NCT04165187

Brief Summary

The aim of this study is to investigate the effect of Body Awareness Therapy (BAT) on pain, balance and functional capacity in patients with knee osteoarthritis. Individuals will divided into two groups: training group and control group. Both groups will receive exercise training as a home program. Individuals in study group will participate in BAT training 3 days for 6 weeks. Assessments will be made before and after the 6-week study program.

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 Jan 2020

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

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2020

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

November 13, 2019

Last Update Submit

June 29, 2020

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritisbody awareness therapypainfunctional capacity

Outcome Measures

Primary Outcomes (6)

  • Visual analog scale

    change in knee pain intensity from baseline at 6 weeks,"0" point means that there is no pain, "10" point indicates severity of pain

    six weeks

  • Single leg stability

    change in overall stability index of athlete single leg stability test in Biodex Balance System (BBS) from baseline at 6 weeks. Stability level of platform will be set as static. The results can be compared with normative values in the BBS. Lower scores indicate better stability and higher scores mean poor balance.

    six weeks

  • 6 minute walk test

    change in walking distance from baseline at 6 weeks

    six weeks

  • 5 times sit to stand test

    change in time needed to complete the test from baseline at 6 weeks

    six weeks

  • Stair climb test

    change in time needed to complete the test form baseline at 6 weeks

    six weeks

  • Hand-held dynamometer

    changes quadriceps muscle strength from baseline at 6 weeks

    six weeks

Secondary Outcomes (3)

  • Western Ontario and McMaster Universities osteoarthritis index (WOMAC)

    six weeks

  • Fall risk

    six weeks

  • joint range of motion

    six weeks

Study Arms (2)

BAT+Home exercise program

EXPERIMENTAL

The patients in this group will participate in BAT for 3 days a week for 6 weeks in addition to home exercise program.

Other: Body Awareness TherapyOther: Home exercise program

Home exercise program

ACTIVE COMPARATOR

The patients in the control group will perform home exercise program, two times a day, 7 days a week for 6 weeks.

Other: Home exercise program

Interventions

Body Awareness TherapyOTHER

Body scanning, stretch-release movements, centralization, contact with the ground, postural stability, movement flow and free breathing will be performed during sessions in lying, sitting and standing positions.

BAT+Home exercise program
Home exercise programOTHER

Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.

BAT+Home exercise programHome exercise program

Eligibility Criteria

Age45 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary knee Osteoarthritis
  • Stage 2 -3 according to Kellgren - Lawrence Classification

You may not qualify if:

  • Previous surgery in the lower extremity
  • Neuromuscular disease
  • Vestibular pathology
  • Physiotherapy intervention or intra-articular injection within the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Eyup, Turkey (Türkiye)

Location

Related Publications (1)

  • Alpay K, Sahin M. Effects of basic body awareness therapy on pain, balance, muscle strength and functionality in knee osteoarthritis: a randomised preliminary trial. Disabil Rehabil. 2023 Dec;45(26):4373-4380. doi: 10.1080/09638288.2022.2151650. Epub 2022 Nov 29.

    PMID: 36444879DERIVED

MeSH Terms

Conditions

Osteoarthritis, KneePain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kubra Alpay

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Pysiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

January 1, 2020

Primary Completion

May 30, 2020

Study Completion

June 20, 2020

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)