| CTRI Number |
CTRI/2024/03/064306 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| 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
|
comparing a rehabilitation protocol with balance training protocol to see the difference in balance and gait with patients with chronic ankle instability |
|
Scientific Title of Study
|
Comparison of Foot Intensive Rehabilitation and Balance Training with Rhythmic Stabilization on Dynamic Balance and Gait in Individual 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 |
Dr Nikita Gangwani |
| Designation |
PG student |
| Affiliation |
Ravi Nair Physiotherapy College, Sawangi(Meghe), Wardha |
| Address |
Department of Musculoskeletal, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
7000284654 |
| Fax |
|
| Email |
nikitagangwani29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Sawangi(Meghe) Wardha |
| Address |
Department of Musculoskeletal Physiotherapist.
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Patil |
| Designation |
Associate Professor |
| Affiliation |
Ravi Nair Physiotherapy College, Sawangi(Meghe) Wardha |
| Address |
Department of Musculoskeletal Physiotherapist.
Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Sawangi(Meghe) Wardha.
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975453662 |
| Fax |
|
| Email |
dvjphysio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ravi Nair College Of Physiotherapy, Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute Of Higher Education And Research(Deemed To Be University), Sawangi(Meghe) Wardha, Maharshtra, India |
|
|
Primary Sponsor
|
| Name |
Ravi Nair College Of Physiotherapy |
| Address |
Department of Musculoskeletal, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research(DU) Sawangi(Meghe) Wardha |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nikita Gangwani |
Acharya Vinoba Bhave Rural Hospital, Musculoskeletal OPD |
Department of Musculoskeletal,Ravi Nair College Of Physiotherapy, Datta Meghe Institute Of Higher Education And Research(Deemed To Be University), Sawangi(Meghe) Wardha, Maharshtra, India
Wardha
MAHARASHTRA |
7000284654
nikitagangwani29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DMIHER(DU) |
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 |
| Comparator Agent |
Balance Training with Rhythmic Stabilization |
The warm-up comprises ankle stretches, joint mobilization, and 30-second holds for standing ankle dorsiflexion/plantar flexion. The main regimen includes core, hip, and ankle strengthening exercises, progressing from basic to advanced dynamic balance exercises. The cool-down involves sets of 30-second holds for standing wall pushing and stretching, aiming to enhance strength, balance, stability, and proprioception.This intervention protocol will be given for 3 weeks. |
| Intervention |
Foot Intensive Rehabilitation |
The rehabilitation program focuses on ankle function improvement through joint mobilization, stretching, and balance exercises. It targets ankle and hip strength with various exercises like squats and ankle isotonics. Balance is improved with single limb and hop-to-stabilization exercises. Sensorimotor function is managed through massage and foot muscle activation techniques.This intervention Protocol will be given to patients for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Subjects having limited ankle range of motion
History of recurrent fall
Patients complaining of giving away sensation in ankle joint
Participants must be able to walk community distances without an assistive device
Cumberland Ankle Instability Tool CAIT score less than 24
|
|
| ExclusionCriteria |
| Details |
Ankle surgery in the last 3 months
Acute ankle sprain
Chronic Ankle Instability with a history of neurological disease fractures and other musculoskeletal injuries in the lower limbs
Any knee hip ankle deformity
Participants with bilateral ankle dysfunction.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Star excursion balance test, The XSens, Foot and Ankle Outcome Score, Cumberland Ankle Instability Tool |
outcomes will be assessed at baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proprioceptive sense, Range of Motion |
outcomes will be assessed at baseline and after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Aim of this study is to assess the effect of Foot Intensive
Rehabilitation and balance training combined with Rhythmic Stabilization in
improving gait parameter occurring with chronic ankle instability assessed with
Star excursion balance test, XSENS, FAOS and CAIT and to compare the effect of
Foot Intensive Rehabilitation and balance training in combination with rhythmic
stabilization in balance and gait measured with assessed with Star excursion
balance test, XSENS, FAOS and CAIT. |