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Arthritis KneeNCT04969432

Effectiveness of Client-centered Intervention in After Total Knee Arthroplasty

A study testing Client-centered in people with Arthritis Knee, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 75 years
Conditions the study is for
Arthritis Knee
What is being tested?
Client-centered
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteTurkey (Türkiye)
Study dates
7 Jan 2021to 30 May 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • University of Health Sciences Turkey

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: Effectiveness of Client-centered Intervention Delivered With Face to Face and Telerehabilitation Method After Total Knee Arthroplasty - A Pilot Randomized Controlled Trial

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.

Read the detailed description

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.

Participants A total of 56 older adults who were admitted to the occupational therapy department of a public university between January 2021 and May 2021 were screened. Participants who were eligible according to the evaluation and inclusion-exclusion criteria one week after TKA were included in the study. The study inclusion criteria were: (1) age between 65 and 75 years; (2) Mini Mental State Examination score of ≥24; (3) education level of at least completion of elementary school; (4) having undergone unilateral TKA surgery; (5) access to technological equipment; and (6) ability to understand and follow verbal instructions. The exclusion criteria were defined as: (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.) during the study period.

Measurement The demographic characteristics of the participants were recorded, including age, sex, education level, body mass index (BMI), other people in the house where they lived, and marital status. The Mini Mental State Examination was used to determine the cognitive status included in the inclusion criteria. The Canadian Occupational Performance Measure and the Nottingham Health Profile were applied to all the subjects twice, before and after intervention.

Assessments Mini Mental State Examination Mini Mental State Examination (MMSE), which was used in the inclusion criteria of the study, was used to determine the cognitive state of the participants. From a maximum total of 30 points, a score of 24 is accepted as the threshold value, with scores below this value indicating problems in cognitive functions. Turkish validity and reliability studies of the test have been conducted and the researcher found the MMSE positive and negative predictive values .90 and .95 respectively and kappa score .86.

Canadian Occupational Performance Measure The Canadian Occupational Performance Measure (COPM) is a measure that determines the problems faced by individuals in the field of occupational performance through a semi-structured interview. Occupational performance problems are evaluated with self-reported performance and satisfaction scores. In the first step, ADL problems experienced by individuals in the areas of self-care, productivity and leisure are determined and each occupation is scored according to importance. The subject then selects a maximum of 5 occupations according to their importance scores and gives performance and satisfaction scores in a Likert-type system of 1- 10 for each occupation. The overall performance and satisfaction scores are obtained as the total of the performance and satisfaction scores of each occupation divided by the number of occupations. The Turkish version of COPM was used to evaluate the perceived occupational performance and satisfaction. The Turkish adaptation performed and test re-test reliability of Turkish version of COPM performance was .988 and satisfaction .986, indicating excellent reliability.

Nottingham Health Profile The Nottingham Health Profile (NHP) is a general quality of life questionnaire that measures perceived health problems and the level of these problems affecting normal ADL. The questionnaire consists of 38 items related to health status. Each item is answered as yes or no, and each section is scored between 0-100, with 0 indicating the best health status, and 100, the worst health status. In the Turkish adaptation study, test-retest reliability of the subscales (dimensions) of the scale varied between 0.70 and 0.92, and internal consistency values ranged between 0.56 and 0.87, confirming its validity and reliability.

Intervention The intervention program which was used both method (TR and FF) is designed to consist of 4 weeks, 4 days a week, 45-minute sessions. The caregiver actively participated in the treatment in order to prevent any possible injuries and to perform the applications more smoothly during the entire intervention process. The FF method was performed in the occupational therapy unit. The CC interventions with TR were delivered through real-time interaction programs such as Zoom, Skype, WhatsApp video call, or Microsoft Teams, according to the preference of the patient.

Client-centered intervention

The CC intervention developed according to the literature and based on a systematic therapy process, characterized by an active participatory attitude of both the participants after TKA process and the therapist, consisted of 5 phases: (1) CC goal-setting, (2) negotiating a therapy plan, (3) the actual intervention, (4) an evaluation of the outcome and (5) finally reporting to relevant others. The key aspect of this intervention was the CC approach in which the therapist is trained to clarify the prioritized goals of the patient. The therapy procedure was implemented according to the prioritized goals determined in the COPM. The stages are explained below:

First stage: Setting a measurable, realistic, and achievable goal for the solution of occupations involving performance problems.

Second stage: Develop and evaluate the pros and cons of possible solutions by brainstorming through the occupation determined with the COPM.

Third stage: After deciding on a possible solution, making a plan and taking action:

  • Adaptation of the occupation determined with the COPM, making alterations to one or more of the following: who (involving another person), where (making a change in the place), when (changing the time), how (altering the way of application) and what (adding up new steps at the beginning or end of the occupation).
  • Planning the steps of the occupation (in accordance with priority),
  • Bringing together occupation-related information and resources

Fourth stage: Revising the therapy process which has been activated with the CC training

Fifth stage: Receiving feedback about individual's experiences and making alterations to the course of action when necessary.

Statistical analysis Data were analyzed with SPSS version 25.0 statistical software. Data were presented as mean ± standard deviation values. The conformity of the data to normal distribution was analyzed using the Kolmogorov-Smirnov test. The data were seen not to be distributed normally, so non-parametric statistical methods were used. Differences between groups were analyzed with the Chi-square test for nominal data. Comparisons between the groups were made using the Mann-Whitney U test. Pre- to post-intervention changes within the groups were analyzed with the Wilcoxon signed-rank test. Quade's rank analysis of covariance test was used to compare between group analysis. Statistical significance was evaluated at levels of 0.05.

The power of the study and effect sizes were analyzed using G*Power software, version 3.1.9.2. Power analysis was performed to calculate the sample size. It was determined that 21 subjects were needed in each group to ensure a power of 90%, assuming a two-tailed test for α equal to 0.05. Effect size was calculated using the means and standard deviations of the groups. Effect size benchmarks were determined as <0.30, 0.30-0.80, and >0.80, interpreted as small, moderate, and strong, respectively.

Conditions
Arthritis Knee
Being tested
Client-centered
Keywords
Client-centered, Quality of life, Knee arthroplasty, Occupational performance, Telerehabilitation, Telemedicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Client-centeredOther

    Rehabilitation

Study groups in NCT04969432
Study groupRoleWhat they receive
TelerehabilitationExperimentalNot described
Receives: Other: Client-centered
Face-to-faceExperimentalNot described
Receives: Other: Client-centered

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Canadian Occupational Performance Measure

    Measured: 40 minutes

  2. Nottingham Health Profile

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start7 Jan 2021
  3. Primary completion30 May 2021
  4. Study completion30 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04969432
Sponsor's protocol ID
Saglik Bilimleri Universitesi
Status last verified
Jul 2021
First submitted
8 Jul 2021
Last updated
20 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40336669

Questions about this trial

What is this clinical trial studying?

A study testing Client-centered in people with Arthritis Knee, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969432, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.

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