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CTRI Number  CTRI/2025/02/080397 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison between hopping exercises against ball exercise in volleyball players with ankle instability to improve balance and performance  
Scientific Title of Study   Comparison between Hop-Stabilization Versus Bosu Ball Training on Dynamic Balance and Performance in Volleyball Players with Chronic Ankle Instability  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nishant Kumar  
Designation  PG student  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  2-Floor,Sports-lab, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj
South
DELHI
110070
India 
Phone  8527133192  
Fax    
Email  nsnishantsingh03@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gaurav Kadyan PT 
Designation  Associate Professor  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  2-Floor,Sports-lab, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj

South
DELHI
110070
India 
Phone  9319133105  
Fax    
Email  gaurav.mpt@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gaurav Kadyan PT 
Designation  Associate Professor  
Affiliation  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences 
Address  2-Floor,Sports-lab, Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj

South
DELHI
110070
India 
Phone  9319133105  
Fax    
Email  gaurav.mpt@gmail.com  
 
Source of Monetary or Material Support  
Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Sector C, Vasant Kunj, New Delhi-110070 
 
Primary Sponsor  
Name  Dr Gaurav Kadyan PT 
Address  Indian Spinal Injuries Centre - Institute of Rehabilitation Sciences, Vasant Kunj, New Delhi 
Type of Sponsor  Other [self] 
 
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 Nishant Kumar PT  SU block volleyball coaching centre pitampura  SU-9, Block SU, Uttari Pitampura, Pitampura,Delhi, 110034 New Delhi DELHI
Central
DELHI 
8527133192

nsnishantsingh03@gmail.com  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Indian Spinal Injuries Center - Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M709||Unspecified soft tissue disorder related to use, overuse and pressure,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bosu Ball Training  GROUP B (Bosu-ball training) balancing exercises done on the unstable surface (18 sessions in 6 weeks) 
Intervention  Hop-Stabilization  GROUP A (Hop-stabilization training) Hopping based exercises on single and double leg progressively (18 sessions in 6 weeks) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  1. Any History of ankle sprain 12 months prior to the study enrollment.
2. Any feeling of giving way twice in last six months.
3. CAIT score less than 24.
4. Unstable anterior drawer test without sulcus.
5. Increased Hind foot varus mobility compared to other limb. 
 
ExclusionCriteria 
Details  1. Any history of knee and hip joint injury in last 3 months.
2. Any history of lower limb surgery. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Dynamic Balance (modified star-excursion balance test)
2. Functional Performance Tests (Single-limb hop test, Figure-of-8 hop test, Side hop test and Single-limb hurdle test)
 
At baseline and end of six weeks 
 
Secondary Outcome  
Outcome  TimePoints 
FAAM - Foot and Ankle Ability Measure
 
At baseline and end of six weeks 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   N/A 
Date of First Enrollment (India)   20/02/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The study aims to investigate the effectiveness of these two rehabilitation methods Hop-stabilization and Bosu ball training on dynamic balance and performance in volleyball players with chronic ankle instability (CAI) in improving dynamic balance and functional performance, using metrics like the Modified Star Excursion Balance Test (SEBT), Foot and Ankle Ability Measure (FAAM), and various functional performance tests (e.g., single-limb hopping test, figure-of-8 hop test). A null hypothesis posits no significant difference between the two methods, while the alternate hypothesis suggests a measurable difference.

The study adopts an experimental design with purposive sampling, enrolling 36 participants (18 per group) aged 18-30 years, who meet specific inclusion criteria, such as a CAIT score below 24 and a history of ankle instability. Exclusion criteria include recent injuries or surgeries affecting the lower extremities. Participants are randomized into two groups: one receiving hop-stabilization training and the other Bosu ball training, with assessments conducted at baseline and six weeks. The training is for 6weeks  (3 session per week)

Statistical analysis includes descriptive statistics, the Shapiro-Wilk test for normality, and tests like the Independent T-Test, Mann-Whitney U test, or Wilcoxon signed-rank test, depending on data distribution. Results will be analyzed using SPSS 21. The study’s findings will provide insights into optimizing rehabilitation techniques for athletes with chronic ankle instability, potentially guiding future interventions.

 
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