Protocol summary

Summary
Functional improvement is an important aim of rehabilitation of stroke patients. Among rehabilitation paradigms developed to improve mobility in stroke subjects, the most popular is treadmill training, alone, or combined with partial body weight support. Such training paradigms, in which subjects are trained at their preferred speed, lead to improvements in gait speed that are modestly superior to those obtained by conventional gait training The aim of this study is to examine functional improvement in chronic stroke patients after walking retraining at faster than preferred walking speeds. The chronic stroke patients in Semnan city (n = 15) will participate in treadmill training with their self-selected preferred speed + 40%, three times per week for 4 weeks. Subjects will be assessed before and after the intervention and at follow-up after 45 days. Inclusions criteria - the participants will be more than six months post-stroke with an ability to walk at least 10 m independently. Functional improvement will be evaluated using Timed Up & Go, 6-Minute Walk test, 10 Meter Walk test, and lower extremity Fugl-Meyer Assessment Scale

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042427562N1
Registration date: 2016-05-30, 1395/03/10
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-30, 1395/03/10
Registrant information
Name
Roghayeh Mohammadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
mohammadipt@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Govermental
Expected recruitment start date
2016-05-30, 1395/03/10
Expected recruitment end date
2016-08-20, 1395/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of increasing treadmill speed on functional improvement in chronic stroke patients
Public title
The effect of fast walking in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all subjects are able to walk at least 10 m Independently; all subjects are more than six months post stroke; the affected area is cerebral cortex; subjects are 45 to 70 years old Exclusion criteria: comprehensive aphasia; major cognitive impairment; incontinence; history of falling; sensory disturbance of the lower limbs; cerebellum impairment; and any condition (apart from stroke) that affect their walking ability
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 15
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
Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Iran
Approval date
2016-03-17, 1394/12/27
Ethics committee reference number
IR.SEMUMS.REC.1394.195

Health conditions studied

1

Description of health condition studied
post-stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction

Primary outcomes

1

Description
Patient function
Timepoint
Befor,after and 45 dayes after intervention
Method of measurement
Timed Up & Go, 6-Minute Walk, 10 Meter Walk tests

Secondary outcomes

1

Description
Lower extermity function
Timepoint
Before, after, and 45 days after intervention
Method of measurement
Fugl-Meyer lower extremity assessment

Intervention groups

1

Description
The chronic stroke patients will train in treadmill with their self-selected preferred speed + 40%, for 30 min, three times per week for 4 weeks.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
Neuromuscular Rehabilitation Research Center, Qods St, Mashahir Sq, Semnan, Iran
City
semnan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
PhD, Assistant professor
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
mohammadipt@semums.ac.ir,mohamadipt@gmail.com,mohamadi_pt@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
PhD in Physical Therapy
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
mohammadipt@semums.ac.ir, mohamadipt@gmail.com,mohamadi_pt@yahoo.com
Web page address
www.semums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
PhD in Physical Therapy
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Postal code
Phone
+98 23 3365 4180
Fax
Email
mohammadipt@semums.ac.ir, mohamadipt@gmail.com, mohamadi_pt@yahoo.com
Web page address
www.semums.ac.ir

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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