Core Stability, Symmetrical Weight-bearing Stroke

February 16, 2024 updated by: Mohamed Arafa Abdel Halim, Cairo University

Effect of Core Stability Exercise on Symmetrical Weight Bearing in Chronic Stroke Patient

To evaluate the effect of core stability exercise on symmetrical weight bearing in chronic stroke patients?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Stroke is a syndrome characterized by quickly emerging clinical indicators of a focal (or global) disruption of brain function. The symptoms can last for more than 24 hours or even result in death, and there is no known reason for them other than vascular origin. Over 80% of all strokes are caused by an ischemic stroke. A large artery blockage typically results in tissue infarction, which is the non-selective loss of all brain cells in the affected areas of the brain if it is not quickly reversed. Determining the location and size of these infarcts is crucial. the long-term functional deficits resulting from ischemic stroke. After a stroke, patients' ability to bear weight symmetrically is similarly compromised; they may bear between 61 and 80% of their body weight on a non-paretic leg. Physiotherapy procedures targeted at enhancing core stability can enhance the lumbopelvic-hip musculature's strength, coordination, and endurance, potentially reducing physical deficits linked to compromised trunk function. Because these muscles are crucial for both stability and lumbar posture control (by the employment of Core stability is commonly utilized in whole-body exercises to enhance the strength of the muscles around the stomach, lumbar, and pelvic regions, whether they be tonic or postural muscles. The trunk is the body's center pivot point, serving as a vital component for functional activity, balance, postural control, and extremity coordination. Consequently, the trunk is very important. in the recovery procedure. There is a substantial body of research demonstrating that Trunk control, balance when sitting and standing, and mobility can all be improved with trunk training. in stroke patients, according to recent studies in systemic reviews. So, the purpose of the current study was to detect the effect of core stability exercise on symmetrical weight bearing in patients with chronic stroke

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Forty hemiparetic patients were diagnosed and referred to by a neurologist.
  2. All patients must be ambulant
  3. The spasticity of lower limbs ranges from (grade 1: 1+) according to Modified Ashworth Scale.
  4. Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental Scale >24). (
  5. Age ranges from 50 to 65 years in both sexes.
  6. Duration of stroke was more than 6 months up to 24 months. -

Exclusion Criteria:

  • The patients were excluded if they had any of the following:

    1. Musculoskeletal disorders such as severe arthritis grade (3-4) of osteoarthritis, lower limb fractures less than 6 months or contractures of fixed deformity.
    2. Cognitive impairment (a score less than 24 according to the MMSE)
    3. Patients with diabetic neuropathy.
    4. Recurrent stroke.
    5. Rheumatologic or endocrinologic disorders that may cause ROM restriction.
    6. Patients suffering from cognitive, or emotional disturbance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: study group

Core stability Exercises. Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program).

+ Selected physical therapy program.
Other: core stability exercise
Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program).
Other: control group
Selected physical therapy program. all participants in both groups (A & B) had three sessions per week for a month and a half, every other day. of Selected physical therapy program which consist of (Exercises for tone modulation, balance, lower limb muscular strengthening, and stretching)
Other: core stability exercise
Each participant in the group (A) underwent eighteen sessions of core stability exercises very other day for one and half months, 3 sessions /week, each session for 1hour (30 minutes for core exercises then 30 minutes Selected physical therapy program).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Each patient was assessed by Balance Berg scales pretreatment. and repeated Measurements were taken after treatment. Each patient was assessed by Digital weight scale and Balance Berg scales
Time Frame: six weeks
The Berg Balance Scale (BBS) was used to assess static and dynamic balance
six weeks
Each patient was assessed by Digital weight scale pre treatment and repeated Measurements were taken after treatment.
Time Frame: 6 week
Digital weight scale:
6 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 20, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Core Stability

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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