| CTRI Number |
CTRI/2021/01/030215 [Registered on: 04/01/2021] Trial Registered Prospectively |
| Last Modified On: |
|
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of meditation technique (Mindfulness Based Stress Reduction) on Fear of re-injury in athletes having ankle injury more than three months |
|
Scientific Title of Study
|
Effects of Mindfulness Based Stress Reduction on kinesiophobia in athletes having chronic ankle instability: A Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Tiwari |
| Designation |
Post Graduate |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Department of Sports Physiotherapy,1st floor,Sancheti Healthcare Academy ,11/12 Thube park shivajinagar, Pune 411005 Sancheti Institute of Orthopaedics and Rehabilitation
Maharashtra
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9920681318 |
| Fax |
|
| Email |
nidhit03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand Gangwal |
| Designation |
Associate Professor, Department of Sport Physiotherapy |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Department of Sports Physiotherapy,1st floor,Sancheti Healthcare Academy ,11/12 Thube park shivajinagar, Pune 411005
Maharashtra
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Gangwal |
| Designation |
Associate Professor , Department of Sports Physio |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Department of Sports Physiotherapy,1st floor,Sancheti Healthcare Academy ,11/12 Thube park shivajinagar, Pune 411005
Maharashtra
411005
India
Pune
MAHARASHTRA
411005
India |
| Phone |
9960323333 |
| Fax |
|
| Email |
anandgangwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute College of Physiotherapy |
| Address |
11,12, Thube Park ,Shivajinagar , Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Nidhi Tiwari |
Sancheti Hospital for Orthopaedics and Rehabilitation |
16,Floor 1 Department of Musculoskeletal Physiotherapy Shivajinagar Pune Maharashtra
Pune
MAHARASHTRA |
9920681318
nidhit03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M708||Other soft tissue disorders related to use, overuse and pressure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mindfulness Meditation,
Standard Physiotherapy - Strengthening and Balance and proprioception |
30 minutes of Mindfulness Meditation
Strengthening with TheraBand for ankle evertors,invertors,plantarflexors and dorsiflexors
Balance and Proprioception :
Backforth,side to side and standing on injured leg (30 secs each ) ,6 intervals with 10 seconds rest |
| Comparator Agent |
Standard Physiotherapy - Strengthening and Balance and proprioception |
Strengthening with TheraBand for ankle evertors
,invertors,plantarflexors and dorsiflexors Balance and Proprioception : Backforth,side to side and standing on injured leg (30 secs each ) ,6 intervals with 10 seconds rest |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Ankle Injury for more than 3 months
Higher Cumberland Ankle Instability tool Score |
|
| ExclusionCriteria |
| Details |
Any recent history of Fracture , Systemic Disease
Recent history of acute ankle sprain |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tampa Scale of Kinesiophobia-11 (TSK-11),
Mindfulness Awareness Attention Scale (MAAS)
Figure of 8 hop test |
Baseline
after 2nd week
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Figure of 8 hop test |
Baseline
after 2nd week
4th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
06/01/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a Randomized Control Trial which aims to study the effects of mindfulness based stress reduction incorporating Standard physiotherapy in athletes those who have fear of reinjury post 3 months of ankle injury . Kinesiophobia will be measured using Tampa Scale of Kinesiophobia -11, Mindfulness Attention Awareness Scale (MAAS) and figure of 8 hop test. Two groups of 20 subjects each will be randomly allocated, both groups will recieve Standard Physiotherapy which includes TheraBand Strenghtening exercise for ankle Invertors ,Dorsiflexors , Plantarflexors , Evertors and Balance and proprioception exercise using wobble board (Backforth, side to side and balancing on injured leg ) for 30 seconds for 6 intervals with 10 seconds rest and one group with recieve 30 minutes of Mindfulness Meditation in addition to standard Physiotherapy and Outcomes will be measured on Day 1 before treatment , 2nd week and 4th week post treatment and compared for the difference |