NCT03615521

Brief Summary

The aim of this study is to investigate the effects of 6-week physiotherapy and rehabilitation programs involving different 'Proprioceptive Neuromuscular Facilitation' (PNF) techniques in patients with knee osteoarthritis on pain, proprioception, postural control, muscle strength, range of motion and knee functions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 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

First Submitted

Initial submission to the registry

December 11, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 10, 2021

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

3.3 years

First QC Date

December 11, 2017

Last Update Submit

February 22, 2022

Conditions

Muscle WeaknessBalance DisordersKnee PainKnee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Quadriceps Femoris Muscle Strength

    Quadriceps Femoris muscle strength is evaluated Biodex System. Patients performs knee extension strongly and system analyzed. System gives us Peak Torque which indicates the muscle's maximum strength capability. 1 repetition maximum (RM) isotonic strength test.

    6 week

Secondary Outcomes (8)

  • Knee Proprioception (30-45 and 60 degree)

    6 week

  • KOOS score

    6 week

  • Step test

    6 week

  • Womac Score

    6 week

  • 6 Minute walking test

    6 week

  • +3 more secondary outcomes

Other Outcomes (1)

  • Time up and go test

    6 week

Study Arms (3)

Repeated Contraction Exercise Group

EXPERIMENTAL

Repeated Contractions Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute and Repeated Stretch (Repeated Contractions) exercise. Repeated Contractions exercise is type of Proprioceptive Neuromusculer Facilititation Exercise. 3 session for 6 weeks.

Other: HotpackOther: UltrasoundOther: Repeated Contraction Exercise

Combine Exercise Group

EXPERIMENTAL

Combination of Isotonics Exercise Group, Hotpack apply for knee 20 minute, Ultrasound is a termal ajan which use for 10 minute Combination of Isotonics Exercise. Combination of Isotonics Exercise is type of PNF. Combined concentric, eccentric, and stabilizing contractions of one group of muscles (agonists) without relaxation. 3 Session for 6 weeks.

Other: HotpackOther: UltrasoundOther: Combine Exercise

Standart Exercise Therapy

EXPERIMENTAL

Classic Physiotherapy: Hotpack, Ultrasound, Standart exercise program to improve Quadriceps, Hamstring and hip muscle strength. 3 session for 6 weeks.

Other: HotpackOther: UltrasoundOther: Standart Exercise Therapy

Interventions

HotpackOTHER

Hotpack applied 20 minutes for knee 3 session for 6 weeks

Combine Exercise GroupRepeated Contraction Exercise GroupStandart Exercise Therapy
UltrasoundOTHER

Ultrasound applied 10 minutes for knee 3 session for 6 weeks

Combine Exercise GroupRepeated Contraction Exercise GroupStandart Exercise Therapy
Combine ExerciseOTHER

Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week

Combine Exercise Group
Repeated Contraction ExerciseOTHER

Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week

Repeated Contraction Exercise Group
Standart Exercise TherapyOTHER

Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise. 3 session for 6 week

Standart Exercise Therapy

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between the ages of 45-65
  • The diagnosis of stage 1-2 osteoarthritis by the orthopedist
  • Volunteerig for research
  • No hearing, vision and speech impediment

You may not qualify if:

  • Patients with intra-articular contracture,
  • No Meniscus and no ligament problems
  • Presence of any neurological or cardiopulmonary disease that may affect the results of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Muscle WeaknessOsteoarthritis, Knee

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsOsteoarthritisArthritisJoint DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Filiz Can, Prof.

    Hacettepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

December 11, 2017

First Posted

August 6, 2018

Study Start

January 20, 2018

Primary Completion

May 20, 2021

Study Completion

November 10, 2021

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

TU(1)