| CTRI Number |
CTRI/2025/10/096112 [Registered on: 15/10/2025] Trial Registered Prospectively |
| Last Modified On: |
14/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find the best exercise method to improve ankle stability in young athletes. |
|
Scientific Title of Study
|
To compare the effectiveness of maitland mobilization versus mobilization with movement in young athletes 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 |
Pushpa Kumari |
| Designation |
PG Student |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
Amritsar
PUNJAB
143005
India |
| Phone |
08538940383 |
| Fax |
|
| Email |
pushpayadavyadav878@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
Amritsar
PUNJAB
143005
India |
| Phone |
09815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maman Paul |
| Designation |
Assistant Professor |
| Affiliation |
Guru Nanak Dev University |
| Address |
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
Guru Nanak Dev University, Physiotherapy Department,GT.Road, Amritsar, Punjab.
PUNJAB
143005
India |
| Phone |
09815459353 |
| Fax |
|
| Email |
mamanpaul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Dev University GT road Amritsar 143005 Punjab India |
|
|
Primary Sponsor
|
| Name |
Pushpa Kumari |
| Address |
Rasulpur Tilauta ,Pachrukhi Siwan 841233 Bihar |
| 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 Pushpa Kumari |
Health Center Of Guru Nanak Dev University |
Guru Nanak Dev University, Amritsar, punjab, INDIA.
Guru Nanak Dev University, Amritsar, punjab, INDIA.
Amritsar
PUNJAB |
08538940383
pushpayadavyadav878@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Of Guru Nanak Dev University AMRITSAR |
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 |
| Comparator Agent |
Conventional physiotherapy |
Participants in this group will receive Conventional Physiotherapy for a period of 4 weeks, with three sessions per week.
Each session will last for approximately 45 minutes and will include the following components:
Ankle strengthening exercises:
These include isometric, concentric, and eccentric exercises performed in both non-weight-bearing and weight-bearing positions to improve ankle muscle strength.
Stretching exercises:
Gentle stretching will be done for the ankle and calf muscles to improve flexibility and range of motion.
Proprioceptive and retraining exercises:
Exercises to improve balance, coordination, and control of ankle movement will be included.
Joint mobilization:
Gentle mobilization techniques will be applied to the talocrural and subtalar joints to maintain or improve joint mobility.
Each exercise will be performed for 5 repetitions, and the full session will last about 45 minutes. |
| Intervention |
Maitland Mobilization |
Group A (Maitland Mobilization):
Participants in this group will receive Maitland joint mobilization (Grade III and IV) for a period of 4 weeks, with three sessions per week.
Each session will last around 10 minutes and will include the following techniques:
Longitudinal traction of the subtalar joint:
The participant will lie on their back (supine position). The physiotherapist will apply gentle traction along the leg’s long axis to stretch the subtalar joint.
Forward and backward sliding:
Performed in the supine position. The physiotherapist will move the heel bone (calcaneus) forward and backward against the ankle bone (talus) using Maitland Grade III mobilization.
Internal and external sliding:
Performed with the participant lying face down or on the side. The physiotherapist will stabilize the ankle bone (talus) and apply medial or lateral gliding to the heel bone (calcaneus) to improve joint movement.
Each mobilization technique will be performed for 30 seconds per set, followed by a 1-minute rest, for a total of 3 sets. |
| Comparator Agent |
Mobilization With Movement |
Participants in this group will receive Mobilization With Movement (MWM) for 4 weeks, with three sessions per week.
Each session will last about 10 minutes and include the following techniques:
Ankle dorsiflexion MWM:
The participant will stand with one foot on the treatment table or step. The physiotherapist will apply a gentle forward glide to the lower leg (tibia) while the participant actively bends the ankle forward (dorsiflexion).
Ankle plantarflexion MWM:
Performed in a similar standing position. The physiotherapist applies a gentle backward glide to the tibia while the participant moves the ankle downward (plantarflexion).
Ankle inversion and eversion MWM:
The participant sits with the foot relaxed. The physiotherapist applies a sustained lateral or medial glide to the talus while the participant actively turns the ankle inward (inversion) or outward (eversion).
Each movement will be repeated 10 times per set, with a 1-minute rest between sets, for a total of 3 sets. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
A history of at least one significant ankle sprain, Reduced range of motion
Prior sprain must have occurred at least 12 months prior to study enrollment
A history of the previously injured ankle joint giving way and recurrent sprain or feeling of instability
Self reported ankle instability ,confirmed wit Cumberland ankle instability tool(less than or equal to 24) |
|
| ExclusionCriteria |
| Details |
1 A history of previous surgeries to the musculoskeletal structures
2 A history of a fracture in lower extremity in previous 3 months that impacted joint function
3 Have conditions for which radiological imaging is contraindicated (e.g., pregnancy)
4 Receiving concurrent treatment
5 The most recent treatment for the ankle condition should have been received at least a week prior to study enrolment
6 Bilateral chronic ankle instability
7 Any abnormal sensation or radiating pain in lower limb
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain may reduce with intervention in young athletes with chronic ankle instability |
Baseline, immediate post intervention ,4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Instability may reduce with intervention in young athletes with chronic ankle instability |
Baseline, immediate post intervention ,4 weeks |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
28/10/2025 |
| 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
|
This study aims to evaluate and compare the effects of Maitland mobilization, mobilization with movement, and conventional physiotherapy on pain, strength, range of motion, and balance in young athletes aged 18–28 years with chronic ankle instability. A total of 75 participants will be randomly divided into three groups and treated for four weeks, three sessions per week. Outcome measures include the Visual Analogue Scale (VAS), Star Excursion Balance Test (SEBT), Cumberland Ankle Instability Tool (CAIT),Balance Error Scoring System(BESS), Strength testing test, Single Leg Stance Test, and goniometer measurements. The expected outcome is a significant improvement in pain reduction, stability, and functional performance, helping determine the more effective manual therapy approach for managing chronic ankle instability. |