Rehabilitation(HRERS)NCT06080360
The Hopkins Rehabilitation Engagement Rating Scale
An observational study of Rehabilitation, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- Patient-Reported Outcome Measures
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 1 Mar 2023
- Phase
- Observational
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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,
- Being in the recovery period of an acute disease was determined as an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Hopkins Rehabilitation Engagement Rating Scale (HRERS): Cross-cultural Adaptation, Reliability, and Validity of the Turkish Version
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.
Read the detailed description
First of all, permission was obtained from Kortte et al., one of the developers of Hopkins Rehabilitation Engagement Rating Scale (HRERS), to have a Turkish version of HRERS via e-mail before starting the research study. The translation and the cultural adaptation of the Turkish version of the HRERS were accomplished in line with the stages outlined by Beaton et al.. Two independent native Turkish translators performed forward translation. One was a physiotherapist to ensure clinical consistency, and the other was a translator with no medical or clinical background to reveal vague concepts in the original questionnaire. A single consequent Turkish translation was formed from the combination of the two translations The Turkish scale was translated back into English by two English-native speakers who speak Turkish fluently, and the English version of the scale was compared to the original. A group of experts authorized the final version of the document in Turkish, which was backward translation. Translators reviewed the translations and compared certain inconsistencies.
Before the formal questionnaire, the pre-final Turkish version of the questionnaire was used for a pilot test. The Turkish translation was primarily applied to five participants for the detection of unintelligible questions or words. Turkish translation was applied to five participants in order to determine the questions or words that were not understood. We asked the participants the following questions: "Is there a question you don't understand?" "Are there any words you don't like?" Since the participants did not have any problems, no changes were made to the questionnaire, and the final Turkish version of the HRERS (HRERS-T) was provided.
- Conditions
- Rehabilitation
- Being tested
- Patient-Reported Outcome Measures
- Keywords
- Rehabilitation Engagement, Patient-Reported Outcome Measures, Total Knee Arthroplasty, Hopkins Rehabilitation Engagement Rating Scale, Turkish Version
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Reported Outcome MeasuresOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3-5 days (after every rehabilitatiom program)
Secondary outcomes (3)
Functional Independence Measurement-FIM
The FIM instrument is the functional assessment measure. The FIM includes 18 items that measure functional independence in 6 subscales: self-care, sphincter control, mobility, locomotion, communication, and social cognition.Each item is rated on a seven-point scale that represents different gradations of independence and reflects the amount of assistance the patient requires to perform a specific activity. Independence is categorized and scored as complete independence, 7; modified independence, 6; requires supervision or setup, 5; requires minimal contact assistance, 4; requires moderate assistance, 3; requires maximal assistance, 2; and requires total assistance, 1. The sum of all 18 items comprises the patient's total FIM score, which ranges from 18 to 126
Measured: 3-5 days (after every rehabilitatiom program)
Barthel Index
Based on observation, this practitioner-reported index measures patients' functional status across 10 domains: faecal incontinence, urinary incontinence, personal care (cleaning teeth, shaving), using the toilet, feeding, transfers (e.g. chair to bed), walking, dressing, climbing stairs, and bathing (or showering). Scoring of individual domains range between 0 and 15 (at 5-point intervals): domains vary in the number of intervals offered. The total score is used which ranges from 0 (no functioning) to 100 (independent functioning)
Measured: 3-5 days (after every rehabilitatiom program)
European Quality of Life-5 Dimensions Questionnaire-EQ-5D
Quality of life was assessed in hospital using EQ-5D, which consists of two tools: EQ. 5D descriptive system and EQ. 5D-VAS. The EQ. 5D descriptive system is a questionnaire evaluating 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) from which a score ranging from 0 to 1 (maximum health status) is derived. The EQ. 5D-VAS is a visual analogue scale ranging from 0 to 100 (maximum health status) where patients has to indicate the level of health status
Measured: 3-5 days (after every rehabilitatiom program)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menekse Safak, Suleyman Demirel University
- Investigators
- Zeliha BAŞKURT, Prof. Dr., Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080360
- Sponsor's protocol ID
- MS2023/01
- Acronym
- (HRERS)
- Status last verified
- Oct 2023
- First submitted
- 2 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Hopkins Rehabilitation Engagement Rating Scale (HRERS): Cross-cultural Adaptation, Reliability, and Validity of the Turkish Version
- ClinicalTrials.gov ID
- NCT06080360
- Acronym / sponsor ID
- (HRERS) / MS2023/01
- Conditions
- Rehabilitation
- Keywords
- Rehabilitation Engagement, Patient-Reported Outcome Measures, Total Knee Arthroplasty, Hopkins Rehabilitation Engagement Rating Scale, Turkish Version
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
First of all, permission was obtained from Kortte et al., one of the developers of Hopkins Rehabilitation Engagement Rating Scale (HRERS), to have a Turkish version of HRERS via e-mail before starting the research study. The translation and the cultural adaptation of the Turkish version of the HRERS were accomplished in line with the stages outlined by Beaton et al.. Two independent native Turkish translators performed forward translation. One was a physiotherapist to ensure clinical consistency, and the other was a translator with no medical or clinical background to reveal vague concepts in the original questionnaire. A single consequent Turkish translation was formed from the combination of the two translations The Turkish scale was translated back into English by two English-native speakers who speak Turkish fluently, and the English version of the scale was compared to the original. A group of experts authorized the final version of the document in Turkish, which was backward translation. Translators reviewed the translations and compared certain inconsistencies.
Before the formal questionnaire, the pre-final Turkish version of the questionnaire was used for a pilot test. The Turkish translation was primarily applied to five participants for the detection of unintelligible questions or words. Turkish translation was applied to five participants in order to determine the questions or words that were not understood. We asked the participants the following questions: "Is there a question you don't understand?" "Are there any words you don't like?" Since the participants did not have any problems, no changes were made to the questionnaire, and the final Turkish version of the HRERS (HRERS-T) was provided.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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,
- Being in the recovery period of an acute disease was determined as an exclusion criterion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-Reported Outcome MeasuresFunctional 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. | Other | – |
Primary outcome
Hopkins Rehabilitation Engagement Rating Scale-HRERS
Time frame: 3-5 days (after every rehabilitatiom program)
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 secondary outcomes
Functional Independence Measurement-FIM
Time frame: 3-5 days (after every rehabilitatiom program)
Barthel Index
Time frame: 3-5 days (after every rehabilitatiom program)
European Quality of Life-5 Dimensions Questionnaire-EQ-5D
Time frame: 3-5 days (after every rehabilitatiom program)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeliha BAŞKURT, Prof. Dr. principal investigator
Suleyman Demirel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rehabilitation, run by Suleyman Demirel University 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 3 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 13 Oct 2023. 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?
Hopkins Rehabilitation Engagement Rating Scale-HRERS (time frame: 3-5 days (after every rehabilitatiom program)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2023.