Investigating the effect of using a dual training course with and without AFO on walking rehabilitation in stroke patients.
Design
A randomized control trial with a control group, parallel, is performed on 32 patients.
randomization method: random number table
Settings and conduct
The type of study is a open-label randomized controlled clinical trial. Therapeutic interventions for each group will be carried out in 3 weeks. The sampling location is only one rehabilitation center.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
All participants are stroke patients, at least six months and at most one year have passed since their stroke.
Hearing and vision are healthy
The degree of spasticity of the gastrosoleus muscle should be less than 2 according to the Ashworth scale.
Exclusion criteria:
People with very poor balance
Inability to perform the cognitive task used in the dual walking task
Severe cognitive deficits
Intervention groups
Patients in the study group will receive dual exercises while wearing the orthosis, and patients in the control group will receive dual exercises alone.Dual walking exercises for stroke patients include dual cognitive-motor and movement exercises.
Main outcome variables
Spatio-temporal parameters, and kinetic and kinematic parameters of hip, knee and ankle joints
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220806055629N1
Registration date:2023-07-29, 1402/05/07
Registration timing:registered_while_recruiting
Last update:2023-07-29, 1402/05/07
Update count:0
Registration date
2023-07-29, 1402/05/07
Registrant information
Name
Negin Mizangir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4422 7356
Email address
neginmz09@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-11, 1402/04/20
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of a dual-task exercise course with and without ankle-foot orthosis on walking retraining in stroke patients
Public title
Effects of a dual-task exercise course with and without ankle-foot orthosis on walking retraining in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All participants are stroke patients that at least six months and at most one year have passed since their stroke.
Having normal/healthy Hearing and vision
Absence of neurological disorders and pain while walking
Be able to follow verbal instructions and provide verbal responses to questions
No previous history of using any type of orthosis
The degree of spasticity of the gastrosoleus muscle should be less than 2 according to the Ashworth scale
Having the ability to walk independently for at least 12 meters with or without the use of an aid such as a cane or a walker
Needing to gait training under the supervision of a physiotherapist
Exclusion criteria:
History of balance deficits unrelated to stroke
Individuals with very poor balance
Inability to perform the cognitive task used in the dual walking task
Severe cognitive deficits
Any complex medical history that could interfere with the intervention such as pulmonary problems or Orthopedic disorders
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The block randomization method is used to assign the participants to two groups of sixteen. In the block randomization method, we create blocks of four and randomly select a block of four for each four people. The block modes of four are as follows: AABB, ABAB, ABBA, BAAB, BABA, BBAA. We randomly choose one of the six quadruple block modes. For example, if the first mode is AABB, the first and second players are in group A, and the third and fourth players are in group B. We put them in the envelope and number each one from 1 to 32.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethic Committees of Vice Chancellor in Research Affairs Shahid Beheshti University of Medic
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.200
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I60-I69
ICD-10 code description
Cerebrovascular diseases
Primary outcomes
1
Description
Walking speed
Timepoint
At the beginning of the study and after three weeks of intervention
Method of measurement
3D analysis motion system
Secondary outcomes
1
Description
Kinematic parameters of ankle, knee and hip joints
Timepoint
At the beginning of the study and after three weeks of intervention
Method of measurement
3D analysis motion system
2
Description
Kinetic parameters of ankle, knee and hip joints
Timepoint
At the beginning of the study and after three weeks
Method of measurement
3D analysis motion system and force plate
Intervention groups
1
Description
Intervention group: performing dual-task exercises along with wearing ankle-foot orthosis. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time.
Category
Rehabilitation
2
Description
Control group: only performing dual-task exercises. Patients receive therapeutic interventions for two weeks and 5 sessions per week. Dual-task exercises are performed for 30 minutes and 5 times a week, with 3-4 repetitions each time.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic, Faculty of Rehabilitation, University of Medical Sciences Shahid Beheshti
Full name of responsible person
Negin Mizangir
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
neginmz09@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences., Arabi Ave., Daneshjoo Blvd., Velenjak.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Mizangir
Position
Master student of Shahid Beheshti
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
neginmz09@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Mizangir
Position
Master student of Shahid Beheshti
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
neginmz09@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Negin Mizangir
Position
Master student of Shahid Beheshti
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation., Shahid Beheshti University of Medical Sciences., Damavand St., Emam Hossein Sq
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7754 2057
Email
neginmz09@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
It is not possible to share all the data and only the demographic information of the participants and the results of the study evaluation variables are shared.
When the data will become available and for how long
The data access period starts 6 months after the publication of the article
To whom data/document is available
Working researchers and students in academic centers
Under which criteria data/document could be used
Other researchers as well as therapists in the field of medicine and rehabilitation can use this study after printing the article.
From where data/document is obtainable
Negin Mizangir
What processes are involved for a request to access data/document
After requesting the documents, the person in charge of the research project must receive written permission from the university and send the documents after obtaining the permission. Therefore, the data will be sent approximately 6 months after the request.