NCT05644847

Brief Summary

Spinal proprioception is integral for maintaining trunk stability during the performance of both static and dynamic tasks. Proprioceptive feedback contributes towards joint position sense and postural stability. Several treatment approaches are available for improving proprioception, one such modality is whole body vibration. The evidence supporting the effectiveness of WBV in improving postural stability is scarce. Moreover, the population of interest for this study is healthy adults because this age group is often neglected in the research related to balance and postural stability however incidence of falls in this age group is high as per latest evidence. The aim of this study is to compare the effect of whole-body vibration along with core stability training versus core stability training alone on lumbar proprioception and postural stability in healthy adults.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 9, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2023

Completed
Last Updated

December 9, 2022

Status Verified

November 1, 2022

Enrollment Period

5 months

First QC Date

November 30, 2022

Last Update Submit

November 30, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Lumbar Proprioception/ Lumbar Joint Position Sense Test

    Lumbar Proprioception/ Lumbar Joint Position Sense Test will be measured using inclinometer having excellent validity and reliability. Two inclinometers will be used simultaneously for measuring the flexion and extension ROM. Repositioning accuracy will be assessed with participants trying to reproduce the target position. Active repositioning error i.e. the difference between a target position and the reached position of the patient will be measured. A higher repositioning error indicates poor joint position sense or proprioception.

    04 Weeks

Secondary Outcomes (1)

  • Postural Stability

    04 Weeks

Study Arms (2)

Group A (Core Stability Training Group)

ACTIVE COMPARATOR

Participants in the control group/ core stability training group will be instructed to perform core stability exercises which will include pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats, with 60 seconds rest intervals between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets weekly. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises. A total of 12 sessions will be conducted over a period of 04 weeks.

Procedure: Core Stability Training

Group B (Whole body Vibration Training Group)

EXPERIMENTAL

Participants in the dynamic WBV group will be provided with dynamic exercises along with WBV training at 50 Hz frequency. Participants will be instructed to perform 1-3 sets of 5-12 repetitions each of pelvic bridge, straight leg bridge, modified kneeling with elbow support, and leg lifts and squats on the WBV equipment, with a 60-second rest interval between each activity. The vibration speed and no. of sets and repetitions will be increased progressively. A total of 12 sessions will be conducted over a period of 04 weeks.

Other: Whole Body Vibration TrainingProcedure: Core Stability Training

Interventions

WBV training will be performed on a commercial vibrating platform (Healthmate HM01-08VF Gym Fitness Equipment Step Vibration Machine, China), which produces vertical sinusoidal vibrations. Participants in the dynamic WBV group will be provided with dynamic exercises along with WBV training. The vibration speed level will be progressed from level 5 to level 10 during the course of the treatment sessions

Group B (Whole body Vibration Training Group)

Core stability exercises will include pelvic bridge, straight leg bridge, modified kneeling with elbow support and leg lifts and squats, with 60 seconds rest interval between each activity. All these core exercises will be performed on a stable surface and will be progressed in difficulty by increasing the no. of repetitions and no. of sets on a weekly basis. Every session will be preceded by 5 minutes of warm-up and end with 5 minutes of cool-down exercises.

Group A (Core Stability Training Group)Group B (Whole body Vibration Training Group)

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young adults aged 18-25 years
  • Both males and females willing to participate in the study
  • No participation in a regular exercise or physical activity program
  • Subjects with fall risk score (FRS) \> 1.5 on Biodex balance system

You may not qualify if:

  • Individuals suffering from any acute or chronic co-morbidities of musculoskeletal, neurologic, cardiovascular or systemic origin
  • Subjects with history of low back pain or any vestibular disorders, inner ear infections, or hearing loss, which could affect balance and proprioception
  • Pregnant females

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fauji Foundation Hospital Department of Rehabilitation

Rawalpindi, Punjab Province, Pakistan

RECRUITING

Central Study Contacts

Muhammad Ali Tareen, MS*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessor will be a another person who will be unaware of the group the participant belongs to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single Blinded Parallel Randomised controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2022

First Posted

December 9, 2022

Study Start

August 1, 2022

Primary Completion

December 30, 2022

Study Completion

January 30, 2023

Last Updated

December 9, 2022

Record last verified: 2022-11

Locations