NCT05501197

Brief Summary

Our study will include 60 patients diagnosed with meniscus degeneration in the Department of Physiotherapy and Rehabilitation of the Faculty of Health Sciences of Marmara University. Volunteers will be informed about the purpose of the study and the evaluations and treatments to be carried out, and their consent will be obtained by reading the 'Informed Volunteer Consent Form' and obtaining their signatures. The sample group and distribution will be determined as 30 asynchronous telerehabilitation groups and 30 synchronous telerehabilitation groups. Our study is a randomized controlled trial. Groups will be formed in a randomized manner and blinded study design will be used to evaluate outcome parameters. Patients beginning the rehabilitation program will be evaluated at the start of the study, at week 4, week 8, and week 16. Demographic information of the patients participating in the study will be obtained using the demographic data form. Visual Analogue Scale (VAS) for pain, WOMET index for functionality and quality of life, functionality with Lysholm Knee Scoring Scale and quality of life with Patient Generated Index (PGI) and Short Form-12 (SF-12) scales; Functional mobility Timed Up and Go Test (TUG), functional capacity 2 Minutes Walk Test (2 MWT), balance Balance Master, proprioception and muscle strength Isokinetic assessment device, lower extremity neuromuscular function level 30 sec Sit Up and 5 Sit \& Go performance tests will be evaluated with Our study will investigate the comparison of the effects of asynchronous and synchronous telerehabilitation programs on pain, functional limitation, muscle strength and quality of life in patients with meniscal degeneration.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

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

August 8, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2023

Completed
Last Updated

August 15, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

August 12, 2022

Last Update Submit

August 12, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Lysholm score

    The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting.

    The The Lysholm score will be measured at baseline 2 minutes after pain assessment.

  • The Lysholm score

    The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting.

    The The Lysholm score will be measured at the end of intervention (8. week) 2 minutes after pain assessment.

  • Visual analogue scale (VAS)

    Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.

    The pain will be measured at baseline

  • Visual analogue scale (VAS)

    Pain will be measured using a 10 cm visual analogue scale (VAS). The participants places a mark on the line that best represented their perception of pain at that instant. The VAS score will be measured in cm from the left hand end of the line to the mark.

    The pain will be measured at the end of intervention (8. week).

Secondary Outcomes (8)

  • 12-Item Short Form Survey (SF-12)

    The SF-12 will be measured at baseline 2 minutes after The Lysholm score assessment.

  • 12-Item Short Form Survey (SF-12)

    The SF-12 will be measured at the end of intervention (8. week) 2 minutes after The Lysholm score assessment.

  • 30 Seconds Sit To Stand Test

    The 30 Seconds Sit To Stand Test will be measured at baseline 2 minutes after SF-12 assessment.

  • 30 Seconds Sit To Stand Test

    The 30 Seconds Sit To Stand Test will be measured at the end of intervention (8. week) 2 minutes after SF-12 assessment.

  • 2 Minute Walk Test

    The 2 Minute Walk Test will be measured at baseline 5 minutes after 30 Seconds Sit To Stand Test assessment.

  • +3 more secondary outcomes

Study Arms (2)

Synchronous Telerehabilitation Group

ACTIVE COMPARATOR

Synchronous Telerehabilitation Group will receive exercise therapy via video conference.

Other: Exercise Therapy via video conference

Asynchronous Telerehabilitation Group

EXPERIMENTAL

Asynchronous Telerehabilitation Group will receive exercise therapy via mobile application.

Other: Exercise Therapy via mobile application

Interventions

The intervention will include the different levels of the following exercises that are given to the patient considering their functional level: Straight leg raise (Level 1-2-3) Quadriceps strengthening (Level 1-2-3) Hip abductor/adductor strengthening (Level 1-2-3) Hamstring stretch Gastrocnemius stretch

Also known as: Therapeutic Exercise
Synchronous Telerehabilitation Group

The intervention will include the different levels of the following exercises that are given to the patient considering their functional level: Straight leg raise (Level 1-2-3) Quadriceps strengthening (Level 1-2-3) Hip abductor/adductor strengthening (Level 1-2-3) Hamstring stretch Gastrocnemius stretch

Also known as: Therapeutic Exercise
Asynchronous Telerehabilitation Group

Eligibility Criteria

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

You may qualify if:

  • Pain less than or equal to 7 according to VAS
  • Individuals aged 18-65
  • Patients with independent mobility

You may not qualify if:

  • Patients who have undergone surgery in the last 1 year
  • Patients who have undergone total knee replacement or total hip replacement surgery
  • Patients with acute trauma in the last 1 year
  • Patients with uncontrolled chronic disease
  • Patients who have received physical therapy in the last 6 months
  • Patients who have received hyaluronic acid and corticosteroid injections in the last 6 months
  • Patients with a respiratory condition that interferes with walking will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Central Study Contacts

Aysel Yıldız, Ph.D.

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

August 8, 2022

Primary Completion

December 27, 2022

Study Completion

April 15, 2023

Last Updated

August 15, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share