NCT05836792

Brief Summary

The aim of the randomized controlled study is to investigate the effects of the cycle ergometer with biofeedback on deep sensation in elderly people who has knee osteoarthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable knee-osteoarthritis

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

April 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

April 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 1, 2023

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

12 days

First QC Date

April 19, 2023

Last Update Submit

March 22, 2026

Conditions

Sensation DisordersKnee Osteoarthritis

Keywords

Knee OsteoarthritisDeep SensationCycle ErgometerBiofeedback

Outcome Measures

Primary Outcomes (3)

  • Diapason survey

    Diapason will be used to survey vibration sense to evaluate deep sensation

    3 weeks

  • Digital Goniometer

    Digital Goniometer will be used to measure angle of the knee position to evaluate deep sensation.

    3 weeks

  • 6 Minute Walking Test (6MWT)

    Six Minute walking test will be used to evaluate functional capacity of volunteers

    3 weeks

Secondary Outcomes (2)

  • The Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    3 weeks

  • Physical Activity Scale for the Elderly (PASE)

    3 weeks

Study Arms (2)

Cycle Ergometer Group (CEG)

EXPERIMENTAL

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound Cycle ergometer

Other: Cycle ErgometerDevice: Transcutaneous electrical nerve stimulationDevice: UltrasoundOther: Isometric exercises

Control Group

ACTIVE COMPARATOR

Isometric exercises Transcutaneous electrical nerve stimulation Ultrasound

Device: Transcutaneous electrical nerve stimulationDevice: UltrasoundOther: Isometric exercises

Interventions

Cycle ErgometerOTHER

Patients will attend cycle ergometer exercise. Volunteers will monitor their pedaling forces as right and left force. They will try to make these forces equal while they are pedaling.

Cycle Ergometer Group (CEG)
Isometric exercisesOTHER

The aim of the isometric exercises is increasing muscle strength. Each session patients will do quadriceps isometric exercises 5 times in a week for 3 weeks

Control GroupCycle Ergometer Group (CEG)
UltrasoundDEVICE

Ultrasound will be used for increase the permeability of cells to treat pain and inflammation. US will be used 5 times in a week for 3 weeks. Each procedure will take 5 minutes

Also known as: US
Control GroupCycle Ergometer Group (CEG)
Transcutaneous electrical nerve stimulationDEVICE

Transcutaneous electrical nerve stimulation will be used for the reduction of pain. TENS will be used 5 times in a week for 3 weeks. Each procedure will take 20 minutes.

Also known as: TENS
Control GroupCycle Ergometer Group (CEG)

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Knee osteoarthritis (Kellgren-Lawrance score between 1-3)

You may not qualify if:

  • Previous knee surgery
  • Diabetus Mellitus
  • Thyroid disease
  • Visual deficit
  • Gait disorder
  • Mental Disability
  • Presence of neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sante Medical Center

Istanbul, Kadıköy, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, KneeSensation Disorders

Interventions

Transcutaneous Electric Nerve StimulationUltrasonographyExercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and AnalgesiaDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

April 19, 2023

First Posted

May 1, 2023

Study Start

April 20, 2023

Primary Completion

May 2, 2023

Study Completion

June 30, 2023

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations

TU(1)