To determine the effectiveness of routine physical therapy with and without motor relearning program on balance and upright mobility in subacute stroke patients.
Design
Single blinded Randomized controlled clinical trial
Settings and conduct
Shaikh Zayed Hospital, Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria: sub-acute stroke patients diagnosed by neuro physician; Age between 20-50 years; Both male and female; The first time stroke; being able to follow simple instructions; being able to rise from a chair without or with assistive devices. Non-inclusion criteria: having other neurological disorders; suffering from moderate to severe spasticity; having a musculoskeletal disorder of lower limbs; Presence of an unstable medical condition such as severe hypertension, convulsion and complete sensory loss of an upper limb.
Intervention groups
Intervention group: receiving routine physical therapy along with motor relearning training in sit to stand component. Sit to stand training consists of 100 repetition (10 sets of 10 repetition each), 5 days a week for four weeks.
Control group: will receive the routine physical therapy treatment that will include stretching exercises, strengthening the lower and upper extremities balance training, and gait training 5 days a week for 4 weeks.
Main outcome variables
Berg Balance Scale; Time Up & Go Test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200218046539N1
Registration date:2020-03-15, 1398/12/25
Registration timing:registered_while_recruiting
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
Afsheen Jawwad
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 35957538
Email address
afsheen.jawwad@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-13, 1398/08/22
Expected recruitment end date
2020-08-13, 1399/05/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of routine physical therapy with and without motor relearning program on balance and upright mobility in sub-acute stroke patients.
Public title
Effectiveness of motor relearning program on balance and upright mobility in sub-acute stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed sub-acute stroke patients by neuro physician
Age between 20-50 years
Both male and female patients
Patients must have been diagnosed as having suffered a first stroke
Patients had to be able to follow simple instructions
Participant should be able to rise from chair without or with using assistive devices such as cane, walker or crutches
Exclusion criteria:
Patient having other neurological disorders
Patients suffering from moderate to severe spasticity
Patients having musculoskeletal disorders of lower limbs
Patient of an unstable medical condition such as severe hypertension, convulsion and complete sensory loss of an upper limb
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Patients fulfilling the inclusion criteria will be randomly divided into two groups by using the lottery method.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study will be single-blinded. The patients will be unaware of the treatment given to each group. Patients will not know about the treatment and group allocation and it will be achieved by random numbers.
Placebo
Not used
Assignment
Other
Other design features
No
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board
Street address
Main Campus, University of Lahore, Lahore
City
Lahore
Postal code
54000
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IRB/SZMC/EXTRERNAL/179/19
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
164
ICD-10 code description
Stroke, not specified as hemorrhage or infarction
Primary outcomes
1
Description
Berg Balance Scale
Timepoint
Before intervention and at 4 weeks of intervention and at 8 weeks of intervention.
Method of measurement
Scoring
Secondary outcomes
1
Description
Time Up and Go Test score
Timepoint
Before and after 4 weeks of intervention and at 8th week of intervention
Method of measurement
Time Up and Go Test
Intervention groups
1
Description
Intervention group: will receive routine physical therapy along with motor relearning training in sit to stand component by placing paralytic foot behind the unaffected foot, while moving knees forward on chair and keeping trunk in flexion. Sit to stand training consists of 100 repetition (10 sets of 10 repetition each) for 5 days a week for duration of four weeks . Data will be collected on selected questionnaire to access patient’s improvements.
Category
Treatment - Other
2
Description
Control group: will receive the routine physical therapy treatment that will include stretching exercises, strengthening the lower and upper extremities balance training, and gait training 5 days a week for 4 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology Department, Shaikh Zayed Hospital and Federal Postgraduate Medical Institute, Lahore
Full name of responsible person
Dr. Afsheen Naz
Street address
Shaikh Zayed Medical Complex, University Avenue, Block D Muslim Town, Lahore, Punjab
City
Lahore
Postal code
54000
Phone
+92 42 35865731
Email
afsheen.jawwad@yahoo.com
Web page address
https://www.szmc.org.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Lahore
Full name of responsible person
Dr. Afsheen Naz
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Postal code
54000
Phone
+92 42 99200600
Email
afsheen.jawwad@yahoo.com
Web page address
https://www.uol.edu.pk
Grant name
N/A
Grant code / Reference number
N/A
Is the source of funding the same sponsor organization/entity?