| CTRI Number |
CTRI/2025/04/084473 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of leg dominance on calf muscle activity during heel rise action in young adults |
|
Scientific Title of Study
|
Investigating influence of leg dominance in amplitude and spectral features of plantar flexors during heel rise action. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Geetika Hinduja |
| Designation |
Student |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University, Sector-87, Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9971473733 |
| Fax |
|
| Email |
geetikahinduja7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Chairperson and Professor |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University, Sector-87, Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9873430002 |
| Fax |
|
| Email |
drsanjeevgupta@gurugramunivesity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Geetika Hinduja |
| Designation |
Student |
| Affiliation |
Gurugram University |
| Address |
Department of Physiotherapy, Gurugram University, Sector-87, Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9971473733 |
| Fax |
|
| Email |
geetikahinduja7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Gurugram University |
|
|
Primary Sponsor
|
| Name |
Department of Physiotherapy |
| Address |
Gurugram University, Sector-87, Kankrola Village, Gurugram |
| Type of Sponsor |
Other [University] |
|
|
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 Geetika Hinduja |
Department of Physiotherapy, Gurugram University |
Gurugram University, Sector-87, Kankrola Village, Gurugram, Haryana
Gurgaon
HARYANA |
9971473733
geetikahinduja7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Department of Physiotherapy, Gurugram University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy state |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dominant and non dominant leg |
heel rise action performed by one leg followed by other leg after 7 days |
| Intervention |
Heel Rise Action |
heel rise action performed by participant unilaterally with dominant and non dominant leg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 to 25 yrs
Male/female
Non athlete college student
|
|
| ExclusionCriteria |
| Details |
Any Neuromusculoskeletal condition e.g. Fracture, deformity, nerve injury, multiple sclerosis, motor neuron disease etc.
Pre-existing injury / pain / Fatigue /DOMS in lower extremities
Any lower limb joints insufficiency
Any history of Ataxia / balance disorder or vertigo
Individuals under medication for neuromuscular pain
Any muscle tightness and contractures in lower limb
Any lower limb asymmetry
Abnormal foot arches and toe deformity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
SEMG Soleus peak amplitude
SEMG Gastrocnemius lateralis peak amplitude
SEMG Gastrocnemius medialis peak amplitude
SEMG Tibialis Anterior peak amplitude
SEMG Soleus spectral measure
SEMG Gastrocnemius lateralis spectral measure
SEMG Gastrocnemius medialis spectral measure
SEMG Tibialis Anterior spectral measure |
0th Day, 7th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SEMG Soleus onset time
SEMG Gastrocnemius lateralis onset time
SEMG Gastrocnemius medialis onset time
SEMG Tibialis Anterior onset time |
0th Day, 7th Day |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
Final Enrollment numbers achieved (Total)= "18"
Final Enrollment numbers achieved (India)="18" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/04/2025 |
| Date of Study Completion (India) |
29/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The study of leg dominance in relation to amplitude and spectral features of plantar flexors during the heel rise action is crucial for understanding muscle function and neuromuscular control between the dominant and non-dominant legs. This research can offer insights into muscle imbalances, which are important for injury prevention and rehabilitation, particularly in conditions like ankle sprains or Achilles tendon injuries. It also has implications for enhancing sports performance by identifying differences in muscle activation and improving training strategies. Additionally, this study could contribute to better monitoring tools for muscle function and personalized rehabilitation programs, benefiting athletes, older adults, and individuals in various occupational settings.
|