StrokeNCT03053154
Relationship Between Pelvic Tilt and Sit to Stand Task in Stroke Patients
An observational study of Stroke, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess and determine the influence of pelvic inclination on sit to stand task in stroke patients. Read more about this study
- Who is it for?
- Ages 45 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Sagittal pelvic tilt assessment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2016to Mar 2017
- Phase
- Observational
- 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 45 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Sagittal pelvic tilt assessment
- Keywords
- Pelvic Inclination, Sit to Stand, Stroke, Anterior pelvic tilt, Posterior pelvic tilt
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sagittal pelvic tilt assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sagittal pelvic tilt assessment | |
| 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. Receives: Other: Sagittal pelvic tilt assessment | |
| 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. Receives: Other: Sagittal pelvic tilt assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
posterior pelvic tilt angle
Posterior pelvic tilt angle measured by the palpation meter (PALM) inclinometer. It was assessed as one shot in one assessment session.
Measured: One shot (Each participant was assessed immediately and it takes about 15 minutes)
Secondary outcomes (1)
Pelvic Inclination analysis in sit to stand task
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.
Measured: One shot (Each participant is assessed immediately and it takes about 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startSep 2016
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manar El-sayed Ismail, Cairo University
- Investigators
- Manar El-sayed Ismail, Cairo UniversityMoshera H. Darwesh, Professor, Cairo UniversitySandra M. Ahmed, Assistant Professor, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053154
- Sponsor's protocol ID
- P.T.REC/012/001363
- Status last verified
- May 2017
- First submitted
- 22 Jan 2017
- Last updated
- 15 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence Of Pelvic Inclination On Sit To Stand Task In Stroke Patients
- ClinicalTrials.gov ID
- NCT03053154
- Acronym / sponsor ID
- P.T.REC/012/001363
- Conditions
- Stroke
- Keywords
- Pelvic Inclination, Sit to Stand, Stroke, Anterior pelvic tilt, Posterior pelvic tilt
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess and determine the influence of pelvic inclination on sit to stand task in stroke patients.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group1 | – | Other: Sagittal pelvic tilt assessment15 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. |
| Experimental group2 | – | Other: Sagittal pelvic tilt assessment15 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. |
| Control group | – | Other: Sagittal pelvic tilt assessment15 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. |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sagittal pelvic tilt assessmentEach 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. | Other | Control group, Experimental group1, Experimental group2 |
Primary outcome
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.
1 secondary outcome
Pelvic Inclination analysis in sit to stand task
Time frame: One shot (Each participant is assessed immediately and it takes about 10 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manar El-sayed Ismail
Cairo University
Moshera H. Darwesh, Professor
Cairo University
Sandra M. Ahmed, Assistant Professor
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Cairo University at 1 site in Egypt.
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 8 inclusion and 5 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 15 May 2017. 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 Egypt. 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?
posterior pelvic tilt angle (time frame: One shot (Each participant was assessed immediately and it takes about 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 May 2017.