- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598487
Comparative Effects of PNF (Rhythmic Stabilization With Stabilizing Reversal) and NDT (Facilitatory Techniques) on Trunk Control in Sub-Acute Stroke
A stroke is a serious cerebrovascular accident defined as the sudden onset of a neurological deficit caused by vascular changes. Stroke are classified into primarily two types; ischemic and hemorrhagic stroke. In an ischemic stroke, there is an inadequate blood supply to the central nervous system, whereas a hemorrhagic stroke involves a blood vessel rupture and subsequent blood accumulation. Stroke is the fifth leading cause of death and primary cause of severe disability. In hemiplegic patient, trunk impairment is frequently present due to muscular weakness. Furthermore, it can lead to severe functional impairments and reduce a patient's quality of life. Severe complications will occur, if left untreated these complications can lead to functional dependency. Trunk muscular activity is delayed in stroke patient, muscles involved in reaching activity of upper limb activates earlier than the trunk muscles themselves. Trunk muscles play a unique role in maintaining upright posture during sitting, standing and they are important for stabilizing proximal body parts during voluntary limb movements. Patients with hemiparesis often struggle to move their trunk against gravity, regardless of the specific muscle activity required.
Different treatment approaches are used to manage trunk stability in stroke patients with Proprioceptive Neuromuscular Facilitation and Neurodevelopmental Facilitatory Techniques being two of the most common techniques in neurorehabilitation. Proprioceptive Neuromuscular Facilitation technique (PNF) is a well- established approach used to improve functional movement through facilitation, strengthening and lengthening of muscle groups. Neurodevelopmental treatment focuses on the patient's active participation to improve motor control. The aim of this study is to compare the effects of PNF (Rhythmic Stabilization with Stabilizing Reversal) and NDT (Facilitatory Techniques) on trunk control in subacute stroke patients. Thirty- two participants having age 40-65years, hemiparesis, Middle Cerebral Artery Stroke will be included. Patients with recurrent stroke, impaired cognition, severe cerebellar ataxia, severe language deficit and severe musculoskeletal disorders will be excluded.
Electrical stimulation will be given as a baseline treatment for 10-15 minutes on hemiparesis side. Group A will receive PNF facilitation along with the baseline
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treatment. Group B will receive Neurodevelopmental facilitation techniques in addition to the baseline treatment. Specific clinical tools will be used to assess trunk mobility in stroke survivors. Trunk Impairment Scale (TIS) will be used to evaluate motor rearrangement and provide clinicians with information regarding the quality of trunk movements and stability. Modified Functional Reach Test (MFRT) is reliable test for stroke survivors with impaired trunk mobility. It will be used to evaluate the participants ability to maintain dynamic sitting balance. Data will be analyzed using SPSS (2023 version). Statistical test will be selected based on data normality. If the data will be normally distributed, independent and paired t- test will be applied. If data will be not normal, then Wilcoxon Signed Rank and Mann Whitney U test will be utilized.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Faisalabad, Punjab Province, Pakistan, 38000
- Madinah Teaching Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both males and females will be eligible for this study. Patient diagnosed with an ischemic stroke involving the Middle Cerebral Artery resulting in hemiparesis will be included. Participants with significant trunk instability, defined by a score of less than 21 on the Trunk Impairment Scale will be included.
Exclusion Criteria:
Those presenting with recurrent stroke and severe cardiovascular instability will be excluded from the study.
Patients with co-existing neurological disorders or severe cerebellar lesion will be excluded from the study.
Individuals with significant cognitive deficit or language impairments that hinder the ability to follow simple instructions will be excluded from the study.
Patients with severe pre-existing musculoskeletal pathologies will be excluded from the study.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Group A PNF (Rhythmic Stabilization with Stabilizing Reversal techniques)
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Baseline: Electrical Muscle Stimulation for a duration of 10-15 minutes Group A-Proprioceptive Neuromuscular Facilitation (PNF) Participants will receive baseline treatment combined with particular proprioceptive neuromuscular facilitation techniques, including Rhythmic Stabilization and Stabilizing Reversal.
Both techniques are known to engage deep trunk muscles, which contributes to symmetrical movement pattern and better postural control.
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Experimental: Group B NDT (Facilitatory Techniques)
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Group B will be treated with baseline EMS for a duration of 10-15 minutes.
alongside various facilitatory techniques designed to restore trunk function.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk control
Time Frame: 8 weeks
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Trunk impairment scale (TIS) is a highly trusted clinical resource used to measure core stability in stroke survivors, especially during the vital subacute stroke recovery period.
This tool breaks down core function into three key areas; how well a patient sit still, how they move while seated and how coordinated their torso is.
Since, core strength is the foundation for almost every movement (from sitting upright to (walking) a low score on the TIS often highlights why a patient might struggle with mobility and balance.
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Functional Reach Test (MFRT)
Time Frame: 8 weeks
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Modified Functional Reach Test (MFRT) is reliable test for stroke survivors with impaired trunk mobility.
It will be used to evaluate the participants ability to maintain dynamic sitting balance and trunk control.
While based on the original Functional Reach Test, the MFRT is specifically adapted for patients who lack the ability to stand unaided.
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8 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TUF/EIRB/167/26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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