| CTRI Number |
CTRI/2024/02/062182 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
18/06/2024 |
| 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
|
Effectiveness of combined training in badminton players with ankle sprain |
|
Scientific Title of Study
|
Effectiveness of combined balance and plyometric training in badminton players with lateral ankle sprain |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samistha Baidh |
| Designation |
PG student |
| Affiliation |
Amity Institute of Health Allied Sciences Amity University Noida |
| Address |
Room number 03, Lower ground floor, F-1 Block, Department- Amity Institute of Health Allied Sciences Amity University Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
08217656698 |
| Fax |
|
| Email |
samisthabaidh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute of Health Allied Sciences Amity University Noida |
| Address |
Room number 107A, First Floor, F-1 Block, Department- Amity Institute of Health Allied Sciences, Amity University, Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute of Health Allied Sciences Amity University Noida |
| Address |
Room number 107 A, First Floor, F-1 Block, Department- Amity Institute of Health Allied Sciences Amity University Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity Institute of Health Allied Sciences Amity University Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Samistha Baidh |
| Address |
Lower ground floor, Room Number 03, F-1 Block, Amity Institute of Health Allied Sciences, Amity University Student, Noida, Uttar Pradesh |
| Type of Sponsor |
Research institution |
|
|
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 Samistha baidh |
PRO Mobility Sports Physiotherapy |
Physiotherapy room, Physiotherapy department, Sarfabad, Sector 73, Noida, Uttar Pradesh, 201307
Gautam Buddha Nagar
UTTAR PRADESH |
8217656698
samisthabaidh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Instituitional NTCC Committee Amity Institute of Health Allied Sciences AMITY UNIVERSITY UTTAR PRADESH |
Approved |
| PRO Mobility Sports Physiotherapy |
No Objection Certificate |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined balance and plyometric training |
Exercises will be performed 3 days every week for 6 weeks. Total time duration for each session will be 55 mins.
Warm up will include Jogging, Jumping Jack, side step jack which will take 10 minutes.
Cool down will include Stretching of calf, hamstrings, quadriceps and hip flexor which will take 5 mins.
Experimental group will perform both balance and plyometric exercises.
Balance exercises will be performed for 1 minute with 1 minute rest between each exercise.
Plyometric exercises will be done for 2 sets containing 15 repetitions in each set with 1 minute rest between each set.
Week One
Balance exercises
Done with eyes open on the floor
Unilateral standing; Unilateral standing and swinging the lifted leg; Unilateral standing and kicking the lifted leg
Week Two
Balance exercises
Done with eyes closed on the floor
Unilateral standing; Unilateral standing and swinging the lifted leg; Unilateral standing and kicking the lifted leg
Week one and two
Plyometric exercises
Done with eyes open on the floor
Jumping on ankle; Ski jumps; Jumping squat; Side to side leaps
Week three
Balance Exercises
Done with eyes open on the board
Unilateral standing; Unilateral standing and swinging the lifted leg; Bilateral standing whilst board tilts
Week four
Balance Exercises
Done with eyes closed on the board
Unilateral standing
Done with eyes open on the board
Unilateral standing and swinging the lifted leg; Unilateral leg standing whilst board tilts
Week three & four
Plyometric Exercises
Done with eyes open on the floor
Heisman; Switch foot in low squat position; Ankle hops- front to back; Ankle hops- side to side
Week five & six
Balance exercises
Done with eyes closed on the board
Unilateral standing
Done with eyes open on the board
Unilateral standing whilst moving the board; Unilateral standing whilst kicking the raised leg
Week five & six
Plyometric exercises
Done with eyes open on the floor
Heisman; In and out in squat position; Unilateral ankle jumps; Unilateral side to side ankle hops
|
| Comparator Agent |
Regular training |
They will perform warm up for 10 minutes containing jogging, jumping jacks, side stap jack followed by regular training of 1 hour and cool down of 5 minutes containing stretching of calf, hamstrings, quadriceps and hip flexors. The total duration of control group will be 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 35 years; Grade 1 and 2 ankle sprain 6 weeks before; Both male and female; recreational badminton players; no pain on walking and jumping vertically; no swelling or tenderness; met the prerequisites for plyometric training |
|
| ExclusionCriteria |
| Details |
1. Recurrent ankle sprain
2. Ankle fracture
3. Grade III Ankle Sprain
4. Any other lower extremity injury or surgery
5. Part of another research
6. History of neurological disease, vestibular or visual disturbance or any other pathology
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Static Balance
Dynamic Balance- modified Star Excursion Balance Test
Functional Performance- Single Hop test
Athlete Life Quality- Athlete Life Quality Scale |
Measured Pre and Post intervention of 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Athlete Life Quality- Athlete Life Quality Scale |
Measured Pre and Post intervention of 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
06/02/2024 |
| Date of Study Completion (India) |
30/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 purpose of this study is to examine the effectiveness of combined balance and plyometric training in badminton players with lateral ankle sprain. This is an experimental study which will recruit 40 patients with lateral ankle sprain wherein the individuals will be assessed and those who meet inclusion criteria will be taken. Outcome measures will be recorded before the intervention of 6 weeks following which intervention will be performed by the patients. Outcome measures will be measured again after the intervention and the data will be analyzed. |