NCT05248854

Brief Summary

Tha aim of the study is to investigate the effects of core stabilization and sensorimotor exercise program on range of motion, proprioception, balance and functional status in patients with total knee arthroplasty. The study lasts prospective randomized controlled trial. Participants were randomly divided into sensorimotor training (SM,n=17) and core stabilization training group (CS,n=19). The exercise training program was administered for home exercise as 3-5 times a week and for a 6-week duration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2019

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 28, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

January 11, 2022

Last Update Submit

February 28, 2023

Conditions

Keywords

total knee replacementarthroplastybalancecore stabilizationsensorimotor training

Outcome Measures

Primary Outcomes (1)

  • Proprioception

    Joint Position Sense(JPS) was assessed to proprioception. JPS was evaluated via ability to reproduce joint angles using position-matching with active or passive movements (21, 22). Therapist showed each reference 30 and 60 degree flexion angles passively three times, held it for 10 second and returned to starting position during sitting. Then, patients were asked to show the target angles with eyes-closed, three deviated angles were recorded and the mean of errors was used for statistics

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

Secondary Outcomes (7)

  • Range of motion (ROM)

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

  • Sit to Stand Test

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

  • Timed up and Go Test

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

  • Berg Balance Test

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

  • KOOS Scale

    change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks

  • +2 more secondary outcomes

Study Arms (2)

Sensorimotor exercise training

EXPERIMENTAL

SM program included combination of traditional hip and knee exercise, various balance and proprioceptive exercises.

Other: Sensorimotor exercise training

Core Stabilization exercise training

EXPERIMENTAL

Core stabilization exercise program contained traditional hip and knee ROM exercise combining the core stabilization as mat activities

Other: Core stabilization exercise training

Interventions

The program included side stepping, tandem walking, perturbation exercise, overcoming mini obstacles, walking different surfaces and traditional hip and knee exercise. Participants applied these exercise as home program between postoperative second weeks and 8th weeks, 3-5 day /week , 20 25 min every session.

Also known as: SM exercises
Sensorimotor exercise training

Core stabilization exercise program was also prepared parallel to the sensorimotor training group intensity; the program contained traditional hip and knee exercise combining the core stabilization as mat activities depending on previous research.core stabilization exercise program was also prepared parallel to the sensorimotor training group intensity; the program contained traditional hip and knee exercise combining the core stabilization as mat activities depending on previous research

Also known as: CS exercises
Core Stabilization exercise training

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being volunteer,
  • age range,
  • being diagnosed with unilateral OA and undergoing unilateral TKA surgery

You may not qualify if:

  • having previous surgery history of lower limbs,
  • impaired hearing-vision -verbal problems, physical or mental disability,
  • having a neurological or oncologic disease that may affect functional performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeditepe University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Emrah DEMİRBAŞ, Operator

    Tuzla Gispir Hospital

    STUDY CHAIR
  • Şule BADILLI HANTAL, PhD

    Yeditepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know the their grup.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled trial , prospective, single bllinded.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

February 21, 2022

Study Start

November 28, 2019

Primary Completion

May 16, 2020

Study Completion

July 1, 2020

Last Updated

March 2, 2023

Record last verified: 2023-02

Locations