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Comparison of Core Stability and Otago Exercise on Balance and Quality of Life in Patients With Stroke

Primary Purpose

Stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
core stability exercises
otago exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring balance, quality of life, stroke

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sub acute stroke(3 to 6 months).
  • Ashworth scale 1 to 3.
  • Patients having cognition level is (26-30) according to MOCA.
  • Patients having (21 to 42) score according to BBS.

Exclusion Criteria:

  • Fractures.
  • Participants with recurrent stroke.
  • Participants with sever spasticity
  • Orthopedic or other neurological impairment that could influence balance.

Sites / Locations

  • Bacha khan medical complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

core stability exercises

otago exercises

Arm Description

improve balance and muscle strengthening

improve balance and quality of life

Outcomes

Primary Outcome Measures

Berg balance scale
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.

Secondary Outcome Measures

Functional independence measure
Functional independence measure scale is used to measures of independence for self-care. Functional independence measure scale assess six area of function including sphincter control, transfers, locomotion, communication, and social cognition
Stroke specific quality of life questionnaire
Specific Quality Of Life scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.

Full Information

First Posted
September 21, 2022
Last Updated
October 21, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05591378
Brief Title
Comparison of Core Stability and Otago Exercise on Balance and Quality of Life in Patients With Stroke
Official Title
Comparison of Core Stability and Otago Exercise on Balance and Quality of Life in Patients With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 20, 2022 (Anticipated)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
Core stability and otago exercise program has been proved to be effective in many conditions like muscles strenghing, gait improvement and relieving of pain. Hence the aim of present study is to compare the effectivness of Core stability and Otago exercise on balance and quality of life in patients with stroke.
Detailed Description
The Otago Exercise Program (OEP), consist of resistance training and balance training exercises. The OEP is composed of three domains, namely muscle strengthening, balance training with a progression by increasing ankle cuff weights and number of sets, in association with a walking plan. It is a program that incorporates moderate intensity strength exercises focusing on the lower limbs and balance to be performed for about 30 min at least three times a weekStrength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs.exercises and physical activities could promote balance, flexibility, muscular strength, and walking ability among elderly people.OEP three times a week, for 6 months, can improve dynamic balance.core stability exercises for five weeks in addition to conventional physiotherapy five days a week for the same period, improved dynamic sitting balance, standing balance, gait and activities of daily living at the post intervention assessment in subacute post-stroke survivors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
balance, quality of life, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
core stability exercises
Arm Type
Experimental
Arm Description
improve balance and muscle strengthening
Arm Title
otago exercises
Arm Type
Experimental
Arm Description
improve balance and quality of life
Intervention Type
Other
Intervention Name(s)
core stability exercises
Intervention Description
exercises for 8 weeks and 3 individual sessions per week for 30-45 minutes. Each exercise will be given for 3 to 5 minuts. first week:Cat camel stretch, all fours stretch and lifting one leg, cobra pose, lying on your back and raising the legs/one leg, and hamstring stretch on chair second week:Straight Leg Crunch, with first week exercises third week:Crunch, bridge exercise,and lifting the legs/one leg straight out with first week exercises fourth week:lifting the legs/one leg to the opposite hand, with first week exercises fifth week:Reverse Crunch, bridge exercise without support with first week exercises sixth week:Hamstring stretch on the Floor with first week exercises seventh week:lifting one hand and one leg, with first week exercises eight week:Exercise Ball Crunch,and stability ball bridge with first week exercise
Intervention Type
Other
Intervention Name(s)
otago exercises
Intervention Description
exercises for 8 weeks and 3 individual sessions per week for 30-45 minutes. Each exercise will be given for 3 to 5 minuts. Walking forward with support, standing on heel with support, side walking with support, standing on one foot with support.Walking forward without support, standing on heel without support, side walking without support, standing on one foot without support. Walking backward with support, walking on heel with support, walking and turning around, walking on heel with support. Walking backward without support, walking on heel without support, walking and turning around, walking on heel without
Primary Outcome Measure Information:
Title
Berg balance scale
Description
The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time Frame
8 week
Secondary Outcome Measure Information:
Title
Functional independence measure
Description
Functional independence measure scale is used to measures of independence for self-care. Functional independence measure scale assess six area of function including sphincter control, transfers, locomotion, communication, and social cognition
Time Frame
8 week
Title
Stroke specific quality of life questionnaire
Description
Specific Quality Of Life scale is a patient-centered outcome measure intended to provide an assessment of health-related quality of life specific to patients with stroke.
Time Frame
8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sub acute stroke(3 to 6 months). Ashworth scale 1 to 3. Patients having cognition level is (26-30) according to MOCA. Patients having (21 to 42) score according to BBS. Exclusion Criteria: Fractures. Participants with recurrent stroke. Participants with sever spasticity Orthopedic or other neurological impairment that could influence balance.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
imran amjad
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sania aziz, MSNMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bacha khan medical complex
City
Swābi
State/Province
Kpk
ZIP/Postal Code
25000
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sania aziz, MSNMPT
Phone
03425086080
Email
sania.aziz@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
abdul mansor, MSnmpt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24259857
Citation
Chung EJ, Kim JH, Lee BH. The effects of core stabilization exercise on dynamic balance and gait function in stroke patients. J Phys Ther Sci. 2013 Jul;25(7):803-6. doi: 10.1589/jpts.25.803. Epub 2013 Aug 20.
Results Reference
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PubMed Identifier
26451007
Citation
Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.
Results Reference
background
PubMed Identifier
28351168
Citation
Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.
Results Reference
background
PubMed Identifier
34358276
Citation
Chiu HL, Yeh TT, Lo YT, Liang PJ, Lee SC. The effects of the Otago Exercise Programme on actual and perceived balance in older adults: A meta-analysis. PLoS One. 2021 Aug 6;16(8):e0255780. doi: 10.1371/journal.pone.0255780. eCollection 2021.
Results Reference
background
PubMed Identifier
18795987
Citation
Liu-Ambrose T, Donaldson MG, Ahamed Y, Graf P, Cook WL, Close J, Lord SR, Khan KM. Otago home-based strength and balance retraining improves executive functioning in older fallers: a randomized controlled trial. J Am Geriatr Soc. 2008 Oct;56(10):1821-30. doi: 10.1111/j.1532-5415.2008.01931.x. Epub 2008 Sep 15.
Results Reference
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Comparison of Core Stability and Otago Exercise on Balance and Quality of Life in Patients With Stroke

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