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CTRI Number  CTRI/2024/04/066127 [Registered on: 23/04/2024] Trial Registered Prospectively
Last Modified On: 08/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Whole-body vibration programme in athletes with chronic ankle instability. 
Scientific Title of Study   EFFECTS OF WHOLE BODY VIBRATION AND BALANCE TRAINING ON ATHLETES WITH CHRONIC ANKLE INSTABILITY A RANDOMIZED CONTROL TRIAL  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meet Sandeep Kasliwal 
Designation  PG Student 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy, PIMS (DU) 
Address  Sports Physiotherapy Department Pravara Institue of Medical Sciences, Dr. APJ Abdul Kalam College of Physiotherapy, PIMS (DU) Loni, Ahmadnagar, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  7387289353  
Fax    
Email  meetkasliwal1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Rakesh Kumar Sinha 
Designation  Head Of Department Sports Physiotherapy 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy, PIMS (DU) 
Address  Sports Physiotherapy Department Pravara Institue of Medical Sciences, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Ahmadnagar, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9799783783  
Fax    
Email  smartphysio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rakesh Kumar Sinha 
Designation  Head Of Department Sports Physiotherapy 
Affiliation  Dr. APJ Abdul Kalam College of Physiotherapy, PIMS (DU) 
Address  Sports Physiotherapy Department Pravara Institue of Medical Sciences, Dr. APJ Abdul Kalam College of Physiotherapy, Loni, Ahmadnagar, 413736

Ahmadnagar
MAHARASHTRA
413736
India 
Phone  9799783783  
Fax    
Email  smartphysio@gmail.com  
 
Source of Monetary or Material Support  
Dr. APJ Abdul Kalam College of Physiotherapy 
 
Primary Sponsor  
Name  Sports Physiotherapy Department Dr. APJAK COPT  
Address  Dr. APJ Abdul Kalam College of Physiotherapy, Pravara Institute of Medical Sciences, Loni, Ahmadnagar, 413736  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Meet Sandeep Kasliwal  Dr. APJ Abdul Kalam College of Physotherapy  Sports Physiotherapy Department Dr. APJ Abdul Kalam College of Physiotherapy Pravara Institute of Medical Sciences Loni
Ahmadnagar
MAHARASHTRA 		 7387289353

meetkasliwal1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S934||Sprain of ankle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Balance training.  Group B will use a balance ball (BOSU ball). Group B participants will perform the exercises on the balance ball. Participants in both groups will be asked to maintain balance on either leg or an affected leg while having eyes closed. Both training programs will be conducted respectively three times per week for 6 weeks and will consist of a 5-min warm-up exercise, a 15-min main exercise, and a 5-min cool-down exercise. The main exercise will be comprised of three exercise movements: a double-leg stance, a one-legged stance, and a tandem stance. Weeks 1–3 will consist of four sets of 45s exercises with a 40s rest interval between exercises, and weeks 4–6 will consist of five sets of 45s exercises with a 30s rest interval between exercises.  
Intervention  Whole Body Vibration in athletes with chronic ankle instability.  Groups A will perform the WBV exercises during the 6-week training programs, but Group A will use a Whole-Body Vibrator platform. Group A will perform the exercises while standing on the vibration platform, which operated at a frequency and amplitude of 5 Hz and 3 mm, respectively. Both training programs will be conducted respectively three times per week for 6 weeks and will consist of a 5-min warm-up exercise, a 15-min main exercise, and a 5-min cool-down exercise. The main exercise will be comprised of three exercise movements: a double-leg stance, a one-legged stance, and a tandem stance. Weeks 1–3 will consist of four sets of 45s exercises with a 40s rest interval between exercises, and weeks 4–6 will consist of five sets of 45s exercises with a 30s rest interval between exercises.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Athletes should have a history of at least one ankle sprain.
Lateral ankle instability of any-one leg with a severity score 24 measured using the Cumberland Ankle Instability Tool.
 
 
ExclusionCriteria 
Details  Acute ankle sprain.
Participants who are currently undergoing or have recently undergone specific interventions or treatments for ankle instability
Individuals who have experienced recent trauma or undergone surgery on the affected ankle
Individuals with significant cognitive impairments or conditions affecting decision-making abilities
Those with systemic disorders or medical conditions that could impact joint stability or neuromuscular function (e.g., rheumatoid arthritis, peripheral neuropathy).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment    
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Star Excursion balance test.
 		 Week 0 to Week 6
 
 
Secondary Outcome  
Outcome  TimePoints 
Stork balance stand test.  Week 0 to Week 6
 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   15/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Other (Terminated) 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

       INTRODUCTION

      Lateral ankle sprains are one of the most common sports injuries and often result in a decrease in neuromuscular control and loss of proprioception.

      Neuromuscular control helps maintain the functional stability of the ankle, whereas proprioception influences ankle joint position and sense of movement. Impairments in these functions cause reduced dynamic balance and reaction time of the ankle joint during exercise.

      An ankle sprain resulting in damage to the lateral ankle capsuloligamentous complex can cause sequelae, such as recurring ankle sprains. It decreases ankle function and causes a loose feeling, and this post-injury symptom is classified as chronic ankle instability (CAI).   

      Athletes with CAI may experience limited functionality in their lower extremities, which can impact their sports performance. Therefore, specific balance exercises for athletes with CAI are critical in rehabilitation and training programs and could effectively reduce the risk of ankle sprain during sports activities.

      Balance training is a progressive type of exercise performed on an unstable surface, and the resultant efferent output causes changes in α motor neuron excitability. Balance training was used to improve muscle excitability in the ankle joint and increase motor control for CAI.

      Whole-body vibration (WBV) training is another popular method used in CAI rehabilitation. WBV training was performed on an oscillating vibration platform, which activates muscle spindles to facilitate the tonic vibration reflex. This training also enhances motor neuron excitability and the synchronization of motor units to increase motor control in the ankle. To the best of our knowledge, there have only been a few studies comparing the effects of WBC and traditional balance training on CAI. Therefore, WBV and balance training programs were designed and used for athletes with CAI in the current study.

       For basketball and volleyball players, ankle stability and motor control are crucial for ground impact during jumping and landing. The dominant leg is a commonly discussed factor in these types of actions by injured athletes because it plays a critical role in object manipulation and lead-out movements. However, the nondominant leg performs a stabilizing and supporting role in sports activities.

       Therefore, the dominant leg is highly susceptible to sports injuries such as ankle sprain and may suddenly become injured during jumping and landing on an unstable surface.    

        A systematic review revealed that female athletes sustained ankle sprains more often than male athletes. Sex-related differences in the epidemiology of ankle injuries were noted in sports injury protection.


NEED FOR THE STUDY:

The burden of these lower extremities injuries, especially ankle sprain, will always make the players or coaches experience physiological and psychological stress.

This is because the lack of awareness of the importance of balance training as their normal training routine will increase the risks of ankle sprain among the athletes and thus affect the performance.

Therefore, this research is intended to study the sports-specific balance training program for Pravara Institute of Medical Sciences (PIMS) basketball players in reducing their risk of ankle sprain.  

 

RESEARCH QUESTION

   What are the effects of whole body vibration and balance training in increasing ankle stability?

 

AIM AND OBJECTIVES

AIM:

To study the effects of Whole-Body Vibration Versus Balance Training on Athletes with Chronic Ankle Instability.

 OBJECTIVES: 

 To assess the Whole Body Vibration (WBV) effects on athletes.

 To assess the balance training effects on athletes.

 To compare WBV and balance training in athletes. 


Hypotheses:

Null Hypothesis (H0):

There will be no effects of whole-body vibration and balance training on athletes with chronic ankle instability.


Alternative Hypothesis (H1):  

There will be effects of whole-body vibration and balance training on athletes with chronic ankle instability.

MATERIAL AND METHODOLOGY:

 

Source of Data:  Pravara Institute of Medical Sciences, Loni

Study setting:  The study will be conducted at PMT Sports Ground, Loni BK

Study Duration: 2 years

Study Design: Randomized controlled  trial

Type of Data: Quantitative

Sample size: 45

Sampling Method: Randomized sampling

 

      Equipment to be used:

1.    BOSU ball

2.    Whole body vibrator

   Materials to be used:

1.    Informed consent forms

 


ELIGIBILITY CRITERIA:

Inclusion criteria:

Participants included will be:

Athletes should have a history of at least one ankle sprain.

Lateral ankle instability of any one leg with a severity score of 24 measured using theCumberland Ankle Instability Tool.

Both Genders.

Age group 19 to 25years.

 

Exclusion criteria:

Participants excluded will be: 

     Acute ankle sprain.

      Participants who are currently undergoing or have recently undergone specific interventions or treatments for ankle instability.

      Individuals who have experienced recent trauma or undergone surgery on the affected ankle.

      Individuals with significant cognitive impairments or conditions affecting decision-making abilities

      Those with systemic disorders or medical conditions that could impact joint stability or neuromuscular function (e.g., rheumatoid  

      arthritis, peripheral neuropathy). 

 

 OUTCOME MEASURES: Outcome measures used for this study will be:                              Dynamic balance - Star excursion balance test.                                                                                              Whole body balance - Stork balance stand test.


PROCEDURE:

The protocol is prepared, and Ethical Clearance will be obtained from the IEC at Dr. APJ Abdul Kalam College of Physiotherapy.

Participants will be selected on the basis of eligibility criteria.

Informed consent will be obtained from the participants, and demographic data will be recorded. 

Participants will be allocated into 3 groups - Group B[(Allocation to WBV  training group (n= 15)], Group A [Allocation to balance  training ( n=15)], and Group C [Allocation to control group (n=15)]

Prior assessment of the participants will be done using the Star Excursion Balance Test (SEBT) and the Stork Balance Stand Test for dynamic and whole body balance.

For 6 weeks, participants will be given the intervention three times a week.

Statistical analysis will be done, and results will be calculated.

Protocol:  

The participants were randomly divided into three groups:

Group A will complete a 6-week  balance training program using a BOSU ball.

Group B will complete a 6-week WBV training program.

Group C will continue the previous training program.

All participants will continue their normal daily activity and were instructed not to receive any treatments or therapy for CAI. Participants will be assessed before and after the study.

The participants underwent three assessments, including the Star Excursion Balance Test (SEBT).

The participants and researchers are not blinded to the study process.

Group A will use a balance ball (BOSU ball) for balance training.

Group B will perform the WBV exercises during the 6-week training programs and will use a Whole-Body Vibrator platform.

Group A will perform the exercises on the balance ball. Participants in both groups will be asked to maintain balance on either leg or the affected leg while having their eyes closed.

Group B participants will perform the exercises while standing on the vibration platform, which is operated at a frequency and amplitude of 5 Hz and 3 mm, respectively.

Both training programs will be conducted three times per week for 6 weeks and will consist of a 5-minute warm-up exercise, a 45-minute main exercise, and a 5-minute cool-down exercise.



REFERENCES

Sierra-Guzmán, R.; Jiménez, F.; Abián-Vicén, J. Predictors of chronic ankle instability: Analysis of peroneal reaction time, dynamic balance and isokinetic strength. Clin. Biomech. 2018, 54, 28–33.

Echarte, C.; Vaes, P.; Duquette, W. The dynamic postural control is impaired in patients with chronic ankle instability: Reliability and validity of the multiple hop test. Clin. J. Sport Med. 2009, 19, 107–114.

Delahunt, E.; Coughlan, G.F.; Caulfield, B.; Nightingale, E.J.; Lin, C.W.; Hiller, C.E. Inclusion criteria when investigating insufficiencies in chronic ankle instability. Med. Sci. Sports Exerc. 2010, 42, 2106–2121.

Schiffman, G.S.; Ross, L.A.; Hahne, A.J. The effectiveness of proprioceptive training in preventing ankle sprains in sporting populations: A systematic review and meta-analysis. J. Sci. Med. Sport. 2015, 18, 238–244.

De Ridder, R.; Willems, T.; Vanrenterghem, J.; Roosen, P. Influence of balance surface on ankle stabilizing muscle activity in subjects with chronic ankle instability. J. Rehabil. Med. 2015, 47, 632–638.


 
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