NCT05233839

Brief Summary

The aim of the study is to compare the home exercise program performed with video-based telerehabilitation in patients with degenerative meniscal injury, and the home exercise program performed with one-on-one training in the hospital with conventional methods.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

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

First Submitted

Initial submission to the registry

January 13, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2022

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

January 13, 2022

Last Update Submit

August 27, 2022

Conditions

Keywords

Degenerative meniscus injuryTelerehabilitation

Outcome Measures

Primary Outcomes (5)

  • Visual Analog Scale (VAS)

    On a 10 cm straight line or numerical scale (0: no pain, 10: unbearable pain).

    Change from Baseline VAS at 8 weeks

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    WOMAC consists of 3 main headings: pain intensity, stiffness, and physical function. The total score ranges from 0 (no disability) to 96 (complete disability).

    Change from Baseline WOMAC at 8 weeks

  • SF-12

    SF 12 is a self-evaluation scale. It consists of seven items. Its score ranged from 0 to 100, with higher scores indicating better physical and mental health functioning.

    Change from Baseline SF-12 at 8 weeks

  • Muscle Strength Test with Lafayette Hand Held Dynamometer

    It is an objective muscle strength measurement tool. Measurements are made 3 times. A rest of 120 seconds is given between measurements. The highest measured value is noted.

    Change from Baseline Dynamometer Value at 8 weeks

  • Proprioception Measurement with Baseline Bubble Inclinometer

    The "absolute angle difference", which is the difference between the targeted angle and the angle realized by the patient in each repetition, is recorded. The arithmetic mean of the absolute angle difference of 3 repetitions is the result data.

    Change from Baseline Inclinometer Value at 8 weeks

Secondary Outcomes (2)

  • EARS

    Change from Baseline EARS at 8 weeks

  • TSUQ

    Change from Baseline TSUQ at 8 weeks

Study Arms (2)

Telerehabilitation (TR)

EXPERIMENTAL

The TR group will be followed up through the application within the 8-week home exercise program.

Other: Telerehabilitation

Paper Based Rehabilitation (PBR)

ACTIVE COMPARATOR

The PBR group will be followed up through the paper instruction within the 8-week home exercise program.

Other: Paper Based Rehabilitation

Interventions

Application based video home exercise for the degenerative meniscus injury

Telerehabilitation (TR)

Paper instruction based home exercise for the degenerative meniscus injury

Paper Based Rehabilitation (PBR)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients aged 18 - 65 years
  • Having been diagnosed with degenerative meniscus injury by an orthopedist by MRI examination
  • Having signed the consent form

You may not qualify if:

  • Situations that will prevent assessments or communication with the individual
  • Having an operation due to degenerative meniscus injury problem
  • Orthopedic and neurological problems that would prevent evaluation and/or treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Muğla Sıtkı Koçman Training and Research Hospital

Muğla, Menteşe, 48000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • İsmet Tümtürk, BSc

    Ege University

    PRINCIPAL INVESTIGATOR
  • Cem Yalın Kılınç, PhD

    Muğla Sıtkı Koçman University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2022

First Posted

February 10, 2022

Study Start

March 15, 2022

Primary Completion

June 30, 2022

Study Completion

July 15, 2022

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations