| CTRI Number |
CTRI/2025/07/092112 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
31/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Structured Exercise Program on pain in Ankle Sprain |
|
Scientific Title of Study
|
Structured Exercise Program on Pain intensity, sensitivity, and quality in Young Athletes with Acute Lateral Ankle Sprain: A Randomized Controlled Trial (SEPALAS Trial) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suraiya Yesmin Sharna |
Dr. M R Khan Medical Centre |
Room No: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
|
01786395080
sharnajust1019@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of the Department of Physiotherapy and Rehabilitation at Jashore University of Science and Technology |
Approved |
|
|
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 |
| Comparator Agent |
Control group (UC) |
Participants in the control group will initially follow the PRICE protocol (Protection, Rest, Ice, Compression, Elevation) during the first 72 hours post-recruitment to manage acute pain and inflammation. Following this, they will receive general recovery guidelines over the 6-week period, including home-based self-care instructions, such as basic ankle ROM exercises (e.g., ankle pumps, circles), gentle stretching, and gradual return to daily and sports activities as symptoms allow. No supervised physiotherapy or structured exercise program will be provided. Participants may also take over-the-counter analgesics (e.g., paracetamol or NSAIDs) as needed for intolerable pain or comfort. This approach reflects the standard conservative care typically provided for acute lateral ankle sprains in routine clinical settings. |
| Intervention |
Experimental group (SEP) |
Participants will initially follow the PRICE protocol (Protection, Rest, Ice, Compression, Elevation) for the first 72 hours post-recruitment to reduce pain and inflammation. After this phase, a structured exercise program will be implemented over 18 sessions, distributed as follows:
Stage I (Sessions 1–6): Focus on pain reduction, ROM, and early activation. Exercises will include calf muscle stretching (30-second hold, 5 reps), ankle and subtalar joint ROM in all directions (10 reps × 3 sets), and resistance band exercises (10 reps × 3 sets per direction). Toe curls and towel scrunches (10 reps × 2 sets) will also be added to engage intrinsic foot muscles.
Stage II (Sessions 7–12): Emphasis on muscle strengthening and proprioceptive control. Continuation of earlier exercises with added bilateral heel-to-toe raises, squats, and lunges (10 reps × 3 sets). Balance training on stable surfaces, gait retraining (e.g., heel-to-toe walking, toe-to-toe walking, tandem walking), and step-ups (as tolerated) will be introduced.
Stage III (Sessions 13–18): Functional and sport-specific training phase. Includes unilateral heel raises, single-leg squats, and advanced resistance band work (10 reps × 3 sets each). Dynamic balance training (wobble board, BOSU), Star Excursion Balance Test (SEBT) drills, plyometric drills (e.g., lateral hopping, bounding), and agility training (shuttle runs, figure-8s) will be performed.
Pain will be monitored each session, and progression will depend on tolerance. Participants will attend three sessions per week, all of which will be supervised by a trained physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be included if – (1) male or female athletes aged between 18 and 30 years; (2) diagnosis of Grade I or II lateral ankle sprain confirmed by ultrasound imaging; (3) sustained the injury within 0 to 72 hours prior to recruitment; (4) provide written informed consent and agree to participate in the full assessment and intervention protocol. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if – (1) Fracture or dislocation of the foot or ankle, or other soft tissue injuries beyond lateral ankle sprain; (2) History of ankle surgery, or ankle trauma within the past 3 months. (3) Chronic ankle instability or lower limb peripheral nerve injuries; (4) Recent trauma, and pregnancy history; (5) Any medical, legal, or physical condition that hinders safe participation in the exercise program. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain intensity (measure using the NPRS), pain sensitivity (measure using the algometer), and pain quality (assess using the McGill Pain Questionnaire). |
At baseline, 3 weeks, 6 weeks and 18 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Muscle strength (measure using the dynamometer), Physical function (measure using the Foot and Ankle Ability Measure – FAAM), and Agility (measure using the Agility T-test). |
At baseline, 3 weeks, 6 weeks and 18 weeks |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="0"
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)
|
16/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/08/2025 |
| 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 Yet Recruiting |
| 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 SEPALAS Trial will be
a randomized controlled study designed to evaluate the effectiveness of a
Structured Exercise Program (SEP) compared to Usual Care (UC) in young athletes
(aged 18–30) with Grade I or II acute lateral ankle sprains confirmed by
ultrasound. Eighty participants will be randomly assigned to either the SEP
group, which will receive a progressive, physiotherapist-supervised exercise
program over 18 sessions following an initial 72-hour PRICE protocol, or the UC
group, which will follow standard self-care guidance with optional analgesics.
The SEP will progress through three stages: pain and ROM restoration, muscle
strengthening with proprioception, and sport-specific functional training.
Primary outcomes will include pain intensity (NPRS), pain sensitivity
(algometer), and pain quality (McGill Pain Questionnaire). Secondary outcomes
will assess muscle strength (dynamometer), physical function (FAAM), and
agility (Agility T-test). All outcomes will be measured at baseline, 3 weeks, 6
weeks, and 18 weeks to determine the program’s clinical effectiveness in
promoting recovery and functional return. |