NCT06080360

Brief Summary

Objective: To verify the reliability and validity of the Turkish versions of the Hopkins Rehabilitation Engagement Rating Scale (HRERS) for knee arthroplasty. Methods: A total of 51 consecutive participants, inpatients of an orthopedic clinic at the university hospital, were recruited between 2021-2022 June. Cronbach's alpha coefficient was used to assess internal consistency. By evaluating the scores of 51 retested patients one week later, the test-retest reliability was determined using the intraclass correlation coefficient (ICC). Pearson's correlation coefficient was used to assess the construct validity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

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

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
Last Updated

October 13, 2023

Status Verified

October 1, 2023

Enrollment Period

1 year

First QC Date

October 2, 2023

Last Update Submit

October 11, 2023

Conditions

Keywords

Rehabilitation EngagementPatient-Reported Outcome MeasuresTotal Knee ArthroplastyHopkins Rehabilitation Engagement Rating ScaleTurkish Version

Outcome Measures

Primary Outcomes (1)

  • Hopkins Rehabilitation Engagement Rating Scale-HRERS

    HRERS is a 5-item and practitioner completed scale used to rate behavioral observations of patients during acute inpatient rehabilitation.To evaluate the parameters of engagement in rehabilitation activities, the HRERS items rate the following: (I) the level of attendance at therapy sessions, (II) the attitude expressed by the patient toward his/her therapy, (III) the need for verbal or physical prompts to facilitate initiation or maintenance of engagement within the therapy session, (IV) the patient's acknowledgment of the need for therapy and (V) the patient's level of active participation in the therapy. This questionnaire evaluates five items on a 6-level-likert scale from 1 (never) to 6 (always). Higher scores indicate higher engagement levels.

    3-5 days (after every rehabilitatiom program)

Secondary Outcomes (3)

  • Functional Independence Measurement-FIM

    3-5 days (after every rehabilitatiom program)

  • Barthel Index

    3-5 days (after every rehabilitatiom program)

  • European Quality of Life-5 Dimensions Questionnaire-EQ-5D

    3-5 days (after every rehabilitatiom program)

Interventions

Functional Independence Measurement-FIM, Barthel Index and European Quality of Life-5 Dimensions Questionnaire-EQ-5D, which are self-report based evaluation methods, were applied to patients who received routine treatment and met the inclusion criteria.To determine the patients' level of participation in the treatment, Hopkins was scored by the physiotherapist applying the treatment.

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The required sample size for validation studies was reported as 2-20 participants per item on the scale (14). HRERS consists of five questions, thus we included at least fifty participants. A total of 51 consecutive participants, inpatients of an orthopaedic clinic at university hospital, were recruited between 2021-2022 June.

You may qualify if:

  • Providing hospitalization and rehabilitation follow-up due to knee or hip arthroplasty by Süleyman Demirel University Hospital, Department of Orthopedics and Traumatology,
  • Volunteering to participate in the study,
  • It means getting a score of 24 or above when the Standardized Mini Mental Test Score is applied.

You may not qualify if:

  • Having serious vision and hearing loss,
  • Having an orthopedic, vestibular, neurological or mental problem such as upper and lower extremity pathology that may prevent or limit the application of the test protocol,
  • Having a diagnosis of postural hypotension,
  • Lack of cooperation,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menekşe ŞAFAK

Merkez, Isparta, 32000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Patient Reported Outcome Measures

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Zeliha BAŞKURT, Prof. Dr.

    Suleyman Demirel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Res. Assist.

Study Record Dates

First Submitted

October 2, 2023

First Posted

October 12, 2023

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

March 1, 2023

Last Updated

October 13, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations