CTRI

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CTRI Number

CTRI/2024/05/067601 [Registered on: 17/05/2024] Trial Registered Prospectively

Last Modified On:

15/04/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

Impact of Calf Muscle Fatigue on Adult Balance and Function

Scientific Title of Study

Effect of calf muscle Fatigue on Balance and Functional test among 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	Tanya Gujral
Designation	Assistant Professor
Affiliation	GALGOTIAS UNIVERSITY
Address	Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	09311020220
Fax
Email	tanya.gujral@galgotiasuniversity.edu.in

Details of Contact Person
Scientific Query

Name	Tanya Gujral
Designation	Assistant Professor
Affiliation	GALGOTIAS UNIVERSITY
Address	Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	09311020220
Fax
Email	tanya.gujral@galgotiasuniversity.edu.in

Details of Contact Person
Public Query

Name	Tanya Gujral
Designation	Assistant Professor
Affiliation	GALGOTIAS UNIVERSITY
Address	Room No B-315, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar UTTAR PRADESH 203201 India
Phone	09311020220
Fax
Email	tanya.gujral@galgotiasuniversity.edu.in

Source of Monetary or Material Support

Research and Development cell,oom No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar

Primary Sponsor

Name	Research and Development cell Galgotias University
Address	Room No B-316, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No-2, Sector 17A,Opposite Buddha International Circuit, Greater Noida, Gautam Buddha Nagar
Type of Sponsor	Research institution

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
DR TANYA GUJRAL	Galgotias University	Room No E-004 Exercise Therapy Lab, Department of Physiotherapy, School of Allied Health Sciences, Galgotias University, Plot No 2, Sector 17A, Opposite Buddha International Circuit, Greater Noida Gautam Buddha Nagar UTTAR PRADESH	9311020220 gujraltanya14@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Departmental Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Physically active adults

Intervention / Comparator Agent

Type	Name	Details
Intervention	BALANCE AND FATIGUE ASSESSMENT	Nil
Comparator Agent	Nil	Not Applicable

Inclusion Criteria

Age From	18.00 Year(s)
Age To	35.00 Year(s)
Gender	Both
Details	BMI between 18.5-24.9 willing to participate voluntarily in the study by signing informed consent and not engaged in any major physical activity from last 6 months

ExclusionCriteria

Details

individuals with history of lower limb pain or back pain in last 6 months, subjects without any serious neurological history, evidence of any deformity at ankle, knee, hip and spine subjects who have lower limb surgery in last 6 months and with history of any instability in lower extremity in last 6 months.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Single leg balance test Y balance test time up and go and heel rise test for calf muscle fatigue	ASSESSED AT BASELINE MEASURE ,ONLY ONE TIME

Secondary Outcome

Outcome	TimePoints
NOT APPLICABLE	NOT APPLICABLE

Target Sample Size

Total Sample Size="200"
Sample Size from India="200"
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)

05/05/2027

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="2"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

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

The calf muscle played an important part as they are the prime postural muscle which determined stability and balance of the body, and their muscle was trained very frequently in clinical practice. Thus, it was important to know the duration of time throughout which the impact of calf muscular fatigue would continue to affect postural stability so that clinical assessment on postural stability would be done either before or after calf muscle exercise. Effects of fatigue in the muscles seemed to cause temporary postural instability, but objective measurements using postural stability tests, which are more ideal for use in a clinical setting, had not been well examined in relation to postural stability recovery after fatiguing exercise. It is unclear how severely acute muscular exhaustion affects balance in young subjects.