| CTRI Number |
CTRI/2025/04/084268 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Investigating leg muscles activity during heel rise action |
|
Scientific Title of Study
|
Electromyographic analysis of leg muscles activation during heel rise activity in young adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARUL |
| Designation |
MPT Student |
| Affiliation |
Gurugram university |
| Address |
Department of Physiotherapy,
Gurugram University, Sector-87,
Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9625636409 |
| Fax |
|
| Email |
parulyadavkaliawas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjeev Gupta |
| Designation |
Chairperson and Professor, Physiotherapy, Gurugram University |
| Affiliation |
Gurugram university |
| Address |
Department of Physiotherapy,
Gurugram University, Sector-87,
Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9873430002 |
| Fax |
|
| Email |
drsanjeevgupta@gurugramuniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
PARUL |
| Designation |
MPT Student |
| Affiliation |
Gurugram university |
| Address |
Department of Physiotherapy,
Gurugram University, Sector-87,
Kankrola Village, Gurugram
Gurgaon
HARYANA
122505
India |
| Phone |
9625636409 |
| Fax |
|
| Email |
parulyadavkaliawas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy ,Gurugram university , kankrola village sector 87 , Gurugram ,Haryana 122505 |
|
|
Primary Sponsor
|
| Name |
Department of physiotherapy |
| Address |
Gurugram University, ,Sector-87 ,Kankrola village, Gurugram , Haryana 122505 |
| 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 Parul |
Gurugram University |
Department of Physiotherapy, Gurugram University, Sector 87, kankrola village
Gurgaon
HARYANA |
9625636409
parulyadavkaliawas@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 |
Young Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Heel rise action in knee extension |
Participant stands on limb to be tested with knee extended
The participant is likely to need external support; thus, fingers can be placed on the table, above shoulder height. Alternatively, no more than two fingers should be used on a table. Participant should not bear weight through arms.
Ask the participant to lift their heel as much as possible while keeping their knee straight and maintain the position for 5 seconds.
Participant will perform 5 trials to complete the experiment with a washout period of 1 minute after each trial. Total time of trial is 16 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1. BMI 18.5 to 24.9
2. No history of musculoskeletal injuries (fracture, sprain, strain, subluxation).
3. Ability to perform heel rise variations independently. |
|
| ExclusionCriteria |
| Details |
1. Any lower limb asymmetry (Limb length discrepancy, muscle girth , decrease muscle strength) .
2. History of lower limb musculoskeletal injuries or surgery (recent injury , childhood injury ).
3. Flat feet and toe deformities, pathology, and/or pregnant.
4. History of metal implant .
o Any condition affecting neuromuscular function (ataxia ,poor sensation).
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 .SEMG of soleus onset timing
2. SEMG of Gastronemius lateralis onset timing
3. SEMG of tibialis anterior onset timing
4. SEMG of extensor hallucis longus onset timing |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. sEMG of soleus RMS
2. sEMG of gastrocnemius lateralis RMS
3. sEMG of tibialis anterior RMS
4. sEMG of extensor hallucis longus RMS |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/04/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
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
|
This study will assess the role of plantarflexors and dorsiflexors in the heel-rise action with the knee extended. Accurate sEMG data can inform the design of robotic exoskeletons and assistive devices that aim to enhance mobility and support recovery. Tele-rehabilitation systems can also benefit from detailed muscle activation profiles to monitor patient progress remotely. This is a crosssectional study focusing the role of muscle groups during standing and heel-rise action with knee extension. Assess the range of motion of the ankle to assure a sufficient range is present. will Demonstrate heel rise to the patient. Then stand or sit with a lateral view of the test limb to ascertain the height of the heel rise.
The starting position of the task is bilateral balanced standing. The subject is then asked to progress to dominant side single limb standing with the knee in extension. Then, the subject is likely to need external support; thus, fingers can be placed on the table, above shoulder height. Alternatively, no more than two fingers should be used on a table. The subject is then instructed to raise the heel of the dominant limb while maintaining the knee extension. Patient should not bear weight through arms.
Ask participant to lift heel as much as possible while keeping knee straight and maintain the position for 5 seconds. Participant will perform 5 trials to complete the experiment with washout period of 1 minute after each trail. |