Effectiveness of routine physical therapy with and without neuromobilization technique on range of motion and functional mobility of upper extremity in sub-acute stroke patients
To evaluate the effectiveness of routine physical therapy with and without neuromobilization technique on range of motion and functional mobility of upper extremity in sub-acute stroke patients.
Design
Randomized clinical trial, parallel groups, no blinding
Settings and conduct
The participants fulfilling criterea were allocated from Omer medical centre, Yaseen medical centre, UOL teaching hospital, Pakistan.
Participants/Inclusion and exclusion criteria
sub-acute stroke patients, aged 40-60 years with spasticity (modified Ashworth Scale with Grade 1, 2 spasticity) were included in this study. While the patients with any other disorder such as cognitive impairment, joint deformity, visual impairment, any other neurological or muscular disorder were excluded.
Intervention groups
Control group received the routine physical therapy treatment that included Tens, hot pack, muscles stretching and range of motion exercises. Each session was given for almost 45-60 minutes thrice a week for 8 weeks. Experimental group received routine physical therapy with neuromobilization of median, radial and ulnar nerve for 8 weeks. Each session was given for almost 45-60 minutes.
Main outcome variables
Range of motion of upper limb
Functional mobility of upper limb
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200225046616N1
Registration date:2020-09-28, 1399/07/07
Registration timing:retrospective
Last update:2020-09-28, 1399/07/07
Update count:0
Registration date
2020-09-28, 1399/07/07
Registrant information
Name
Fariha Khalid
Name of organization / entity
University of Lahore
Country
Pakistan
Phone
+92 42 35220878
Email address
fariha.khalid@dhpt.uol.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-15, 1398/02/25
Expected recruitment end date
2020-05-15, 1399/02/26
Actual recruitment start date
2019-05-21, 1398/02/31
Actual recruitment end date
2020-06-03, 1399/03/14
Trial completion date
2020-08-07, 1399/05/17
Scientific title
Effectiveness of routine physical therapy with and without neuromobilization technique on range of motion and functional mobility of upper extremity in sub-acute stroke patients
Public title
Effects of neuromobilization on upper extremity in stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sub-acute stage (3 weeks to 6 months after onset)
Spastic paralysis (according to the modified Ashworth Scale with Grade 1, 2 spasticity)
age 40-60 years
both male and female
Exclusion criteria:
Cognitive deficiency that would impede the testing procedures
Surgical history of upper limb
Joint deformities of the upper limb
Hemi neglect, visual problem
Any neurological or orthopedic diseases affecting their Upper Limb
Age
From 40 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
26
Randomization (investigator's opinion)
Randomized
Randomization description
30 participant will allocated equally in control or experimental group by simple randomization. A random number table was generated using computer. All random numbers were kept in a sealed envelope. For each patient a sealed envelope was opened and according to mentioned number, group was allocated.
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
Ethic's committee of University of Lahore
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road
City
Lahore
Postal code
54590
Approval date
2019-05-14, 1398/02/24
Ethics committee reference number
IRB-UOL-FAHS/473/2019
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I63.50
ICD-10 code description
Cerebral infarction due to unspecified occlusion or stenosis of unspecified cerebral artery
Primary outcomes
1
Description
Range of Motion
Timepoint
Before intervention, 4th week of intervention, 8th week of intervention
Method of measurement
Goniometry
2
Description
Functional Mobility
Timepoint
Before intervention, 4th week of intervention, 8th week of intervention
Method of measurement
Wolf motor functional scale
Secondary outcomes
empty
Intervention groups
1
Description
Control Group: received the routine physical therapy treatment that included TENS, hot pack, muscles stretching and range of motion exercises. Each session was given for almost 45-50 minutes. In a session, TENS and hot pack was given for 15 minutes. Static stretching of affected muscles was performed according to the participant requirement. The range of motion exercises included arm cradling, table top position, while sitting leans forward and reaches both hands down to the floor and in Supine hands are clasped together and placed behind the head, the elbows fall flat to the mat. For muscles strengthening, exercises with free weight and elastic bands were performed, resistance depending upon patients muscle strength. Fifteen repetitions of each exercise was given with a resting period of 1 minute between exercises
Category
Rehabilitation
2
Description
Intervention group: received routine physical therapy with 2 sessions of neuromobilization of median, radial and ulnar nerve per weeks for 8 weeks. Each session was given for almost 45-50 minutes. In one session, routine physiotherapy mentioned above was given with dynamic neuromobilization (20 rep).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
UOL-teaching hospital
Full name of responsible person
Dr Muhammad hussain Iqbal
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Postal code
54590
Phone
+92 42 99200600
Email
hussainiqbal94@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Omer medical centre
Full name of responsible person
Fariha Khalid
Street address
JOHAR TOWN 42 A/III , College Road, near AL JANNAT MARRIAGE HALL, Lahore, Pakistan
City
Lahore
Postal code
54600
Phone
+92 42 35174737
Email
Farihakhalid93@gmail.com
Web page address
3
Recruitment center
Name of recruitment center
Yaseen Medical Centre
Full name of responsible person
Dr fariha Khalid
Street address
246 Allama Iqbal road dharampura
City
Lahore
Postal code
39571
Phone
+92 42 35220878
Email
Farihakhalid93@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Lahore
Full name of responsible person
Dr Ashfaq Ahmad
Street address
University of Lahore, Main Campus, Lahore
City
Lahore
Postal code
54590
Phone
+92 42 99200600
Email
Farihakhalid93@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Lahore
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
The university of Lahore
Full name of responsible person
Dr Fariha Khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
Farihakhalid93@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Fariha khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
farihakhalid93@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Lahore
Full name of responsible person
Dr Fariha khalid
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
1-Km, Defence Road, Bhupatian Chowk, Off Raiwind Road, Lahore.
City
Lahore
Province
Punjab
Postal code
54590
Phone
+92 42 99200600
Email
farihakhalid93@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Data will be available to other people after the completion of study and remained available till 3 months
To whom data/document is available
Data will be available to people working in academic institutions