| CTRI Number |
CTRI/2024/12/078193 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| 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
|
Effect of Plank versus Reverse Plank Exercise on core muscle strength and balance in young adults with no symptoms. |
|
Scientific Title of Study
|
Effect of Plank versus Reverse Plank Exercise on core muscle strength, static balance and dynamic balance in asymptomatic young adults – Open labelled Randomized Controlled 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 |
Shubham Ashok Madane |
| Designation |
Student of Masters of Physiotherapy in Musculoskeletal Physiotherapy |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy.
Musculoskeletal Physiotherapy OPD number 4 and 5, KJ Somaiya medical College
Ayurvihar, Eastern Express Highway, Sion, Mumbai, MAHARASHTRA, 400022.
Mumbai MAHARASHTRA 400022 India |
| Phone |
8856075127 |
| Fax |
|
| Email |
s.madane@somaiya.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sneha Ganu |
| Designation |
Associate Professor |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy.
Musculoskeletal Physiotherapy OPD number 4 and 5, KJ Somaiya medical College,
Ayurvihar, Eastern Express Highway, Sion, Mumbai, MAHARASHTRA, 400022.
Mumbai MAHARASHTRA 400022 India |
| Phone |
9820790250 |
| Fax |
|
| Email |
s.ganu@somaiya.edu |
|
Details of Contact Person Public Query
|
| Name |
Shubham Madane |
| Designation |
Student of Masters of Physiotherapy in Musculoskeletal Physiotherapy |
| Affiliation |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy.
Musculoskeletal Physiotherapy OPD number 4 and 5, KJ Somaiya medical College
Ayurvihar, Eastern Express Highway, Sion, Mumbai, MAHARASHTRA, 400022.
Mumbai MAHARASHTRA 400022 India |
| Phone |
8856075127 |
| Fax |
|
| Email |
s.madane@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| KJ Somaiya College of Physiotherapy |
|
|
Primary Sponsor
|
| Name |
KJ Somaiya College of Physiotherapy |
| Address |
KJ Somaiya College of Physiotherapy.
Musculoskeletal Physiotherapy OPD number 4 and 5
Ayurvihar, Eastern Express Highway, Sion, Mumbai, MAHARASHTRA, 400022. |
| 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 Shubham Ashok Madane |
OPD number 4 and 5 |
KJ Somaiya College of Physiotherapy.
Musculoskeletal Physiotherapy,
Ayurvihar, Eastern Express Highway, Sion, Mumbai, MAHARASHTRA, 400022. Mumbai MAHARASHTRA |
8856075127
s.madane@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee KJ Somaiya College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Asymptomatic Healthy Individuals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
Asymptomatic subjects of all genders, belonging to the age group of 18 - 26 years, willing to participate. |
|
| ExclusionCriteria |
| Details |
Subjects with Musculoskeletal, Neurological and Cardiovascular Diseases,
2. Subjects with Injury in the upper and lower extremity in the last six months.
3. Subjects underwent any surgery of the upper and lower extremity and spine in the last six months.
4. Subjects involved in any Exercise program in the past 3 months like yoga and gym.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Core muscle strength by using Pressure Biofeedback Unit
2. Static balance by using Single Leg Stance Test
3. Dynamic balance by using the Y-Balance Test (YBT) |
Pre Intervention- Baseline assessment
Post 2 weeks of intervention
Post 4 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="130" Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
27/12/2024 |
| Date of Study Completion (India) |
04/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
Modification(s)
|
Approval is Obtained from the Institutional Ethics Committee. Participants will be screened according to the inclusion and exclusion criteria and a written informed consent will be obtained in the language best understood by them. Random Allocation will be done by the SNOSE (sequentially numbered, opaque, sealed envelopes) technique using computer-generated numbers into Group A and B. The dominant leg will be assessed using the ball kicking test which involves placing the ball in front of the participant and asking him to kick the ball. The leg used to kick the ball is considered as dominant leg by which the assessment will be done. The pre-test assessment of height and weight and history of injury and involvement of participant in any exercise programme will be done. These tests will be used as a screening test for recruiting participants along with other inclusion criteria. Pre-test assessment of Core muscle strength by using Pressure Biofeedback Unit, Static balance by using Single Leg Stance Test and Dynamic balance by using the Y-Balance Test (YBT) will be done and values will be noted. Group A will receive Plank exercise and Group B will receive Reverse plank exercise. Subjects in the plank exercise group will be explained about the proper method of Plank application technique. Subjects will be prone lying with hands by side of shoulder. Then the subject will be asked to lift the body up on the forearm and toes.. Same procedure will be repeated to make the subject familiar with the reverse plank position. Plank position will be achieved again and subjects will be encouraged to hold it for the predetermined period of time. Week-wise progression with respect to timing will be done.The progression in protocol will be as follow- WEEK 1- Plank Exercise 10 sec. hold*5 reps, with 30 sec. rest in between, 5 days a week; WEEK 2- Plank Exercise 20 sec. hold*5 reps, with 30 sec. rest in between, 5 days a week; WEEK 3- Plank Exercise 30 sec. hold*5 reps, with 30 sec. rest in between, 5 days a week; WEEK 4- Plank Exercise 40 sec. hold*5 reps, with 30 sec. rest in between, 5 days a week. Subjects in Reverse Plank exercise group will be explained about the proper method of Reverse Plank application technique. Subject will be in supine position with both shoulders internally
rotated and abducted, elbows flexed and wrist extended. Subject will
be then asked to extend shoulder and elbow so that the reverse plank
position will be achieved. Same procedure will be repeated to make
the subject familiar with the reverse plank position.
Then the Reverse Plank position will be achieved and held.
Progression with respect to timing and position will be done as Post test assessment will be done after 2 weeks and 4 weeks will be done and values will be noted. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined. Depending on the normality of data, statistical tests will be determined. Test that will be applied for intra-group analysis- Paired t-test Test that will be applied for inter-group analysis- Unpaired t-test If data does not follow normality Test that will be done for intra-group analysis Wilcoxon signed rank test. Test that will be done for inter-group analysis will be done Mann Whitney test. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant. Statistical Analysis will be done and results will be obtained |