Relationship Between Pelvic Tilt and Sit to Stand Task in Stroke Patients

May 11, 2017 updated by: Manar El-sayed Ismail, Cairo University

Influence Of Pelvic Inclination On Sit To Stand Task In Stroke Patients

The purpose of this study is to assess and determine the influence of pelvic inclination on sit to stand task in 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

There is a crucial need to have a better understanding of effect of pelvic inclination on sit to stand activity and to know the important factors to be considered to improve the patients' treatment and performance. Forty five participants are recruiting to assess the pelvic tilt angles in stroke patients during sitting position and to analyze the influence of pelvic tilt angles on ability to perform sit to stand task during rising from a chair in stroke patients.

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.
Observational

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.
45

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
      • Giza, Egypt, 12211
        • Manar El-sayed Ismail

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

45 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

The patients were recruited from the Out-patient clinic for Neuromuscular Disorders and Its Surgery, Faculty of Physical Therapy, Cairo University and Out- patient clinic of El-kasr El-Aini Hospital, Faculty of Medicine, Cairo University

Description

Inclusion Criteria:

  • Patients' age ranged from 45-60 years old.
  • Normal body weight with a body mass index (BMI) ranged from 18.5 to 24.9 kg/m2.
  • Patients' had the ability to maintain sitting position without using any aids.
  • Patients' had the ability to stand from sitting five times independently.
  • Cooperative patients with ability to understand instructions and follow simple verbal commands.
  • The duration of illness was from six months to 2 years.
  • The degree of the paretic lower limb spasticity ranged between (1:1+) according to the Modified Ashworth Scale.
  • The degree of the paretic lower limb weakness was not less than grade 3 according to group muscle testing.

Exclusion Criteria:

  • History of previous strokes and other neurological disorders.
  • Visual, auditory and vestibular deficits.
  • Cognitive impairments and language deficits.
  • Leg length discrepancy is more than 0.5 cm.
  • Previous history of orthopedic conditions in back or lower limbs (e.g. low back pain, fractures, deformities and surgeries).

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Experimental group1
15 stroke patients with right side affection, their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.
Other: Sagittal pelvic tilt assessment
Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.
Experimental group2
15 stroke patients with left side affection, their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.
Other: Sagittal pelvic tilt assessment
Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.
Control group
15 Normal subjects without any diseases or dysfunctions , their age ranged form 45 to 60 were recruited to assess the pelvic tilt angles from sitting position and from the dynamic task of sit to stand.
Other: Sagittal pelvic tilt assessment
Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.

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
posterior pelvic tilt angle
Time Frame: One shot (Each participant was assessed immediately and it takes about 15 minutes)
Posterior pelvic tilt angle measured by the palpation meter (PALM) inclinometer. It was assessed as one shot in one assessment session.
One shot (Each participant was assessed immediately and it takes about 15 minutes)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pelvic Inclination analysis in sit to stand task
Time Frame: One shot (Each participant is assessed immediately and it takes about 10 minutes)
Pelvic Inclination analysis in sit to stand task by Two dimensional video based motion analysis in three phases of sit to stand task. It will be assessed as one shot in one assessment session.
One shot (Each participant is assessed immediately and it takes about 10 minutes)

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

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Manar El-sayed Ismail, Cairo university
  • Moshera H. Darwesh, Professor, Cairo university
  • Sandra M. Ahmed, Assistant Professor, 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

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.
September 1, 2016

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.
January 1, 2017

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.
March 1, 2017

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).
January 22, 2017

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 10, 2017

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 14, 2017

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.
May 15, 2017

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.
May 11, 2017

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.
May 1, 2017

More Information

Terms related to this study

Keywords

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.
  • P.T.REC/012/001363

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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