| CTRI Number |
CTRI/2024/07/071484 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening
Other (Specify) [ohysiotherapy interventions for treatment] |
| Study Design |
Other |
|
Public Title of Study
|
To study and compare the effect of Fascial Distortion Model and KCAT with dynamic balance training on balance and reaction time in individuals with chronic ankle instability |
|
Scientific Title of Study
|
Effect of Fascial Distortion Model and KCAT on balance and reaction time in individuals with chronic ankle instability- A randomized clinical 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 |
Lizanne Alina Vaz |
| Designation |
PG student |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9637408777 |
| Fax |
|
| Email |
vazlizanne@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Metgud |
| Designation |
Professor |
| Affiliation |
KLE Institute of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgaum
Belgaum
KARNATAKA
590010
India |
| Phone |
9880088400 |
| Fax |
|
| Email |
santoshmetgud@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital And Research Centre, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
KAHER Institute Of Physiotherapy |
| Address |
KAHER Institute Of Physiotherapy, Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgaum, Karnataka, India |
| 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 Lizanne Alina Vaz |
KAHER Institute of Physiotherapy |
KAHER Institute of Physiotherapy, OPD no. 13, Orthopaedic Manual Therapy Department, JNMC Campus, Nehru Nagar, Belgaum, Karnataka
Belgaum
KARNATAKA |
9637408777
vazlizanne@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research And Ethical Committee KLEU Institute of Physiotherapy Belagavi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fascial Distortion Model and balance training |
This group will receive Fascial Distortion Model and balance training. The four distortions that will be incoorperated in Fascial Distortion Model are Trigger band (TB),Continuum distortion (CD),Folding distortions (rFD and uFD)and Cylinder distortion (cyD). A dynamic balance-training program developed by McKeon et al for those with CAI will also be given to the participants. The intervention will be given for 12 sessions over a period of 3 weeks (4 sessions/ week, 30min/ session).
|
| Intervention |
KCAT and balance training |
This group will receive KCAT and balance training. Participants will receive KCAT technique and a dynamic balance-training program developed by McKeon et al for those with CAI will also be given to the participants. The intervention will be given for 12 sessions over a period of 3 weeks (4 sessions/ week, 30min/ session).
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
32.00 Year(s) |
| Gender |
Both |
| Details |
Males and Females between 15 to 32 years, scoring between 11 to 24 on the Cumberland Ankle Instability Tool (CAIT), with a history of at least one ankle sprain (lateral or medial ankle sprain) and experiencing ankle instability or giving away of the ankle in the last year. |
|
| ExclusionCriteria |
| Details |
Pain and swelling in the ankle, participated in formal rehabilitation within the past 3 months, with a history of lower limb surgery or fracture of involved limb, any neuromotor or sensorimotor dysfunction on the lower limb and any congenital ankle deformities. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cumberland ankle instability tool (CAIT)
Blazepod
Tetrax interactive balance system
star excursion balance test (SEBT) |
Cumberland ankle instability tool (CAIT) will be used to screen the individuals prior the intervention.
Blazepod, Tetrax interactive balance system and star excursion balance test (SEBT) will be used to assess the participants at baseline and post 12 sessions of intervention, that is, after 3 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/09/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/03/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
Chronic Ankle Instability is mainly due to a sprain in the ligaments (medial and lateral) in the ankle. This study will be conducted to compare the effect of Facial Distortion Model (FDM) and KCAT in individuals with Chronic ankle instability. Individuals will be screened using the Cumberland Ankle Instability tool (CAIT) and 30 participants will be included in the study based on the inclusion and exclusion criteria of the study. They will be randomly divided into two groups, one group receiving Facial Distortion model along with balance training and the other group receiving KCAT along with balance training. 12 sessions will be given for a period of 3 weeks ( 4 sessions/ week and 30min/ session). Balance and reaction time will be assessed prior and post the intervention using the Tetrax Interactive Balance System, Star excursion Balance Test (SEBT) and blazepods. The results will be statistically analyzed and a conclusion will be drawn. |