NCT06070220

Brief Summary

The current study was conducted to effectiveness of the Client-centered (CC) intervention after Total Hip Arthroplasty (TKA). The current 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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

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

July 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

September 30, 2023

Last Update Submit

October 16, 2023

Conditions

Keywords

Client-centeredQuality of lifeOccupational performanceHip arthroplasty

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    The Canadian Occupational Performance Measure (COPM) was used to identify occupations where participants had problems with ADLs and to determine the perceived occupational performance and satisfaction level in these occupations. In the COPM, which was designed with the semi-structured interview method, firstly, the occupations in which the participants experience problems in the areas of self-care, productivity and free time are determined by giving importance points with a 1-10 Likert type scoring system. The higher the score, the higher the performance and satisfaction level.

    40 minutes

  • Nottingham Health Profile

    Nottingham Health Profile Nottingham Health Profile (NHP) is a 38-item quality of life survey that measures individuals' perceived health problems and the extent to which these health problems affect ADLs. It consists of 6 sub-dimensions and each sub-dimension consists of 0-100 points (0 points indicate good health status-100 points indicate poor health status): energy (3 items), pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), and physical activity (8 items). The Turkish version of the NHP was used to evaluate the health-related quality of life.

    10 minutes

Study Arms (2)

client-centered intervention group

EXPERIMENTAL
Behavioral: traditional occupational therapy intervention and client-centered intervention

control group

EXPERIMENTAL
Behavioral: Traditional occupational therapy intervention

Interventions

Traditional occupational therapy intervention and client centered intervention were given to the participants. CC intervention is a dynamic approach that involves a systematic therapy process, that is, in which the participant and the therapist are active in the treatment process. In the current study, a treatment program was designed over a maximum of 5 occupations in which participants evaluated after THA indicated problems in activities of daily living according to COPM. This systematic and dynamic program consists of 4 phases: (1) client-centered goal setting, (2) negotiating an intervention plan, (3) the actual intervention, (4) an evaluation of the outcome and finally reporting to relevant others.

client-centered intervention group

The following training procedure, which included exercise, transfer activities and home arrangements, was followed in common in both groups: 1. st day: After the operation, exercises to strengthen the muscles of the participants (thigh, hip and trunk muscles) were explained verbally and visually. Each exercise consists of 3 sets of 12 repetitions. Exercises were updated in bed, sitting or standing, depending on the participant's functional status, pain and fatigue. Additionally, transfer activities training was provided. 2. nd day: The exercises taught to the participants on the first day were repeated. Following these exercises, participants were given verbal instructions on gait training, and then gait training began. According to the pain and fatigue status of the participants, gait exercises were continued. 3. rd day: The work done on the first and second day was repeated. Pre-discharge home arrangements training was provided.

control group

Eligibility Criteria

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

You may qualify if:

  • (1) Being 65 years of age or older,
  • (2) Mini Mental State Examination score of ≥ 24,
  • (3) having undergone unilateral total hip replacement,
  • (4) education level of at least completion of elementary school,
  • (5) ability to understand and follow verbal instructions,
  • (6) volunteer to participate in the study

You may not qualify if:

  • (1) revision surgery,
  • (2) having any chronic disease that will affect the rehabilitation process,
  • (3) auditory and visual problems that may affect rehabilitation implementation and communication,
  • (4) postoperative complications (e.g. nerve injury and deep vein thrombosis), and
  • (5) attendance of any rehabilitation program (physiotherapy, speech therapy, psychotherapy, etc.) before and during the study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 30, 2023

First Posted

October 6, 2023

Study Start

July 1, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations