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Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients

Primary Purpose

Ischemic Stroke, Acute

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Physiotherapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Ischemic Stroke, Acute

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers
  • Inclusion Criteria:

    • Sub-Acute ischemic and stroke diagnosed by neuro-physican having 1st episode
    • Patients in sub-acute stage (2-12 weeks)
    • Patients who can follow the instruction according to mini mental scale < 7
    • Minimum score of a patient on burg balance and trunk impairment scale to enter in rehab unit and include in any research i-e TIS < 2 in scoring and BBS < 4 minimum scoring.
  • Exclusion Criteria:

    • Recurrent stroke
    • Subjects with radiating pain or nerve root involvement
    • Diagnosed by any neurological condition other than stroke, or other clinical comorbidity that affect the trunk balance.
    • Patient unable to follow the instructions
    • Comprehension deficits that prevented them from following verbal commands
    • Unconscious patient

Sites / Locations

  • Duaa Awais

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

experimental group

control group

Arm Description

core-stability exercises therapy given with conventional therapy

only conventional therapy given

Outcomes

Primary Outcome Measures

Change from baseline in Berg balance scale at week 4
Berg balance scale(BBS) used clinical test of a person's static and dynamic balance abilities. BBS comprises a set of 14 items which includes unsupported sitting to unsupported standing and weight shifting while standing unsupported. Lower score =1 (Sitting to standing) Higher score=14 (weight shifting while standing)
Change from baseline in Trunk impairment scale at week 4
The Trunk Impairment Scale (TIS) is a tool to measure motor impairment of the trunk after stroke. TIS scores on a range from 0 to 23. Static sitting balance, Dynamic sitting balance and Co-ordination will be evaluated by this scale. Static sitting balance=7 Dynamic sitting balance=10 Co-ordination=6

Secondary Outcome Measures

Full Information

First Posted
August 15, 2022
Last Updated
August 18, 2022
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05510258
Brief Title
Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients
Official Title
Comparison of Routine Physical Therapy With and Without Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Sub-acute Ischemic Stroke Patient
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
January 7, 2020 (Actual)
Primary Completion Date
March 2, 2020 (Actual)
Study Completion Date
March 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total two groups included control and experimental and sample size was 48 and 24 persons divided in each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of p valued 0.05. Results were in the favour of experimental group.
Detailed Description
This is ROM trail study. Data collected from Physiotherapy department of Rabbani Hospital Lahore . In this study total two groups included control and experimental and sample size was 48 and 24 persons randomly allocated in each groups as well. In control group conventional therapy given while in experimental group core-stability exercises with conventional therapy given to the patients. while the duration of therapy was 45 minutes per day for 8 weeks. Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to measure the outcomes. Only having first episode of sub-acute stoke patients and diagnosed by Neuro-physician were included in study. Data entered and analysed by SSPS V21.0 with a significant level of p valued 0.05. and the results were in the favour of study means experimental group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Acute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups control and experimental included
Masking
Care Provider
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
core-stability exercises therapy given with conventional therapy
Arm Title
control group
Arm Type
Other
Arm Description
only conventional therapy given
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
TWO GROUPS CONTROL ND EXPERIMENTAL
Primary Outcome Measure Information:
Title
Change from baseline in Berg balance scale at week 4
Description
Berg balance scale(BBS) used clinical test of a person's static and dynamic balance abilities. BBS comprises a set of 14 items which includes unsupported sitting to unsupported standing and weight shifting while standing unsupported. Lower score =1 (Sitting to standing) Higher score=14 (weight shifting while standing)
Time Frame
Baseline and 4 weeks
Title
Change from baseline in Trunk impairment scale at week 4
Description
The Trunk Impairment Scale (TIS) is a tool to measure motor impairment of the trunk after stroke. TIS scores on a range from 0 to 23. Static sitting balance, Dynamic sitting balance and Co-ordination will be evaluated by this scale. Static sitting balance=7 Dynamic sitting balance=10 Co-ordination=6
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub-Acute ischemic and stroke diagnosed by neuro-physican having 1st episode Patients in sub-acute stage (2-12 weeks) Patients who can follow the instruction according to mini mental scale < 7 Minimum score of a patient on burg balance and trunk impairment scale to enter in rehab unit and include in any research i-e TIS < 2 in scoring and BBS < 4 minimum scoring. Exclusion Criteria: Recurrent stroke Subjects with radiating pain or nerve root involvement Diagnosed by any neurological condition other than stroke, or other clinical comorbidity that affect the trunk balance. Patient unable to follow the instructions Comprehension deficits that prevented them from following verbal commands Unconscious patient
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rabbani Hospital
Organizational Affiliation
PMDC
Official's Role
Study Chair
Facility Information:
Facility Name
Duaa Awais
City
Lahore
State/Province
Punjab
ZIP/Postal Code
53700
Country
Pakistan

12. IPD Sharing Statement

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Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients

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