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StrokeNCT05591378

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

A study testing core stability exercises and otago exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Stroke
What is being tested?
core stability exercises and otago exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 sitePakistan
Study dates
20 Nov 2022to 15 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Bacha khan medical complex

    Swābi, Kpk, 25000

Other trials in Pakistan

About this study

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.

Read the 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.

Conditions
Stroke
Being tested
core stability exercises, otago exercises
Keywords
balance, quality of life, stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • core stability exercisesOther

    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

  • otago exercisesOther

    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

Study groups in NCT05591378
Study groupRoleWhat they receive
core stability exercisesExperimentalimprove balance and muscle strengthening
Receives: Other: core stability exercises
otago exercisesExperimentalimprove balance and quality of life
Receives: Other: otago exercises

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 week

Secondary outcomes (2)

  1. 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. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.

    Measured: 8 week

  2. 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.

    Measured: 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start20 Nov 2022
  3. Primary completion15 Apr 2023
  4. Study completion15 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591378
Sponsor's protocol ID
abdul mansoor
Status last verified
May 2024
First submitted
21 Sep 2022
Last updated
21 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 24259857

  • 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.

    PubMed 26451007

  • 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.

    PubMed 28351168

  • 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.

    PubMed 34358276

  • 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.

    PubMed 18795987

Questions about this trial

What is this clinical trial studying?

A study testing core stability exercises and otago exercises in people with Stroke, run by Riphah International University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg balance scale (time frame: 8 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05591378, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2024.

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