
Method of measurement
Foot Function Index questioner

Secondary outcomes

empty

Intervention groups

1

Description
high top shoe with heel-to-toe rocker sole
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firozgar hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Iran University of Medical Sciences
Full name of responsible person
Dr M. Moradi Lakeh
Street address
Iran University of Medical Sciences, Hemmat Expway
City
Tehran
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, Iran 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
Faculty of Rehabilitation, Iran University of Medical Sciences
Full name of responsible person
Dr Mohamad Sadegh Ghasemi
Position
Assistant Professor, PhD
Other areas of specialty/work
Street address
Rehabilitation collage, Shahnazari St, Madar Ave, Mirdamad,
City
Tehran
Postal code
Phone
+98 21 2222 9086
Fax
Email
m.s.ghasemi@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Rehabilitation, Iran University of Medical University
Full name of responsible person
Masumeh Bagherzadeh cham
Position
Master of science in orthotics and prosthetics
Other areas of specialty/work
Street address
Rehabilitation collage, Shahnazari St, Madar Ave, Mirdamad,
City
Tehran
Postal code
Phone
+98 21 2222 7159
Fax
Email
masumehbagherzadeh@gmail.com
Web page address

Person responsible for updating data

Contact

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
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