- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05707065
Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques in Chronic Stroke Patients
January 30, 2023 updated by: Riphah International University
Comparative Effects of Core Strengthening Versus Lower Limb Proprioceptive Neuromuscular Facilitation Techniques on Trunk Function and Balance in Chronic Stroke Patients
Stroke is a global healthcare issue that causes increased death rates.
Good trunk stability is essential for balance and extremity use during daily functional activities and higher-level tasks.
The anticipatory activity of trunk muscles is impaired in stroke patients.
The trunk is the central column of the body; therefore, proximal trunk control is a prerequisite for distal limb movement control, balance, and functional activities.
The purpose of the study is to highlight the most appropriate rehabilitation technique for trunk stability.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
A randomized clinical trial will be performed in which 42 patients with strokes will be included.
The data will be collected from Riphah Rehabilitation center Lahore and Ittefaq hospital Lahore.
Consecutive sampling technique will be used to collect data.
The duration of the study will be 10 months.
Trunk impairment scale and berg balance scale will be used as the data collection tool.
Data collection will be started after taking informed consent from all the patients.
Patients will be allocated to intervention groups by randomization.
The patients in group A will be given core strengthening exercise for 4 weeks.
The patient in group B will be given PNF exercise for the treatment of trunk for 4 weeks.
After data collection analysis of pre and post values will be done by using SPSS version 25.
Study Type
Interventional
Enrollment (Anticipated)
42
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 Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54700
- Recruiting
- Ittefaq Hospital
-
Sub-Investigator:
- Ali Raza, Ms(OMPT)
-
Contact:
- Ali Raza, MS(OMPT)
- Phone Number: 03326099065
- Email: araza.frahs@riphah.edu.pk
-
Principal Investigator:
- Muhammad Hanif, MsPT(NMPT)
-
-
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
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Chronic stroke patients (6 months to 2 years).
- Participants with first ever ischemic stroke of right or left half of the body.
- Participants should be able to walk without support for 10 m.
- MMSE score is ≥ 24.
Exclusion Criteria:
- Participants with recurrent stroke; brainstem or cerebellar stroke or hemorrhagic stroke will be excluded.
- Patients with speech problem after stroke
- Patients with other neurological disorders including: Parkinson's disease, multiple sclerosis, epilepsy, etc.
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
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: core strengthening exercises
Participants will be positioned in supine.
|
The core muscles training includes transverse abdominis, multifidus, paraspinals, quadratus lumborum, and obliques.
|
|
EXPERIMENTAL: Proprioceptive Neuromuscular Facilitation
Total 30 min for 3 days a week for a total duration of 4 weeks was set as a optimal time frame duration. Each technique was given for 10 min. |
lower limb PNF technique along with conventional treatment i.e., Rhythmic initiation, slow reversal, stabilizing reversal, and combination of isotones.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Berg balance scale
Time Frame: 4th week
|
Changes from baseline Berg balance scale 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 and takes approximately 20 minutes to complete.
It does not include the assessment of gait.
|
4th week
|
|
Trunk Impairment Scale (TIS)
Time Frame: 4th week
|
Changes from baseline TIS is a new tool to measure motor impairment of the trunk after stroke.
The TIS evaluates static and dynamic sitting balance as well as co-ordination of trunk movement.
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ali Raza, MS(OMPT), Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.
- Park SE, Moon SH. Effects of trunk stability exercise using proprioceptive neuromuscular facilitation with changes in chair height on the gait of patients who had a stroke. J Phys Ther Sci. 2016 Jul;28(7):2014-8. doi: 10.1589/jpts.28.2014. Epub 2016 Jul 29.
- Suh JH, Lee EC, Kim JS, Yoon SY. Association between trunk core muscle thickness and functional ability in subacute hemiplegic stroke patients: an exploratory cross-sectional study. Top Stroke Rehabil. 2022 Apr;29(3):163-172. doi: 10.1080/10749357.2021.1918840. Epub 2021 Apr 26.
- Asghar M, Fatima A, Warner S, Khan MHU, Ahmad A, Siddique K. Effectiveness of proprioceptive neuromuscular facilitation on balance in chronic stroke patients. Rawal Medical Journal. 2021;46(1):212-5
- Krukowska J, Bugajski M, Sienkiewicz M, Czernicki J. The influence of NDT-Bobath and PNF methods on the field support and total path length measure foot pressure (COP) in patients after stroke. Neurol Neurochir Pol. 2016 Nov-Dec;50(6):449-454. doi: 10.1016/j.pjnns.2016.08.004. Epub 2016 Aug 20.
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)
January 1, 2023
Primary Completion (ANTICIPATED)
March 15, 2023
Study Completion (ANTICIPATED)
March 22, 2023
Study Registration Dates
First Submitted
January 22, 2023
First Submitted That Met QC Criteria
January 30, 2023
First Posted (ACTUAL)
January 31, 2023
Study Record Updates
Last Update Posted (ACTUAL)
January 31, 2023
Last Update Submitted That Met QC Criteria
January 30, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0217
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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
-
University of Illinois at ChicagoRecruitingStroke, Ischemic | Stroke Hemorrhagic | Stroke, CerebrovascularUnited States
-
IRCCS San Camillo, Venezia, ItalyRecruitingStroke | Stroke, Ischemic | Stroke Sequelae | Stroke HemorrhagicItaly
-
Fondazione Don Carlo Gnocchi OnlusScuola Superiore Sant'Anna di Pisa; Fondazione Policlinico Universitario Campus...Not yet recruitingStroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke IschemicItaly
Clinical Trials on core strengthening exercises
-
King Saud UniversityCompleted
-
Riphah International UniversityCompleted
-
Riphah International UniversityRecruitingLow Back Pain | Hydrotherapy | Resistance Training | Core StabilityPakistan
-
Riphah International UniversityCompleted
-
Cairo UniversityRecruiting
-
University of Health Sciences LahoreCompletedNon-specific Low Back Pain (NSLBP)Pakistan
-
Istanbul University - Cerrahpasa (IUC)Not yet recruitingParkinson Disease | Gait Disorders, Neurologic | Respiration
-
Riphah International UniversityCompleted
-
University of LahoreRecruitingStroke; ParalysisPakistan