NCT07723027

Brief Summary

This study has important clinical, academic, and practical relevance in neuromuscular rehabilitation. Clinically, it aims to identify effective and tolerable rehabilitation strategies for individuals with Parkinson's disease by comparing whole-body vibration therapy with proprioceptive neuromuscular facilitation (PNF) patterns combined with rhythmic-based training, thereby supporting evidence-based physiotherapy practice and improving patient adherence. Academically, it contributes to the limited literature on comparative effectiveness of these interventions and incorporates patient-centered outcomes such as exercise perception, which are often underreported. From a practical and societal perspective, identifying a more acceptable and effective approach may enhance long-term participation in rehabilitation, potentially slow disease progression, improve quality of life, and reduce the overall healthcare burden associated with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 9, 2026

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Keywords

Whole Body VibrationProprioceptive Neuromuscular Facilitation PatternRhythmic Based TrainingClinical Outcomes

Outcome Measures

Primary Outcomes (4)

  • Timed Up and Go (TUG) Test

    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.

    [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]

  • Unified Parkinson's Disease Rating Scale - Part III (UPDRS-III)

    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.

    [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]

  • Mini-Balance Evaluation Systems Test (Mini-BESTest)

    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.

    [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]

  • 10-Meter Walk Test (10MWT)

    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.

    [Time Frame: baseline, 8 weeks (post intervention), 12 weeks (follow up)]

Study Arms (2)

Whole Body Vibration with Rhythmic Based Training

EXPERIMENTAL

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.

Other: Whole Body Vibration with Rhythmic Based Training

Proprioceptive Neuromuscular Facilitation Pattern with Rhythmic Based Training

EXPERIMENTAL

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.

Other: Proprioceptive Neuromuscular Facilitation Pattern with Rhythm-Based Training

Interventions

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.

Whole Body Vibration with Rhythmic Based Training

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).

Proprioceptive Neuromuscular Facilitation Pattern with Rhythmic Based Training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

THQ Shakargarh

Shakargarh, Punjab Province, 51580, Pakistan

Location

Related Publications (1)

  • Chang CM, Tsai CH, Lu MK, Tseng HC, Lu G, Liu BL, Lin HC. The neuromuscular responses in patients with Parkinson's disease under different conditions during whole-body vibration training. BMC Complement Med Ther. 2022 Jan 3;22(1):2. doi: 10.1186/s12906-021-03481-1.

    PMID: 34980075BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
outcome assessor will be blind about participants allocation; this will ensure that their evaluations are objective and not influenced by knowledge of which treatment group participants belong to. Participants in both groups will be masked to the treatment of the other group by scheduling their sessions at different times.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study will use a parallel-group randomized clinical design, with participants randomly allocated into two intervention groups. Group A will receive Whole Body Vibration (WBV) combined with Rhythm-Based Training (RBT), where participants perform standing exercises such as weight shifting and mini-squats on a vibrating platform at 11 Hz frequency and 3-6 mm amplitude, applied in 1-minute bouts with 1-minute rest intervals for a total of 10-14 minutes. Rhythmic auditory cueing using a metronome set at 110-130 BPM will be provided concurrently or prior to enhance coordination and movement timing, with sessions conducted 2-3 times per week. Group B will receive Proprioceptive Neuromuscular Facilitation (PNF) using Rhythmic Initiation D1 flexion and extension patterns in standing, progressing from passive to active and resistive movements, structured in 1-minute work and rest intervals, with integrated rhythmic cueing at 110-130 BPM to improve motor control and functional performance.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

May 1, 2026

Primary Completion

July 9, 2026

Study Completion

July 9, 2026

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations