To determine the effects of spinal segmental exercises versus conventional treatment to improve trunk stability in sub acute stroke.
Design
RCT
Settings and conduct
Trial conduct in private clinics, Laraib physiotherapy clinic and perfect physio care clinic D.G.Khan.
It was a single blind study in which participants are blind
Participants/Inclusion and exclusion criteria
INCLUSION CRITERIA:
a) Patients within 1 year after onset of stroke.
b) Age 35 to 60 years.
c) Patients with positive sharpened Romberg test (static balance).
d) Patients with Modified Functional reach test (Dynamic balance) specific for sub acute.
EXCLUSION CRITERIA
a) Patients of pusher syndrome (defined as inclination to the hemi paretic side and giving resistance to any attempt at passive correction).
b) Any incurable illness.
c) Pain, limitation in the non-paretic lower extremity or restricted motion.
d) Patient with cognitive disorders.
Intervention groups
INTERVENTIONAL PROTOCOL
Group A: In conventional group total 11 patients was recruited by giving conventional therapy for the period of 12 week, consisting of 1 hour of treatment per day, 3 times a week for 12 weeks. Conventional exercises include Exercise 1: supine lying – Leg lifts. Exercise 2: Abdominal crunches in crook lying position. Exercise 3.Back Isometrics.
Main outcome variables
Two outcome measuring tools was used TIS (Trunk impairment scale) and Posture Zone mobile app.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201220049773N1
Registration date:2021-03-03, 1399/12/13
Registration timing:retrospective
Last update:2021-03-03, 1399/12/13
Update count:0
Registration date
2021-03-03, 1399/12/13
Registrant information
Name
Unaza Laraib
Name of organization / entity
Country
Pakistan
Phone
+92 64 2403588
Email address
unaiza_laraib94@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-01, 1398/11/12
Expected recruitment end date
2021-02-15, 1399/11/27
Actual recruitment start date
2020-02-29, 1398/12/10
Actual recruitment end date
2021-02-15, 1399/11/27
Trial completion date
2021-03-15, 1399/12/25
Scientific title
EFFECTS OF SPINAL SEGMENTAL EXERCISES VERSUS CONVENTIONAL TREATMENT TO IMPROVE TRUNK STABILITY IN SUB ACUTE STROKE
Public title
EFFECTS OF SPINAL SEGMENTAL EXERCISES VERSUS CONVENTIONAL TREATMENT TO IMPROVE TRUNK STABILITY IN SUB ACUTE STROKE
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
a) Patients within 1 year after onset of stroke.
b) Age 35 to 60 years.
c) Patients with positive sharpened Romberg test (static balance).
d) Patients with Modified Functional reach test (Dynamic balance) specific for sub acute.
Exclusion criteria:
a) History other neurologic diseases or earlier stroke.
b) Any incurable illness.
c) Pain, limitation in the non-paretic lower extremity or restricted motion.
d) Patient with cognitive disorders.
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Actual sample size reached:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants are blind, they don't know in which group they were allocated.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Secretary Ethical review committee Riphah college of rehabilitation and Allied health sciences
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Postal code
32200
Approval date
2020-03-27, 1399/01/08
Ethics committee reference number
022725
Health conditions studied
1
Description of health condition studied
Sub acute stroke
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
To improve trunk stability in sub acute stroke patients
Timepoint
12 weeks after intervention
Method of measurement
Trunk impairment scale and posture zone mobile app
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
Intervention group: In clinical group total 11 patients was recruited by giving training program of spinal segmental exercises for 3 sessions, 1 hour per day, during a period of 12 weeks. Without devices the bed exercises consisted of bridge exercise with legs crossed, bridge exercise, bridge exercise with one leg, side bridge exercises, curl up with straight reaching and curl up with diagonal reaching
Category
Rehabilitation
2
Description
Control group: In conventional group total 11 patients was recruited by giving conventional therapy for the period of 12 week, consisting of 1 hour of treatment per day, 3 times a week for 12 weeks. Conventional exercises include Exercise 1: supine lying – Leg lifts. Exercise 2: Abdominal crunches in crook lying position. Exercise 3.Back Isometrics.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Laraib physiotherapy clinic
Full name of responsible person
Unaiza Laraib
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Postal code
32200
Phone
+92 64 2403588
Fax
Email
unaiza_laraib94@hotmail.com
Web page address
2
Recruitment center
Name of recruitment center
Perfect physio care clinic
Full name of responsible person
Dr Rizwan Ahmed Qureshi
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Postal code
32200
Phone
+92 64 2403588
Email
unaiza_laraib94@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University Islamabad
Full name of responsible person
Dr Misbah Waris
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Postal code
32200
Phone
+92 64 2403588
Email
Misbah.Waris@riphah.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Misbah Waris
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University Islamabad
Full name of responsible person
Dr Misbah Waris
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Neurology
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Province
Punjab
Postal code
32200
Phone
+92 64 2403588
Email
Misbah.Waris@riphah.edu.pk
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University Islamabad
Full name of responsible person
Dr Misbah Waris
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Neurology
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Province
Punjab
Postal code
32200
Phone
+92 64 2403588
Email
Misbah.Waris@riphah.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University Islamabad
Full name of responsible person
Dr Misbah Waris
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Neurology
Street address
House no 950, Block 18 fareed abad colony
City
D.G.Khan
Province
Punjab
Postal code
32200
Phone
+92 64 2403588
Email
Misbah.Waris@riphah.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Effects of spinal segmental exercises versus conventional treatment to improve trunk stability in sub acute stroke
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Not yet decided
Under which criteria data/document could be used
Not yet decided
From where data/document is obtainable
Not yet decided
What processes are involved for a request to access data/document