The purpose of this study is to investigate the effect of eccentric training on knee muscles torque and functional tests in chronic stroke patients.
Design
This study is a randomized clinical trial, with parallel groups, double-blinded with 26 sample size.
Settings and conduct
This study will be performed in the Neuromuscular Rehabilitation Research Center in Semnan. Participants in the experimental group will walk on the treadmill with a negative 10% inclination for 30 minutes. Routine physiotherapy only will be performed in the control group. Training will be performed three times in the weeks for four weeks in both groups. Participants and outcome assessor will be blind in this study. Subjects will not be aware of being in which group. The outcome assessor will be the person other than the main investigator to reduce the bias in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Stroke patients should be in the chronic stage and the spasticity score of plantarflexor muscles should be smaller than 2 in the modified Ashworth scale. Exclusion criteria: Medical condition (apart from the stroke) that impair patients balance
Intervention groups
Participants in the experimental group will walk on the treadmill with a negative 10% inclination. Participants in addition to walking on their treadmill, undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle, balance exercises with tilt board, stretch training of the Gastrocnemius muscle, and training in daily activities). Participants only undergo routine physiotherapy in the control group. Training will be performed three times in the weeks for four weeks in both groups.
Main outcome variables
Quadriceps and Hamstrings muscles torque on the affected side
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027562N7
Registration date:2019-01-06, 1397/10/16
Registration timing:registered_while_recruiting
Last update:2019-01-06, 1397/10/16
Update count:0
Registration date
2019-01-06, 1397/10/16
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
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of eccentric training on knee muscles torque and functional tests in chronic stroke patients
Public title
Effect of training in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients should be more than 6 months poststroke
The spasticity score of plantarflexor muscles should be smaller than 2 in the modified Ashworth scale
Stroke patients should be in the chronic stage
They should be able to walk on treadmill
Exclusion criteria:
Medical condition (apart from stroke) that impair patients balance
Aphasia
Cognition deficiency
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be simple and individually. It will be performed by selecting a closed envelope by every patient, enrolling him/her to the experimental or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participants and outcome assessor will be blind. Despite explained to patients adequately about the intervention, they will not be aware of being in the intervention or control group. The outcome assessor will be the person other than the main investigator to reduce the bias in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SEMUMS.REC.1397.203
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified
Primary outcomes
1
Description
Quadriceps muscle torque on the affected side
Timepoint
Before intervention, and 4 weeks after intervention
Method of measurement
Isokinetic System
2
Description
Hamsrings muscle torque on the affected side
Timepoint
Before intervention, and 4 weeks after intervention
Method of measurement
Isokinetic System
Secondary outcomes
1
Description
Time of the Timed Up and Go test
Timepoint
Before intervention, and 4 weeks after intervention
Method of measurement
Chronometer
2
Description
Berg Balance Scale
Timepoint
Before intervention, and 4 weeks after intervention
Method of measurement
Questionnaire
3
Description
Functional Reach Test
Timepoint
Before intervention, and 4 weeks after intervention
Method of measurement
Ruler
Intervention groups
1
Description
Intervention group: Participants in the experimental group will walk on the treadmill with a negative 10% inclination for 30 minutes. In the first week, they will walk on the treadmill as fast as 55% of maximum heart rate and also they will walk in the second week with 65% of maximum heart rate and in the third week with 75% and in the fourth week with 85% maximum heart rate. Participants in addition to walking on their treadmill, undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for four weeks.
Category
Rehabilitation
2
Description
Control group: Participants undergo routine physiotherapy (functional electrical stimulation of Quadriceps muscle for 10 minutes, balance exercises with tilt board, stretch training of the Gastrocnemius muscle for 15 seconds, and training in daily activities). Training will be performed three times in the weeks for four 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, Ghods Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mohamadipt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23333654180
Email
mohamadipt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available