| CTRI Number |
CTRI/2026/04/107233 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| 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
|
A study comparing two exercise programs done for four weeks to improve balance and body awareness in young adults with ankle sprain aged between 18-30 years |
|
Scientific Title of Study
|
Effect of four weeks of proprioceptive neuromuscular facilitation versus progressive balance control strategies on balance and proprioception in ankle sprain aged 18-30 years - a randomized control trail |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Khushi Surana |
| Designation |
Post graduate student |
| Affiliation |
VSPMs college of Physiotherapy, Nagpur |
| Address |
Musculoskeletal department of VSPMs College of Physiotherapy, Nagpur
Nagpur
MAHARASHTRA
440016
India |
| Phone |
8530049079 |
| Fax |
|
| Email |
suranakhushi887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Mendhe |
| Designation |
Associate Professor |
| Affiliation |
VSPMs college of Physiotherapy, Nagpur |
| Address |
Musculoskeletal department of VSPMs College of Physiotherapy, Nagpur
Nagpur
MAHARASHTRA
440016
India |
| Phone |
9503173612 |
| Fax |
|
| Email |
kjanbandhu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Khushi Surana |
| Designation |
Post graduate student |
| Affiliation |
VSPMs college of Physiotherapy, Nagpur |
| Address |
Musculoskeletal department of VSPMs College of Physiotherapy, Nagpur
MAHARASHTRA
440016
India |
| Phone |
8530049079 |
| Fax |
|
| Email |
suranakhushi887@gmail.com |
|
|
Source of Monetary or Material Support
|
| Musculoskeletal department of VSPMs college of Physiotherapy Nagpur 440016 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Khushi Surana |
| Address |
Musculoskeletal department VSPMs college of Physiotherapy Nagpur Digdoh hills Hingana road Nagpur Maharashtra India 440016 |
| 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 Khushi Surana |
Lata Mangeshkar Hospital |
Department of Musculoskeletal Physiotherapy VSPMs college of physiotherapy Nagpur digdoh hills hingana road Nagpur Maharashtra
Nagpur
MAHARASHTRA |
8530049079
suranakhushi887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE VSPMs COLLEGE OF PHYSIOTHERAPY |
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 |
PROGRESSIVE BALANCE CONTROL STRATEGIES |
Progressive balance control exercise group includes balance exercises which have its modification done each week starting with Double Leg position grasping a medicine ball, Single leg balance on a soft surface, single leg hop to stabilisation level 1 exercises. Intervention for week two consists of single leg hop to stabilisation level 2 exercises, double leg balance on BOSU ball. BOSU single leg balance, Lateral hop stabilisation exercises. Single leg perturbation balance exercises with eyes open and visual perturbation is the protocol for the third week of rehabilitation. Single leg balance exercises with eyes closed, static standing 30 seconds for 7-10 times, single leg Balance with eyes closed perturbations is the protocol for the fourth week. The frequency of the exercises are 3 sets, 10 repetitions. The total duration of this intervention is four weeks |
| Intervention |
PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION |
This group will receive only proprioceptive neuromuscular facilitation exercises for four weeks 1) PNF rhythmic stabilization training - it consists of alternating ankle (plantar flexion, dorsiflexion, inversion and eversion ) isometric contraction against resistance for 10 sec with no motion intended. 3 sets of 10 repetitions are performed for the first week 2) Combination of Isotonic technique with ankle plantar flexion and dorsiflexion - resisted active concentric contraction for 5 sec, resisted eccentric contraction for 5 sec and resisted maintained during contraction for 5 sec 3 sets of 10 repetitions are performed for the second week. 3) Dynamic Reversals technique with active motion changing from one direction to the other without pause or relaxation. 3 sets of 10 repetitions are performed for third and fourth week of intervention
The total duration of this intervention is four weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed and referred cases of ankle sprain, non-athletic population aged between 18-30 years.
unilateral ankle sprain with Cumberland ankle instability tool score of less than 24.
|
|
| ExclusionCriteria |
| Details |
History of previous musculoskeletal structured surgeries to lower extremity.
History of fracture requiring re-alignment.
History of Grade 3 ankle sprain
Athletes and Elite Players
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Star Excursion Balance Test (SEBT) |
outcome measure should be assessed at baseline and at the end of four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Joint Position Sense (JPS)
Cumberland Ankle Instability Tool (CAIT)
Foot & Ankle Measure (FAAM) |
All outcome measures should be assessed at baseline & at the end of four weeks |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
20/04/2026 |
| 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="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 present study will be performed to see the effectiveness of Proprioceptive Neuromuscular Facilitation and Progressive Control Balance Strategies on ankle sprain of patients aged between 18-30 years. The study comprises of two groups in which one will be obtaining for PNF with conventional exercises and the other group Progressive Balance Control Strategies with conventional exercises. Outcome measures like balance and proprioception will be checked and compared pre and post study. |