NCT06657586

Brief Summary

The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2025

Completed
Last Updated

January 29, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

October 23, 2024

Last Update Submit

January 28, 2025

Conditions

Keywords

knee

Outcome Measures

Primary Outcomes (5)

  • Vertical jump

    My Jump Lab 3 is a mobile application that precisely measures and analyzes vertical jump performance. It is an important tool to assess lower limb function and optimize treatment processes for patients with knee problems. The app provides key performance metrics such as jump height, flight time and strength and helps monitor patients' progress.

    6 weeks

  • Star Balance Test

    It is a test that evaluates dynamic balance and lower limb stability. The subject stands on one foot on eight radial lines drawn on the ground and tries to reach the farthest point of each line with the free foot. Reach distances in each direction are recorded and analyzed. This test is used to determine the risk of injury in athletes and to monitor balance development during rehabilitation.

    6 weeks

  • Tegner Activity Level Scale

    The Tegner Activity Level Scale is used to determine individuals' physical activity and level of sporting participation. The scale uses a scale ranging from 0 (sedentary) to 10 (professional athlete). This scale is particularly useful in the rehabilitation of sports injuries and for monitoring individuals' activity levels

    6 weeks

  • KOOS-PS (Knee Injury and Osteoarthritis Outcome Score - Physical Function Short Form)

    The KOOS-PS is used to assess the physiological and functional effects of knee osteoarthritis and knee injuries. The KOOS-PS includes five different knee-related subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation, and Quality of Life. The physical function short form (PS) specifically assesses the impact of physical function on activities of daily living.

    6 weeks

  • WOMET (Western Ontario Meniscal Evaluation Tool)

    The WOMET is a specific scale developed to assess the symptoms and effects of meniscal injuries. It measures the pain, functional limitations, and impact on quality of life that patients experience with meniscal injuries.

    6 weeks

Study Arms (2)

neuromuscular exercises

EXPERIMENTAL

Patients in group 1 received conservative treatment and neuromuscular exercises performed by a physiotherapist.

Other: neuromuscular exercises

conservative treatment

ACTIVE COMPARATOR

Patients in group 2 received conservative treatment

Other: conservative treatment

Interventions

The exercise was applied in 18 sessions of 6 weeks.The treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods.

neuromuscular exercises

The treatment program included coldpack from cold application agent, ultrasound (US) treatment and TENS application from electrotherapy methods.

conservative treatment

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 20-65 years.
  • Having a meniscus tear.
  • Volunteering to participate in the study.

You may not qualify if:

  • Being diagnosed with a psychiatric illness.
  • Having a neurological disease that may interfere with treatment.
  • Having undergone meniscal surgery before.
  • Having received physical therapy in the knee area in the last 6 months.
  • Benefiting from any other treatment during the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

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

October 23, 2024

First Posted

October 24, 2024

Study Start

September 1, 2024

Primary Completion

November 1, 2024

Study Completion

January 20, 2025

Last Updated

January 29, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations