To Compare the Effects of Functional Training Program and Conventional Therapy on Postural Control and Functional Mobility in Chronic Stroke
Design
A concealed Randomized blinded trial with parallel groups, 12 patients, enrolled between November 2019 to march 2020 and followed 6 months. Randomization was done using lottery method.
Settings and conduct
Qureshi hospital sahiwal
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Confirmed infarct or hemorrhage by a neurologist using either MRI or CT scan; Patient who was able to follow verbal or demonstrated instruction & direction; Both genders; Patient who was not able to walk independently; Aged 30 – 65 years; Patient after 6 months of stroke. Exclusion criteria: Unstable Cardiovascular conditions, any lower limb musckuloskeletal condition or neurological condition other than stroke that influence posture.
3. Patients with communication barrier and cognitive impairment.
4. Any diagnosed psychological problem.
5. Unable to keep any(Sitting or Standing) position for 30 Second
Intervention groups
Group a: functional training program therapy is applied for postural control and functional mobility for 8 week 3 times per week for 60 min in a day.
Group b :conventional treatment (PROM AAROM AROM) applied for 8 weeks 3 times per week for 60 min in a day.
Main outcome variables
berg balance scale , time up and go test, 6 min walk test , trunk control measurement scale
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200911048687N1
Registration date:2020-12-11, 1399/09/21
Registration timing:retrospective
Last update:2020-12-11, 1399/09/21
Update count:0
Registration date
2020-12-11, 1399/09/21
Registrant information
Name
Qurat-ul-ain .
Name of organization / entity
Ripah international university
Country
Pakistan
Phone
+92 40 4550316
Email address
raoannie316@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-22, 1399/07/01
Expected recruitment end date
2020-11-22, 1399/09/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between Effects of Functional Training Program and Conventional Therapy on Postural Control and Functional Mobility in Chronic Stroke.
Public title
Comparison between Effects of Functional Training Program and Conventional Therapy on Postural Control and Functional Mobility in Chronic Stroke.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmed infarct or Hemorrhagic stroke by a neurologist using either MRI or CT scan
Patient who was able to follow verbal or demonstrated instruction & direction
Both genders
Patient who are not able to walk independently.
Aged 30 – 65 years
Patient after 6 months of stroke
Exclusion criteria:
Unstable CVS status significant lower limb MSK condition or neurological condition other than stroke that influence posture
Patients with communication barrier and cognitive impairment
Any diagnosed psychological problem
Unable to keep any(Sitting or Standing) position for 30 Second
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Each participant was requested to draw a card from a box. Number one was allocated to group A and number two was allocated to group B (lottery method) .Allocation concealment was done through sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study participants were blinded by envelope concealment. participant were not aware to which group they belong.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Ripah College of Rehablitationand allied health sciences
Street address
Madar-e-millat road, Quaideazam industrial estate
City
Lahore
Postal code
54770
Approval date
2020-01-01, 1398/10/11
Ethics committee reference number
RCRS-RE-MS-NMPT/FALL19/026
Health conditions studied
1
Description of health condition studied
chronic stroke
ICD-10 code
ICD-10 code description
chronic stroke
Primary outcomes
1
Description
postural control and functional mobility
Timepoint
total 8 week program and no followup.primary outcome will be measured on 8th week
Method of measurement
berg balance scale, 6 min walk test, time up and go test, trunk control measurement scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: functional training program of 8 week for 3 times per week for 60 minute
Category
Treatment - Other
2
Description
Control group: conventional therapy (AROM, PROM ) for 8 week (3times per week for 60 min)
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Max Rehab lahore
Full name of responsible person
Qurat Ul Ain
Street address
Madar e millat road Quaideazam industrial estate
City
Lahore
Postal code
54770
Phone
+92 42 32172454
Email
raoannie316@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ripah international university
Full name of responsible person
Qurat Ul Ain
Street address
Madar e Millat road, Quaideazam industrial estate
City
Lahore
Postal code
54770
Phone
+92 42 32172454
Email
raoannie316@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ripah international university
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Ripah international university
Full name of responsible person
Qurat ul ain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar e millat road, Quaideazam industrial estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 32172454
Email
raoannie316@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ripah international university
Full name of responsible person
Qurat ul ain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar e millat road, Quaideazam industrial estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 32172454
Email
raoannie316@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ripah international university
Full name of responsible person
Qurat ul ain
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Madar e millat road, Quaideazam industrial estate
City
Lahore
Province
Punjab
Postal code
54770
Phone
+92 42 32172454
Email
raoannie316@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
COMPARISON BETWEEN EFFECTS OF FUNCTIONAL
TRAINING PROGRAM AND CONVENTIONAL THERAPY
ON POSTURAL CONTROL AND FUNCTIONAL MOBILITY
IN CHRONIC STROKE
When the data will become available and for how long
as soon as possible after pubication
To whom data/document is available
it is acailable to all researcher, academics and health sciences.
Under which criteria data/document could be used
it is used for any research purpose, for treatment purpose, for study, and for cite .
From where data/document is obtainable
it is obtainable from all research engine
What processes are involved for a request to access data/document