| CTRI Number |
CTRI/2024/08/072108 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effects of posture correction vs. core training and deep foot muscle strengthening in students with altered foot pressure. A comparative study |
|
Scientific Title of Study
|
Effects of postural training vs. core activation and intrinsic foot muscle strengthening on plantar pressure asymmetry among asymptomatic college-going students. A comparative 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 |
Umme Salma Musaji |
| Designation |
MPT Scholar |
| Affiliation |
Parul institute of physiotherapy |
| Address |
3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
6378636146 |
| Fax |
|
| Email |
ummesalmafm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dharmang Vyas |
| Designation |
Assistant professor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8758958568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dharmang Vyas |
| Designation |
Assistant professor |
| Affiliation |
Parul institute of physiotherapy |
| Address |
3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8758958568 |
| Fax |
|
| Email |
dharmang.vyas@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| 3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, Pin code 391760, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Umme Salma Musaji |
| Address |
3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat |
| 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 Umme Salma Musaji PT |
Parul institute of physiotherapy, parul university |
3rd floor room no. 405, parul institute of physiotherapy, parul university, post limda, waghodia, gujarat
Vadodara
GUJARAT |
6378636146
ummesalmafm@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul university institutional ethics committee for human research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M629||Disorder of muscle, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Core activation and Intrinsic foot muscle strengthening |
Core activation - 4 weeks, 4 sessions per week
Bridges with leg lifts
Static abdominals (Prone planks)
Trunk rotation
Full vertical crunches
Intrinsic foot muscle strengthening - 4 weeks, 4 days per week
Toes spread out
Towel curl exercises
Great toe extension
Reverse tandem walk |
| Intervention |
Postural training |
Postural training - 4 weeks, 4 sessions per week
Deep breathing
Cat and camel stretch
Neck stretch
Pectoral stretch
Biceps strengthening
Triceps strengthening Quadriceps strengthening
Hamstring stretching |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Individuals willing to sign consent form
Individuals who understand Hindi, English or Gujarati
Individuals who have no restrictions on physical exertion |
|
| ExclusionCriteria |
| Details |
Cardiopulmonary & vascular conditions
Neuromuscular, neurological & musculoskeletal conditions
Individuals with a history of Upper limb, Lower limb or spinal surgeries within the last 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plantar pressure analysis EZRA software |
4 weeks
4 sessions per week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| stabiliometer analysis using OHM-3000 & EZRA software |
4 weeks
4 days per week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2024 |
| 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="0"
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
|
Studies have proven that plantar pressure is altered in young, healthy individuals with no symptoms. However, abnormal biomechanics and plantar pressure leads to abnormal biomechanics of the foot, resulting in increased risk of falls and injuries due to altered balance and proprioception. There are very few studies which focuses on restoring normal weight distribution and improving plantar pressure on the foot. Our study will determine the extent of altered foot pressure in normal healthy college going students and will also focus determine whether postural training v/s core activation and intrinsic foot muscle strengthening is effective in reducing abnormal plantar pressure and restoring the normal weight bearing in the foot |