NCT03470090

Brief Summary

This study was planned to evaluate the effect of neuromuscular exercise program on physical activity, functionality and balance in patients with knee osteoarthritis aged 35-65 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

June 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

March 12, 2018

Last Update Submit

March 19, 2018

Conditions

Keywords

Physical activityFunctionBalanceNeuromuscular exercisesOsteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Change from Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) of patients with knee osteoarthritis at 6 weeks.

    The scale used to measure knee function (0-100 total score). High scores indicate poor function status and low scores indicate good function status. The scale contains 24 questions, three subgroups of pain, stiffness and physical function. There are 5 alternative answers to the questions: 0 = no, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The rating (total of all answers / 96) was calculated as \* 100.

    6 weeks

Secondary Outcomes (4)

  • Changed from Visual Analog Scale (VAS) of patients with knee osteoarthritis at 6 weeks.

    6 weeks

  • Change from International Physical Activity Questionnaire (IPAQ) Short Form of patients with knee osteoarthritis at 6 weeks.

    6 weeks

  • Change from Y Balance Test of patients with knee osteoarthritis at 6 weeks.

    6 weeks

  • Change from 2000 International Knee Documentation Committee (IKDC) of patients with knee osteoarthritis at 6 weeks.

    6 weeks

Study Arms (2)

Neuromuscular Exercises Group

EXPERIMENTAL

This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and neuromuscular exercises training

Behavioral: Neuromuscular Exercises

Conventional Group

ACTIVE COMPARATOR

This group of patients received patient with knee osteoarthritis. It will be applied classical physiotherapy and conventional exercises.

Behavioral: Conventional Group

Interventions

In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations. The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control. NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.

Neuromuscular Exercises Group

In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.

Conventional Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with knee osteoarthritis,
  • individuals without a physical disability,
  • person in an age range 35- 65 years,
  • Having no any knee surgeon,
  • Mentally that is sufficient to make assessments,
  • Who want to be involved voluntary work,
  • Ability to adjust the training program
  • Individuals who received informed consent

You may not qualify if:

  • Individuals who do not allow mental evaluation
  • Individuals who do not want to be involved in voluntary work.
  • Clinical study refused to participate in.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Malatya Gozde Hospital

Malatya, 44100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityOsteoarthritis

Condition Hierarchy (Ancestors)

BehaviorArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Burcu Talu, PhD

    Inonu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants didn't know taking which exercise treatment methods.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Experimental, Randomized Controlled Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asistant Professor

Study Record Dates

First Submitted

March 12, 2018

First Posted

March 19, 2018

Study Start

June 1, 2017

Primary Completion

September 30, 2017

Study Completion

December 16, 2017

Last Updated

March 21, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share

Locations