NCT07124429

Brief Summary

The femur, which forms the foundation of the lower extremity's skeletal system, is one of the most critical bones in the human body due to both its structural integrity and its functional duties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 11, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

2 months

First QC Date

August 9, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

femur

Outcome Measures

Primary Outcomes (6)

  • Muscle strength assessments

    Muscle strength assessments were performed using a MicroFET brand handheld dynamometer.

    8 weeks

  • Muscle shortness

    Muscle shortness was measured using standard clinical evaluation methods. The quadriceps femoris and hamstring muscles are major opposing groups in the thigh, while the tensor fasciae latae (TFL) is a key muscle involved in hip movements.

    8 weeks

  • Joint Range of Motion

    Joint range of motion measurements were evaluated separately for the right and left sides using a standard goniometer

    8 weeks

  • Muscle Reaction Time

    The BlazePod TTM (Play Coyotta Ltd.) device was used for the assessment of muscle reaction time. This device is a wireless system consisting of LED lights and a central controller, and it's designed to measure a participant's response time to specific light signals.

    8 weeks

  • Daily Living Activities

    Functional status was assessed using the Barthel Activities of Daily Living Index, which ranges from 0 (total dependence) to 100 (complete independence), with higher scores indicating a better outcome.

    8 weeks

  • Pain Assessment

    Participants' pain levels were evaluated using the Visual Analog Scale (VAS). All data was collected by a physiotherapist in a one-on-one session within a clinical setting and manually recorded on standard evaluation forms.

    8 weeks

Study Arms (2)

Reformer Pilates

EXPERIMENTAL

Reformer Pilates

Other: Reformer Pilates

conservative treatment

ACTIVE COMPARATOR

conservative treatment

Other: conservative treatment

Interventions

Reformer pilates is a form of exercise that uses a specialized machine with a sliding carriage and springs to provide resistance. It is highly effective for improving core strength, flexibility, and muscle tone while also promoting better posture and balance.

Reformer Pilates

Conservative physiotherapy is a treatment approach that aims to manage pain and improve function using non-surgical methods. This treatment often includes methods like applying hot packs to relax muscles and increase circulation, and using a TENS (Transcutaneous Electrical Nerve Stimulation) device to help relieve pain.

conservative treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 18 and 45 years
  • Male gender
  • Having undergone bilateral femoral lengthening surgery for cosmetic purposes only
  • The lengthening operation having been performed solely with the LON technique

You may not qualify if:

  • Female patients
  • Patients who have undergone unilateral femoral lengthening surgery
  • Patients under 18 or over 45 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahceşehir University Health Center

Istanbul, 34070, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Conservative Treatment

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 9, 2025

First Posted

August 15, 2025

Study Start

January 11, 2025

Primary Completion

March 11, 2025

Study Completion

September 17, 2025

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations