| 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
|
|
|
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
|
|
|
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. |