| CTRI Number |
CTRI/2024/12/077715 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
02/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effect of Mobilization technique on Ankle Joint for Balance and Performance in Basketball Players with Long term Ankle Instability |
|
Scientific Title of Study
|
Effect of Mobilization with Movement of Distal Tibiofibular Joint on Dynamic Balance and Functional Performance in Basketball Players with Chronic Ankle Instability- An Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rutuja Chandrabhan Pofare |
| Designation |
Postgraduate |
| Affiliation |
PES Modern college of Physiotherapy, Pune |
| Address |
Progressive Education Society’s Modern College of Physiotherapy P.E.S.W.I.E Sports Complex, Modern College Road, Shivaji Nagar Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
7447229291 |
| Fax |
|
| Email |
rutuja99pofare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sucheta Golhar |
| Designation |
Professor and Principal |
| Affiliation |
PES Modern college of Physiotherapy, Pune |
| Address |
Progressive Education Society’s Modern College of Physiotherapy P.E.S.W.I.E Sports Complex, Modern College Road, Shivaji Nagar Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
9765726666 |
| Fax |
|
| Email |
sucheeta30.golhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sucheta Golhar |
| Designation |
Professor and Principal |
| Affiliation |
PES Modern college of Physiotherapy, Pune |
| Address |
Progressive Education Society’s Modern College of Physiotherapy P.E.S.W.I.E Sports Complex, Modern College Road, Shivaji Nagar Pune, Maharashtra
Pune
MAHARASHTRA
411005
India |
| Phone |
9765726666 |
| Fax |
|
| Email |
sucheeta30.golhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.E.S Modern College Of Physiotherapy, Modern College Road, Shivaji Nagar, Pune, Maharasthra -411005 |
|
|
Primary Sponsor
|
| Name |
P.E.S Modern College Of Physiotherapy |
| Address |
Progressive Education Society’s Modern College of Physiotherapy P.E.S.W.I.E Sports Complex, Modern College Road, Shivaji Nagar Pune, Maharashtra |
| 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 |
| Dr Rutuja Pofare |
Sports clubs |
Clubs around Pune
Pune
MAHARASHTRA |
7447229291
rutuja99pofare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| P.E.S Modern college of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M253||Other instability of joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mobilization with Movement of Distal Tibiofibular joint along with Regular Training. |
Subjects will be recruited after they fulfill the inclusion criteria. Pre-assessment or the baseline data of the recruited subjects will be taken by assessor and will include mSEBT, Figure of 8 Hop test and Lateral Hop test of all participates. Participates will be allocated into Experimental (Group A) and control groups (Group B) with odd and even method. Experimental Group will receive Mobilization with Movement of distal tibiofibular joint along with regular training. The participant’s inferior tibiofibular joint will be mobilized. The technique will be performed in supine lying with the tibia resting on the plinth and the foot unsupported off the plinth’s edge. The therapist stands at the foot end of the plinth and applies a sustained pain-free glide to the fibula in posterior, lateral and superior
direction. This glide is maintained while the participant performs active inversion or dorsiflexion to end of range. There should be no pain with the active movement. At the end of range, the practitioner will apply and sustain overpressure to the active movement for a few seconds (or the participant will do so after appropriate instruction). One treatment session will consist of three sets, with six to ten repetitions of the active movement in each set. Participants will receive between 9 sessions, over a period of 3 weeks.
Regular training consists of Warm up, agility training, strengthening, cold down exercises which will be done by both the groups regularly. After 3 weeks assessment of mSEBT, Figure of 8 Hop test, Lateral Hop test will be noted by assessor. Data obtained will be analyzed using paired t test within the group and unpaired t test between the group. |
| Comparator Agent |
Regular training |
Subjects will be recruited after they fulfill the inclusion criteria. Pre-assessment or the baseline data of the recruited subjects will be taken by assessor and will include mSEBT, Figure of 8 Hop test and Lateral Hop test of all participates. Participates will be allocated into Experimental (Group A) and control groups (Group B) with odd and even method.
Control group will receive regular training for 3 weeks.
Regular training consists of Warm up, agility training, strengthening, cold down exercises which will be done by both the groups regularly. After 3 weeks assessment of mSEBT, Figure of 8 Hop test, Lateral Hop test will be noted by assessor. Data obtained will be analyzed using paired t test within the group and unpaired t test between the group. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
A history of at least one significant ankle sprain with the Initial sprain must have occurred at least 12 months prior to enrolment. Sprain was associated with inflammatory symptoms. Created at least one interrupted day of desired physical
activity.
The most recent ankle injury must have occurred more than 3 months prior to enrolment. Participants should report at least two episodes of giving way in the 6 months prior to enrolment.
Unilateral Chronic Ankle Instability.
Cumberland Ankle Instability Tool (CAIT) less than 24.
Basketball Players with regular practice and participation in competitions. |
|
| ExclusionCriteria |
| Details |
A history of previous surgeries to the musculoskeletal structures (bones, joint structures, nerves) in either lower extremity.
A history of a fracture in either lower extremity requiring realignment.
Acute injury to musculoskeletal structures of other joints of the lower extremity in the previous 3 months that impacted joint integrity and function (sprains, fractures).
Contraindications of manual therapy (such as the presence of a tumor, fracture, severe vascular disease).
Receiving concurrent treatment- The most recent treatment for the ankle condition should have been received at least a week prior to enrolment.
Inability to read English. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Modified Start Excursion Balance test(mSEBT)
2.Figure of 8 Hop test
|
At Baseline (0 weeks) and after intervention after 3 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lateral Hop Test |
At Baseline (0 weeks) and after intervention after 3 weeks. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/12/2024 |
| Date of Study Completion (India) |
01/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/08/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Ankle sprains are most common injuries among active individuals,
approximately 74% of individuals who sustain a lateral ankle sprain have
residual symptoms, and they develop condition known as chronic ankle
instability (CAI), so understanding effective rehabilitation strategies is
crucial for their timely recovery and return to sports.
In basketball players due to repetitive jumping, cuttings, rapid stops, and
directional changes ankle sprain is very common, which further leads to
Chronic ankle instability (36–64%). It can affect the player’s confidence
and their ability to perform. A fast recovery allows them to regain
confidence in their ankle’s stability and functionality. Basketball players
may experience more frequent and potentially more severe ankle sprains
leading to chronic ankle instability due to the demands of their activities
than others.
MWM can help by improving joint alignment and reducing stress on
injured tissues. Assessing the impact of MWM can contribute to the
development of evidence-based interventions for managing different
factors in chronic ankle instability.
Ankle Instability can affect proprioception and balance, which are crucial
for the players performance. Studying the impact of MWM on balance can
provide insights into its potential role in improving proprioception and
reducing the risk of recurrent injuries.
Players with Chronic Ankle Instability may experience limitations,
affecting their ability to execute precise movements, make quick decisions,
and perform at their best. Investigating interventions like Mobilization
with Movement can help identify methods to enhance performance and
reduce the impact of Chronic Ankle Instability on basketball players.
All this can contribute to reducing the incidence of ankle injuries and
improving the overall health and longevity of basketball players’ careers.
Ankle instability, if not managed properly, can lead to chronic issues like
post traumatic osteoarthritis and increased injury risk in ankle joint. Assessing the impact of MWM on the recovery process may contribute to
preventing long-term complications associated with ankle instability.
Adding to the scientific literature on the effects of MWM in basketball
players with chronic ankle instability contributes to the overall body of
knowledge in sports medicine and physical therapy, potentially
influencing future research and clinical practices.
In conclusion, studying the effects of Mobilization with Movement of
Distal Tibiofibular joint on balance and functional performance in
basketball players with chronic ankle instability is valuable for both
clinical practice and the advancement of scientific knowledge in the field
of sports medicine. |