- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07716150
Reliability of Custom-Made Platform for Trunk Flexion Isometric Strength Assessment
Reliability of Custom-Made Platform for Trunk Flexion Isometric Strength Assessment in Healthy Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The custom-made platform is a standing device designed to measure maximal voluntary isometric trunk flexion force. During testing, participants stand on the platform and lean forward to a standardised angle of 17.5 degrees of trunk flexion. A trunk belt connected to a handheld dynamometer fixed to the rear platform records the force generated when the participant pushes forward against the belt during a maximal isometric contraction. Force is recorded in Newtons using Biopac Student Lab Pro software through the MP36 data acquisition unit.
A cross-sectional test-retest reliability design will be employed. Twenty-nine healthy male participants aged 18-25 years will be recruited from Riphah International University using non-probability convenience sampling. Each participant will attend two identical testing sessions spaced one week apart, conducted at the same time of the day to control for diurnal variation in muscle strength. During each session, participants will perform three maximal voluntary isometric trunk flexion contractions of five seconds duration, with sixty seconds of passive rest between trials. The average force across the three trials will be recorded in Newtons and used as the primary outcome variable for analysis.
Reliability will be assessed using the Intraclass Correlation Coefficients with two-way random effects model for absolute agreement, single measures - ICC (2,1) - reported alongside the 95% confidence interval. Values below 0.50 will be interpreted as poor reliability, 0.50 to 0.75 as moderate, 0.75 to 0.90 as good, and above 0.90 excellent. Absolute reliability will be quantified using the Standard Error of Measurement and the Minimal Detectable Change at 95% confidence level. Bland-Altman analysis will be used to assess systematic bias and limits of agreement between sessions. A paired t-test or Wilcoxon signed-rank test, depending on normality assessed by the Shapiro-Wilk test, will determine whether a statistically significant learning effect exists between Session 1 and Session 2. All statistical analyses will be conducted using SPSS Version 30 at a significance level of 0.05.
If the platform demonstrates good to excellent reliability, it will be validated as a feasible and affordable alternative to isokinetic dynamometry for trunk flexion isometric strength assessment, with direct implications for physiotherapy practice and sports science research in Pakistan.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Syeda Farwa Abid, DPT
- Phone Number: +923130547217
- Email: farwasyedsptofficial@gmail.com
Study Locations
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Islamabad, Pakistan, 44000
- Recruiting
- Riphah International University
-
Contact:
- Farwa Abid, DPT
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy males
- Age between 18 and 25 years
- Non-athletes
- No history of musculoskeletal injuries specifically in the trunk region
Exclusion Criteria:
- History of any medical condition that would affect trunk muscle strength
- Athletes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Reliability of Custom-Made Platform for Trunk Flexion Isometric Strength Assessment
Healthy adult participants will undergo repeated trunk flexion isometric strength assessments using a custom-made testing platform.
Measurements will be repeated under standardized conditions by the same examiner to assess the reliability of the platform.
No intervention will be administered.
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Participants stand at 17.5° trunk flexion and perform 3 maximal isometric contractions of 5 seconds against a belt-connected dynamometer.
Force recorded in Newtons.
Repeated one week later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Trunk muscles isometric strength
Time Frame: 1 week.
|
Participants stand at 17.5° trunk flexion and perform 3 maximal isometric contractions of 5 seconds while attached to a dynamometer connected via a specalized harness.
Force recorded in Newtons.
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1 week.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Saad Rauf, PhD, Riphah Interntional University, Isra University, Islamabad
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REC/MS-PT/02196 Farwa Abid
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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