NCT06821477

Brief Summary

The main objective of this study is to evaluate quadriceps thigh muscle activity during active straight leg raise (ASLR) with a knee brace. An additional aim of the study is to evaluate quadriceps activity during straight leg raise with a knee brace in a variable command and manner of task performance. The study will be conducted on a group of healthy individuals aged 18 - 35 years. Height and weight were measured using a scale and centimetre tape. Then, according to the study protocol, specific measurements will be taken of the rectus femoris, medial vastus and lateral vastus muscles using surface EMG of a non-invasive nature. Study participants will undergo the following measurements:

  1. 1.Measurement of the MVIC (maximum voluntary isometric contraction) of the quadriceps of the thigh, in a sitting position with the lower leg flexed to 90 degrees and in knee extended (0 degrees).
  2. 2.Measurement of muscle activity during elevation of the straightened lower limb in a supine position without an orthosis.
  3. 3.Measurement of muscle activity during straight leg raise in supine position with knee brace (default and different commends).

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

February 3, 2025

Last Update Submit

July 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison between RF from p1 (ASLR without orthosis) to RF from p2 (ASLR with orthosis, without any command)

    It was decided to choose RF and generalize it to whole quadriceps femoris, thus decide what is the impact of the extension brace on EMG quadriceps signal

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Muscle (RF, VLO, VMO) comparison between trials and inside every trial

    through study completion, an average of 1 year

Other Outcomes (1)

  • Comparison between analysis made with normalization to MVIC done in 90 degrees (standard) and done in 0 degrees (full extension).

    through study completion, an average of 1 year

Study Arms (1)

20 healthy young people

* age between 18-35 years * no contraindications to exercise * ability to perform the required commands without pain or discomfort * full range of motion of the knee joint.

Other: Superficial EMG

Interventions

Superfiscial EMG during ASLR without knee brace follow by EMG during ASLR with knee brace under certain commands

20 healthy young people

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

young healthy people 18-35 years old

You may qualify if:

  • age between 18-35 years
  • no contraindications to exercise
  • ability to perform the required commands without pain or discomfort
  • full range of motion of the knee joint.

You may not qualify if:

  • those with a history of knee and/or hip surgery
  • damage to ligamentous structures of the knee joint in the past treated conservatively or meniscus treated conservatively.
  • muscle and tendon injury of the knee joint area in the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jozef Pilsudski University of Physical Education

Warsaw, 01-813, Poland

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc PT

Study Record Dates

First Submitted

February 3, 2025

First Posted

February 12, 2025

Study Start

February 3, 2025

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD), including raw EMG data from electrodes and processed data normalized as %MVIC for statistical analysis, will be available upon reasonable request after primary results publication. Data will be anonymized to protect participant confidentiality and shared following ethical guidelines. Requests may be submitted to the corresponding author for up to 5 years post-publication.

Shared Documents
SAP, CSR
Access Criteria
Raw EMG data are available on reasonable request. We request investigators to contact us directly to discuss data sharing. On reasonable request statistical protocol and code for R or Python are available.

Locations