Effects of Whole Body Vibration Versus Proprioceptive Neuromuscular Facilitation Pattern With Rhythmic Based Training on Clinical Outcomes in Patients With Parkinson's Disease.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Shakargarh, Punjab Province, Pakistan, 51580
- THQ Shakargarh
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Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 40 and 60 years.
- Patients of both genders (male and female).
- Parkinson's disease severity at Hoehn and Yahr (H&Y) stage 2 and 3.
- Ability to walk independently for 6 minutes without an assistive device.
- Score greater than 40 on the Berg Balance Scale.
Exclusion Criteria:
- Presence of impaired Cognition.
- Significant Orthopedic and Musculoskeletal conditions that limit the adherence to exercise and WBV requirements.
- Other medical conditions like thrombosis, cardiovascular conditions and medical implants that are contradicted for WBV.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
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Experimental: Whole Body Vibration with Rhythmic Based Training
Whole Body Vibration (WBV) and Rhythm-Based Training (RBT) are adjunct therapeutic interventions used to enhance functional mobility, balance, and motor coordination.
WBV provides mechanical oscillatory stimuli to the body through a vibration platform, aiming to improve neuromuscular activation and postural control.
RBT utilizes external auditory cues to guide movement timing, promoting auditory-motor entrainment and improving movement coordination and gait performance.
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WBV will be applied during standing exercises using a vibration platform set at a frequency of 11 Hz and an amplitude of 3-6 mm (vertical oscillation).
The intervention will be administered in intermittent cycles of 1 minute of vibration followed by 1 minute of rest, with a total cumulative exposure of 10-14 minutes per session (5-7 bouts).
Concurrently, RBT will be delivered using an auditory metronome providing rhythmic cues synchronized with the exercise movements, with the tempo maintained between 110-130 beats per minute (BPM) to facilitate timing, coordination, and motor performance.
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Experimental: Proprioceptive Neuromuscular Facilitation Pattern with Rhythmic Based Training
Proprioceptive Neuromuscular Facilitation (PNF) Rhythmic Initiation (RI) D1 patterns combined with Rhythm-Based Training (RBT) are used to facilitate motor learning, improve movement initiation, and enhance neuromuscular coordination.
The D1 flexion and extension patterns of PNF target coordinated multi-planar upper and lower limb movements, progressing through passive, active-assisted, and active-resistive phases to improve motor control, normalize muscle tone, and increase movement efficiency.
RBT provides external auditory cueing to enhance timing and rhythmic synchronization of voluntary movement.
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The patient will perform PNF Rhythmic Initiation (RI) D1 flexion and extension patterns for both upper and lower extremities in standing.
The D1 flexion pattern involves shoulder extension, abduction, and external rotation progressing to flexion, adduction, and internal rotation, while the D1 extension pattern represents the reverse movement.
The exercise will be progressed from passive to active-assisted and then to active-resistive movements to facilitate motor control and movement initiation.
In addition, Rhythm-Based Training (RBT) will be applied using an auditory metronome to provide rhythmic cues synchronized with the active phase of the PNF movements, particularly during transitions between flexion and extension, with a consistent tempo of 110-130 beats per minute (BPM).
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Timed Up and Go (TUG) Test
Time Frame: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Timed Up and Go (TUG) test is a simple functional mobility assessment that measures the time taken (in seconds) to stand from a chair, walk 3 meters, turn, walk back, and sit down.
It evaluates balance, gait, and functional mobility in a single task.
Lower scores indicate better performance, with <10 seconds considered normal, 10-20 seconds indicating mostly independent mobility, and >20 seconds suggesting functional limitation.
It is also commonly used as an indicator of fall risk, especially in neurological populations such as Parkinson's disease.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)
Time Frame: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Unified Parkinson's Disease Rating Scale (UPDRS-III) is a clinician-administered tool used to evaluate motor impairment in Parkinson's disease.
It assesses key motor domains including tremor, rigidity, bradykinesia, posture, gait, and postural stability through direct observation.
Each item is scored on a 0-4 scale, where 0 represents normal function and 4 indicates severe impairment, with a maximum total score of 132.
Higher scores reflect greater motor dysfunction.
The scale is widely used for monitoring disease severity and progression in both clinical and research settings.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Mini-Balance Evaluation Systems Test (Mini-BESTest)
Time Frame: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The Mini-BESTest is a clinical balance assessment designed to evaluate dynamic balance and postural control across multiple systems, including anticipatory postural adjustments, reactive postural control, sensory orientation, and gait stability.
It consists of 14 items scored from 0 to 2, with a total score ranging from 0 to 28, where higher scores indicate better balance performance.
It is particularly sensitive in detecting balance impairments and fall risk in individuals with neurological conditions such as Parkinson's disease.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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10-Meter Walk Test (10MWT)
Time Frame: [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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The 10-Meter Walk Test (10MWT) is a standardized measure of gait speed, where the time taken to walk a central 10-meter distance is recorded and converted into meters per second (m/s).
It assesses functional walking ability and mobility performance.
The test can be performed at a comfortable or fast pace to evaluate functional capacity.
It is widely used in Parkinson's disease to monitor gait impairments and response to rehabilitation, as gait speed is a strong indicator of overall functional status.
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[Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]
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Collaborators and Investigators
Sponsor
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- UBAS/ERB/26/04/038
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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