Effects of Sensorimotor and Core Stabilization Exercises After Total Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Effects of Sensorimotor and Core Stabilization Exercise Programs Following Total Knee Arthroplasty : A Randomize Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05248854
• Other study ID #: YeditepeUPT
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2023
• Source: Yeditepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Objective :

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.

Design :

Prospective randomized controlled trial

Subjects :

A total of 36 Ostearthritis patients (69.8 ± 5.1 years) who underwent unilateral knee arthroplasty. Participants were performed TKA surgery by the same physician and followed by the same therapist.

The following inclusion criteria were used: being volunteer, 50-85 age range, being diagnosed with stage 4 OA and undergoing unilateral TKA surgery. The following exclusion criteria were applied: having previous surgery history of affected lower limb, impaired hearing, vision or verbal problems, physical or mental disability, having a neurological or oncologic disease that may affect functional performance.

Patients who met inclusion criteria and were willing to join the study (n=52) were evaluated after being diagnosed with OA and before the operation at the clinic. A total 40 patients undergoing TKA surgery participated in our study and were randomly separated to the Sensorimotor Training Group (SM, n=20) and the Core Stabilization Training Group (CS, n=20). Group allocation was randomized in two blocks of 40 sealed envelopes without external marks, which were mixed and numbered from 1 to 40, containing a piece of paper with the group allocation. All participants were blinded to the treatment type. As a result, 36 patients completed the process.

Outcome Measures :

Patients were assessed on three separate occasions (presurgery, 2 weeks and 8 weeks postsurgery). The primary outcome was proprioception and seconder outcomes were range of motion, Knee Injury and Osteoarthritis Outcome Scale (KOOS), Berg Balance Test, Timed-up & Go test and Sit & Stand -Up tests.

Interventions :

Participants were randomized into two intervention groups: sensorimotor training group (SM, n=17) and Core Stabilization training group (CS, n=19). Both groups were prescribed a 6-week home based exercise programme for 3-5 sessions/week between 2 and 8 weeks postsurgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 1, 2020
• Est. primary completion date: May 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• being volunteer,

• 50-85 age range,

• being diagnosed with unilateral OA and undergoing unilateral TKA surgery

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Arthroplasty
• Joint Replacement
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Sensorimotor exercise training
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.
• Core stabilization 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

Locations

Country	Name	City	State
Turkey	Yeditepe University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Yeditepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Range of motion (ROM)	The ROM of knee and hip joints were assessed bilaterally via a universal goniometer.	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	Sit to Stand Test	The STS test was applied by recording the elapsed time between the patients who were asked to sit and stand up 5 times as fast as possible	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	Timed up and Go Test	In the TUG test, patients were asked to stand up independently from the chair, walk 3 m, turn around and sit at the starting point; the time elapsed between them was recorded (25). The minimum 2.49 seconds change indicates good clinical properties and below the 14 sec during performance indicate higher risk of falling.	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	Berg Balance Test	Berg Balance Test was also used to assess the static balance and falling risk of the participants. The test includes 14 different tasks scored between 0-4 points. Total scores were recorded between 0-56 points, higher score indicates better balance level	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	KOOS Scale	KOOS consists of 42 items and five subscales: pain, symptom, activities of daily life, quality of life, sport and recreation. All questions are scored 0-4 points and subscales points are converted separately to 0-100 points. Higher point indicates no knee problems	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	Tampa Scale of Kinesiophobia	Consist of 17 items, evaluate the fear of movement.	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks
Secondary	Oswestry Low Back Disability Questionnaire	The Oswestry Disability Index is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.	change from baseline to postsurgery second weeks , change from postsurgery second weeks to eighth weeks