| CTRI Number |
CTRI/2024/06/069551 [Registered on: 26/06/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Balance and exercise training targeting specific muscle groups as an intervention for flat foot individuals to improve balance and height of foot arch. |
|
Scientific Title of Study
|
Impact of proprioceptive Drills regimen for gluteus Medius and intrinsic foot Muscles on balance and arch Height in individuals with Flat foot: A Quasi Experimental study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jennifer Dsouza |
| Designation |
Post graduate Student |
| Affiliation |
Nitte Institute Of Physiotherapy, Nitte Deemed to be University |
| Address |
Nitte Institute Of Physiotherapy,Nitte Deemed to be University,Department of Physiotherapy,Dept no 20,Justice K S.Hegde hospital,Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
6360356113 |
| Fax |
|
| Email |
jenniferdsouza461@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Professor |
| Affiliation |
Nitte Institute Of Physiotherapy, Nitte Deemed to be University |
| Address |
Nitte Institute Of Physiotherapy,Nitte Deemed to be University,Department of Physiotherapy,Dept no 20,Justice K S.Hegde hospital,Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanesh Kumar K U |
| Designation |
Professor |
| Affiliation |
Nitte Institute Of Physiotherapy, Nitte Deemed to be University |
| Address |
Nitte Institute Of Physiotherapy,Nitte Deemed to be University,Department of Physiotherapy,Dept no 20,Justice K S.Hegde hospital,Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019431417 |
| Fax |
|
| Email |
principal.nipt@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Institute of Physiotherapy, Nitte Deemed to be University, Department of Physiotherapy,Second base division,Department no 20,Justice K S.Hegde hospital,Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka,India 575018 |
|
|
Primary Sponsor
|
| Name |
Nitte Deemed to be University |
| Address |
Nitte Institute Of Physiotherapy,Nitte Deemed to be University,Second base division,Department no.20 Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka, India 575018
|
| Type of Sponsor |
Research institution |
|
|
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 Dhanesh Kumar K U |
Nitte Institute of Physiotherapy |
Nitte Institute Of Physiotherapy,Nitte Deemed to be University,Department of Physiotherapy,Second base division, Department no 20,Nithyananda nagar,Derlakatte,Mangaluru,Dakshina Kannada,Karnataka,India 575018
Dakshina Kannada
KARNATAKA |
9019431417
principal.nipt@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Nitte Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Young adults having flat foot deformity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Proprioceptive Drills Regimen |
Warm up exercises will be given for a period of 5 mins, followed by the regimen.
This proprioceptive intervention includes two components given for 40 mins to group B
1.Single leg stance balance drills for a period of 22 minutes including rest times consisting of balance exercises to be performed for 1 minute each on each leg with eyes open and eyes closed on stable surface and then bosu board.
On stable surface
- Single leg stance with toe raises
a.Right leg :
Eyes open 1min
Eyes closed 1min
b.Left leg :
Eyes open 1min
Eyes closed 1min
REST TIME 1min
- Single leg stance with heel raises
a.Right leg :
Eyes open 1min
Eyes closed 1min
b.Left leg :
Eyes open 1min
Eyes closed 1min
REST TIME 2mins
On bosu board
- Single leg stance with toe raises
a.Right leg :
Eyes open 1min
Eyes closed 1min
b.Left leg :
Eyes open 1min
Eyes closed 1min
REST TIME 1min
- Single leg stance with heel raises
a.Right leg :
Eyes open 1min
Eyes closed 1min
b.Left leg :
Eyes open 1min
Eyes closed 1min
REST TIME 2mins
2. Tip toe lateral walks performed for 5 repetition for 5 minutes.
REST TIME 3mins
3. Lateral walk overs on bosu board for 5 mins.
This whole intervention will be performed for 5 days a week for a total period of 4 weeks.
On stable surface
- Single leg stance with toe raises
a.Right leg : Eyes open
Eyes closed
b.Left leg : Eyes open
Eyes closed
REST TIME
- Single leg stance with heel raises
a.Right leg : Eyes open
Eyes closed
b.Left leg : Eyes open
Eyes closed
REST TIME
On bosu board
- Single leg stance with toe raises
a.Right leg : Eyes open
Eyes closed
b.Left leg : Eyes open
Eyes closed
REST TIME
- Single leg stance with heel raises
a.Right leg : Eyes open
Eyes closed
b.Left leg : Eyes open
Eyes closed
The intervention would be given for 5 days a week for a total period of 4 weeks with a frequency of once a day. |
| Comparator Agent |
Short foot exercises |
Warm up exercise for a period of 5 mins.
Short foot exercises given is the conventional treatment for flat foot such as toe curls, great toe extension , toe spread , ball roll and stretching for the group A for a period of 35 minutes.
2 sets performed 10 reps for each exercise performed with intermittent breaks.
These exercises would be given for an equal time period of 5 days a week for a total period of 4 weeks with a frequency of once a day. |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Students with asymptomatic flexible flat foot in the age ranging from 17-25 years
2.Students of both genders. |
|
| ExclusionCriteria |
| Details |
1.Students not willing to participate
2. Rigid flat foot
3.Pain in lower extremities
4.Foot deformities like Hallux valgus , hallux rigidus
5.Students with ankle instability, previous lower limb injuries
6.Underwent prior ankle or foot surgery
7.Overweight or obese individuals
8.Students having balance issues and any vascular conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Foot Posture Index
To determine whether the foot is high arched, normal or flat foot.
|
1.At baseline (1st day)
2.End of the intervention at 4 weeks
The intervention period is 4 weeks.
There is no follow up period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Unipedal stance test
To evaluate the static balance |
1.At baseline(1st day)
2.End of the intervention at 4 weeks |
Y balance test
To evaluate the dynamic balance |
1.At baseline(1st day)
2.End of the intervention at 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| 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)
|
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
|
Pes planus or flatfoot is a common foot condition that affects 2% to 23% of adult population.Foot alignment is influenced by the strength and function of the lower extremities such as the gluteus muscles that assist in hip stabilization and intrinsic foot muscle (IFM) such as abductor hallucis, flexor digitorum brevis, and interosseous muscles that contribute to stabilizing the foot arch during propulsion. Flat foot leads to greater weight distribution on the medial aspect of the foot, causing alteration in foot biomechanics thus impacting balance and stability leading to poor balance scores during quiet standing and consequently increased peak plantar pressure on the MLA. Proprioceptive drills regimen given to group B which includes balance exercise and lateral walks specifically targetting gluteus medius and intrinsic foot muscles could have a positive impact on the arch height and balance.Thus incorporting balance exercise on stable surface and bosu board along with lateral walks is the main intervention of the study compared to the conventional treatment of short foot exercises given to group A. |