NCT04969432

Brief Summary

The current study was conducted to comparison of the Client-centered (CC) intervention with face-to-face (FF) and TR methods after Total Knee Arthroplasty (TKA). The pilot study was planned to examine the impact of the CC intervention on quality of life, perceived occupational performance and satisfaction. The current study was designed according to the CONSORT statement, which provides a standardized method for randomized controlled trial (RCT) design. Approval for the study was granted by the Local Ethics Committee. Written informed consent was obtained from all participants prior to the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

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

January 7, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 8, 2021

Last Update Submit

July 16, 2021

Conditions

Keywords

Client-centeredQuality of lifeKnee arthroplastyOccupational performanceTelerehabilitationTelemedicine

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    40 minutes

  • Nottingham Health Profile

    10 minutes

Study Arms (2)

Telerehabilitation

EXPERIMENTAL
Other: Client-centered

Face-to-face

EXPERIMENTAL
Other: Client-centered

Interventions

Rehabilitation

Face-to-faceTelerehabilitation

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age between 65 and 75 years
  • Mini Mental State Examination score of ≥24
  • Education level of at least completion of elementary school
  • Having undergone unilateral TKA surgery
  • Access to technological equipment
  • Ability to understand and follow verbal instructions

You may not qualify if:

  • Revision surgery
  • Having any chronic disease that will affect the rehabilitation process
  • Auditory and visual problems that may affect rehabilitation implementation and communication
  • Postoperative complications (e.g., nerve injury and deep vein thrombosis)
  • Attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Ankara, Turkey (Türkiye)

Location

Related Publications (1)

  • Torpil B, Kaya O. Effectiveness of client-centered intervention delivered with face-to-face and telerehabilitation method after total knee arthroplasty-A pilot randomized control trial. Br J Occup Ther. 2022 Jun;85(6):392-399. doi: 10.1177/03080226211070477. Epub 2022 Feb 28.

MeSH Terms

Interventions

Person-Centered Psychotherapy

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 8, 2021

First Posted

July 20, 2021

Study Start

January 7, 2021

Primary Completion

May 30, 2021

Study Completion

May 30, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations