Comparison of the effect of reactive and proactive exercises on mean spasticity and functional outcomes among experimental and control groups.
Design
This study is a double blind clinical trial that is performed in parallel on three groups of 10 people: reactive, proactive and control exercises. Randomization of patients participating in this study is done based on a block chart by an uninformed person
Settings and conduct
The place of this study is the physiotherapy ward of Kashani Hospital in Isfahan. After obtaining an ethics license from the Medical Ethics Committee of Isfahan University of Medical Sciences and also registering the study protocol in the Iranian Clinical Trials Registration System, patients with stroke are referred by a neurologist or by advertising in private and public treatment centers under the supervision of the University. Isfahan Medical Sciences are invited to this study.
Participants/Inclusion and exclusion criteria
In this study, patients with stroke are diagnosed by a neurologist. One of the most important conditions for inclusion in the study of these patients is having spasticity in the ankle and mental conditions suitable for performing exercises. Patients should also be able to stand and walk without assistive devices. The most important conditions for exclusion are other neurological problems and pain in the lower extremity.
Intervention groups
In this study, patients are divided into three groups (two groups of reactive and proactive exercise intervention) and the control group. All patients receive conventional evidence-based treatment for stroke rehabilitation. The control group receives only conventional treatment and the two intervention groups receive special balance exercises (reactive and proactive) in addition to conventional treatment according to the type of group.
Main outcome variables
Muscle tone, H reflex latency, H max / M max ratio
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200101045970N4
Registration date:2020-11-10, 1399/08/20
Registration timing:registered_while_recruiting
Last update:2020-11-10, 1399/08/20
Update count:0
Registration date
2020-11-10, 1399/08/20
Registrant information
Name
Ehsan Ghasemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 3089
Email address
eghasemi@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-10, 1399/07/19
Expected recruitment end date
2021-06-09, 1400/03/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of reactive and proactive exercises on ankle spasticity in patients with stroke: a randomized clinical trial
Public title
The effect of exercise therapy on ankle spasticity in patients with stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A history of the first unilateral stroke confirmed by a neurologist through CT scan or MRI findings.
At least 6 months have passed since the onset of stroke symptoms.
Having spasticity in the gastrocnemius muscle based on the Modified Modified Ashworth Scale (MMAS≥1)
Existence of appropriate cognitive status to understand simple verbal commands and following them based on the Persian version Mini-mental status examination ≥ 24
Ability to stand and walk independently without an aid
Exclusion criteria:
Existence of other neurological disorders such as Parkinson's and ....
Existence of severe visual, profound and vestibular disorders
Existence of severe orthopedic disorders such as fixed contractures in the lower extremities
Severe pain in the lower extremities: According to the VAS scale, pain between 75 and 100 mm
Participate in other rehabilitation treatment interventions
Taking medications that affect the degree of spasticity.
Having a weight of more than 150 kg and a height of more than2.1 meters
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, block randomization method was used for random allocation. Using a statistical software, the statistician designed 10 blocks of 3, considering that we had 3 groups. The person who divides patients according to this table is unaware of the groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in the study are unaware of treatment groups. The outcome assessor is also unaware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
817473461
Approval date
2020-09-06, 1399/06/16
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.302
Health conditions studied
1
Description of health condition studied
stroke
ICD-10 code
G81
ICD-10 code description
Hemiplegia and hemiparesis
Primary outcomes
1
Description
Muscle Tone
Timepoint
Before treatment, after treatment and two months follow-up
Method of measurement
Modified Modified Ashworth Scale
2
Description
H reflex Latency
Timepoint
Before treatment, after treatment and two months follow-up
Method of measurement
Nerve electrical activity recorder
3
Description
H max / M max ratio
Timepoint
Before treatment, after treatment and two months follow-up
Method of measurement
Nerve electrical activity recorder
Secondary outcomes
1
Description
Functional Mobility
Timepoint
Before treatment, after treatment and two months follow-up
Method of measurement
Timed UP and Go test (TUG)
Intervention groups
1
Description
Intervention group: Reactive Exercises:1. Creating disturbance in sitting and standing position 2. Pushing and releasing 3. Standing on an unstable surface 4. Cowboy exercise
Category
Rehabilitation
2
Description
Intervention group: Proactive Exercises: 1. catch and throw the ball 2. spin 3. pull the hand forward 4. stand on one foot 5. stand and walk in a tandem position
Category
Rehabilitation
3
Description
Control group: Conventional physiotherapy, according to studies, includes range of motion exercises related to the upper and lower limbs, weight lifting on the affected side, walking in parallel load forward and backward, pelvic bridging exercises and stretching exercises.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Kashani Hospital
Full name of responsible person
Dr. Majid Ghasemi
Street address
Kashani
City
Isfahan
Province
Isfehan
Postal code
۸۳۴۳۴-۸۱۸۳۹
Phone
+98 31 3233 0091
Fax
+98 31 3233 5030
Email
kashani@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoi Javanmard
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5043
Email
eghasemi@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5043
Email
eghasemi@rehab.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Ehsan Ghasemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Hezar Jrib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 5043
Email
eghasemi@rehab.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to misuse of information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Study protocol, informed consent form and clinical study report
When the data will become available and for how long
The study protocol and consent form are now available in the proposal. The clinical study report will be published after the work is completed.
To whom data/document is available
All researchers working in scientific institutes can access the proposal.
Under which criteria data/document could be used
To be aware of the study conditions and get acquainted with scientific concepts.
From where data/document is obtainable
Contact Dr. Ehsan Ghasemi via email or mobile.
What processes are involved for a request to access data/document
Immediately after sending the email and receiving the request.