- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06067724
Effect of Pelvic Control Exercises in Stroke
April 5, 2024 updated by: Rowida Abd Elgleel Sayed Abd Elgleel, Cairo University
Effect of Pelvic and Trunk Control Exercises on Function Outcome of Affected Upper Extremity in Stroke Patients
The purpose of the study is to investigate the combined effect of pelvic and trunk control exercises on muscle performance of affected upper extremity in stroke patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
The study conducted on forty stroke patients.
They assessed by Biodex System 3 Pro Isokinetic, Modified Ashworth Scale(MAS), Fugel Meyer Assessment scale (FMAS), Box and block test and hand grip dynamometer.
Patients divided into control group and study group.
The control group treated by a traditional physical therapy program.The study group treated by the traditional physical therap program in addition to pelvic and trunk control exercises for 40 min.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- 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 Contact
- Name: Rowida Abdelgleel, Assistant lecturer
- Phone Number: 01152322678
- Email: rowidaabdelglel@gmail.com
Study Contact Backup
- Name: Nahed Salem, Professor
- Phone Number: +201224297063
- Email: nahedsalem960@gmail.com
Study Locations
-
-
-
Giza, Egypt, 12612
- Recruiting
- Faculty of Physical Therapy labs at Cairo University
-
Contact:
- Rowida Abdelgleel, Assistant lecturer
- Phone Number: 01152322677
- Email: rowidaabdelglel@gmail.com
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patient's age will range from 45 - 60 years.
- Muscle tone grade will range from 1 to 1+ according to modified Ashworth scale.
- Duration of illness will range from 6 to 18 months after stroke onset.
- Ability of the patient to stand without assistive devices.
Exclusion Criteria:
• Other neurological or musculoskeletal disorders that might affect pelvic alignment such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures, contractures of fixed deformity or leg length discrepancy.
- Severe chronic back and/or knee pain that might affected standing posture.
- Recurrent stroke
- Shoulder or upper limb injury that might affect the recovery.
- Perceptual or cognitive dysfunctions.
- BMI > 30
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Pelvic and trunk control exercises
Twenty Egyptian male stroke patients will receive 40 minutes of pelvic and trunk control exercises for six weeks after a 30 minutes of traditional physical therapy program.
|
Patients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic and trunk control exercises for 40 min included abdominal drawing in maneuver for contraction of transversus abdominis pelvic tilting exercises and pelvic stabilization exercises from different positions.
Pelvic tilting exercises included; anterior, posterior, lateral pelvic tilting and pelvic rotation on a therapeutic ball.
Pelvic stabilization exercises include bridging, half bridging, clamshell from supine and side lying, quadribed exercises, weight shifting on the affected limb from standing by forward and diagonal reach out, ball bridging and rhythmic stabilization exercises
|
|
Sham Comparator: Traditional physical therapy
Twenty Egyptian male stroke patients will receive 30 minutes of sham traditional physical therapy program for six weeks.
|
Patients in this group will be treated by the traditional physical therapy program in addition to a 18 sessions of pelvic and trunk control exercises for 40 min included abdominal drawing in maneuver for contraction of transversus abdominis pelvic tilting exercises and pelvic stabilization exercises from different positions.
Pelvic tilting exercises included; anterior, posterior, lateral pelvic tilting and pelvic rotation on a therapeutic ball.
Pelvic stabilization exercises include bridging, half bridging, clamshell from supine and side lying, quadribed exercises, weight shifting on the affected limb from standing by forward and diagonal reach out, ball bridging and rhythmic stabilization exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biodex System 3 Pro Isokinetic
Time Frame: Six weeks after the beginning of the intervention
|
Changes in peak muscle torque of upper limb muscles from baseline to four weeks after the beginning of intervention
|
Six weeks after the beginning of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fugl-Meyer Assessment for upper extremity
Time Frame: Six weeks after the beginning of the intervention
|
Changes in upper limb function from baseline to four weeks after the beginning of intervention
|
Six weeks after the beginning of the intervention
|
|
Box and block test
Time Frame: Six weeks after the beginning of the intervention
|
Changes in gross hand function from baseline to four weeks after the beginning of intervention
|
Six weeks after the beginning of the intervention
|
|
Hand grip dynamometer
Time Frame: Six weeks after the beginning of the intervention
|
. Changes in hand grip strength from baseline to four weeks after the beginning of intervention
|
Six weeks after the beginning of the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 20, 2023
Primary Completion (Estimated)
April 1, 2024
Study Completion (Estimated)
April 7, 2024
Study Registration Dates
First Submitted
September 28, 2023
First Submitted That Met QC Criteria
September 28, 2023
First Posted (Actual)
October 5, 2023
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pelvic control in stroke
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.
Clinical Trials on Stroke
-
National Assembly ClinicBayero University Kano, NigeriaRecruitingStroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After StrokeNigeria
-
University of PittsburghRecruitingHemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, EmbolicUnited States
-
Mahidol UniversityNot yet recruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke SurvivorsThailand
-
Mahidol UniversityRecruitingIschemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke PatientThailand
-
University Hospital, GhentRecruitingStroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke HemorrhagicBelgium
-
Moleac Pte Ltd.Not yet recruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
-
Samsung Medical CenterCompletedChronic Stroke | Subacute Stroke | ExoskeletonSouth Korea
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
Clinical Trials on Pelvic and trunk control exercises
-
Riphah International UniversityRecruiting
-
Gulf Medical UniversityCompletedStrokes ThromboticUnited Arab Emirates
-
Lahore University of Biological and Applied SciencesRecruiting
-
MTI UniversityCompleted
-
Hacettepe UniversityActive, not recruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Universitat de LleidaHospital Clinic of Barcelona; Universidad Europea de Madrid; Universitat Internacional...CompletedCerebellar Ataxia | Spinocerebellar Degenerations | Hereditary AtaxiaSpain
-
Universiteit AntwerpenRehabilitation Hospital RevArteCompleted
-
Istanbul Medipol University HospitalActive, not recruiting
-
Gazi UniversityCompletedMultiple Sclerosis | Pelvic Floor Muscle Exercise | Neurogenic Bladder DisorderTurkey (Türkiye)