To evaluate the effectiveness of segmental muscle vibration (SMV) and bimanual task-oriented training (TOT) on hemiparetic upper extremity functional performance in a patient with subacute ischemic stroke.
Design
A concealed, single-blinded, randomized control trial with parallel group design of 50 patients, enrolled between July to August 2022, and followed for 2 months.
Settings and conduct
Data was collected from Dr. Ajaz Ali Physical Therapy clinic Gujrat and District Head Quarter hospital Jhelum, Punjab Pakistan and conduct between month of August and November. Data analyst was blinded in this research because he was kept unaware of which interventions apply to which group.
Participants/Inclusion and exclusion criteria
inclusion criteris
1. Patients 30-70 year of age.
2. Patients with hemiplegic ischemic stroke.
3. patients in the subacute phase after having a stroke (within 1 to 6 months after stroke)
4. Able to understand and follow instructions.
5.stable medical conditions
The participants were excluded if they had:
1. Other neurological disease (e.g. Parkinson`s disease or Alzheimer`s disease)
2. Musculoskeletal problems (e.g. carpal tunnel syndrome, tendinitis of the forearm and wrist and recent fracture)
3. Myopathy (like muscular dystrophy, myasthenia gravis or myotonia)
4. All type of aphasia.
5. visual problems that could not be corrected
Intervention groups
Group A (Experimental group): Segmental muscle vibration along with bimanual task-oriented training was prescribed to the participants of this group.
Group B (Control group): Conventional exercise program was prescribed to participants of this group.
Main outcome variables
Wolf motor function test
Modified Ashworth Scale
ABILHAND questionnaire
Visual analogue scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221210056761N1
Registration date:2022-12-26, 1401/10/05
Registration timing:retrospective
Last update:2022-12-26, 1401/10/05
Update count:0
Registration date
2022-12-26, 1401/10/05
Registrant information
Name
Afifa Tariq
Name of organization / entity
The University of Lahore
Country
Pakistan
Phone
+92 346 5762379
Email address
afifatariq186@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-15, 1401/03/25
Expected recruitment end date
2022-09-15, 1401/06/24
Actual recruitment start date
2022-07-01, 1401/04/10
Actual recruitment end date
2022-09-25, 1401/07/03
Trial completion date
2022-12-09, 1401/09/18
Scientific title
Effectiveness of segmental muscle vibration and bimanual task-oriented training on upper extremities functional ability in poststroke patients
Public title
effectiveness of segmental muscle vibration and bimanual task-oriented training in post-stroke patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients 30-70 year of age.
Patients with hemiplegic ischemic stroke.
Patients is in the subacute phase after having a stroke (within 1 to 6 months after stroke)
Able to understand and follow instructions
Stable medical conditions
Exclusion criteria:
Other neurological disease (e.g. Parkinson`s disease or Alzheimer`s disease)•
Musculoskeletal problems (e.g. carpal tunnel syndrome, tendinitis of the forearm and wrist and recent fracture)
Myopathy (like muscular dystrophy, myasthenia gravis or myotonia)
All type of aphasia.
visual problems that could not be corrected
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
56
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling is used. Randomization by lottery method. Allocation concealment through sealed envelope. In a bowl, we put closed slips of group A and group B. Participants fulfilling inclusion criteria will randomly pick up groups and then allocated them through sealed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the data analyst is kept unaware of the treatment assigned to the experimental group and control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethical committee of University of Lahore, Gujrat campus.
Street address
The University of Lahore, G.T. Road, adjacent Chenab Bridge, Gujrat,
City
Gujrat
Postal code
50700
Approval date
2022-08-21, 1401/05/30
Ethics committee reference number
REG/GRT/22/AHS-87
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63
ICD-10 code description
Cerebral infarction
Primary outcomes
1
Description
spasticity
Timepoint
baseline, after 3 weeks and after 6 weeks of intervention
Method of measurement
modified ashworth scale
Secondary outcomes
1
Description
functional ability
Timepoint
baseline, after 3 weeks and after 6 weeks
Method of measurement
Wolf motor functional test and ABILHAND questionnaire
Intervention groups
1
Description
Intervention group A: Segmental muscle vibration along with bimanual task-oriented training was prescribed to the participants of this group. Each participant practiced four of the six functional tasks they chose, depending on their preference. All participants performed a 10-minute warmup. Then they practice the selected functional task for 30 minutes. During that 30-minute TOT, there was a 3-minute break after continuous practice every 10 minutes. Group A received the segmental muscle vibrator (SMV) at the end of each TOT session for 5 min.
Category
Rehabilitation
2
Description
Control group: Group B received conventional exercise program along with EMS. The conventional exercise program (CEP) included a practice of active movements, active-assisted movements, and passive movements, stretching, strengthening, and coordination exercises to improve the range of motion, muscle strength, and coordination of the affected upper limb.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Ajaz Ali physiotherapy services
Full name of responsible person
dr. Ajaz Ali
Street address
Illahi Plaza opposite Gujrat Gymkhana, Bhimber Road,. Gujrat
City
Gujrat
Postal code
50700
Phone
+92 53 3515229
Email
ejazalisheikh@gmail.com
2
Recruitment center
Name of recruitment center
District Head Quarter Hospital Jhelum
Full name of responsible person
Dr. Amir Minhas
Street address
DHQ Hospital, Old G.T Rd, Mujahidabad, Jada, Jhelum, Punjab.
City
Jhelum
Postal code
49600
Phone
+92 300 9519439
Email
youraamer@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
self
Full name of responsible person
Afifa Tariq
Street address
Street no 1, House no 116, village baherwal, Teh kharian
City
Kharian
Postal code
50090
Phone
+92 346 5762379
Email
afifatariq186@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
self
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
The University Of Lahore
Full name of responsible person
Afifa Tariq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Street no 1, House no 116, Village baherwal, Teh Kharian
City
kharain
Province
Punjab
Postal code
50090
Phone
+92 346 5762379
Email
afifatariq186@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Afifa Tariq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Street no 1, House no 116, Village Baherwal, Teh Kharian
City
Kharian
Province
Punjab
Postal code
50090
Phone
+92 346 4762379
Email
afifatariq186@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
The University of Lahore
Full name of responsible person
Afifa Tariq
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
street no 1, house no116, Village Baherwal, Teh Kharian
City
Kharian
Province
Punjab
Postal code
50090
Phone
+92 346 5762379
Email
afifatariq186@gmail.com
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
there is no further information
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
data collected from the primary outcomes only
When the data will become available and for how long
starting 6 months after publication. when it will be published
To whom data/document is available
people working in academic and clinical practice
Under which criteria data/document could be used
for clinical trial data can be shared
From where data/document is obtainable
through email
afifatariq186@gmail.com
What processes are involved for a request to access data/document
when anyone want to review it and request through email then data will be provided