StrokeNCT05509205
Turkish Adaptation, Validity and Reliability of Pound Satisfaction Scale in Patients With Stroke After Stroke Rehabilitation
An observational study of Stroke, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to adapt the Pound Satisfaction Scale (PSS) to Turkish society in stroke patients and to make its validity and reliability in Turkish. The PSS scale developed by Pound et al evaluates the patient's satisfaction with the received rehabilitation program and services received in stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Turkish Validity and Reliability of The PSS Scale
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2022to 10 Sep 2022
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients who are treating with stroke rehabilitation
Who may be able to join
- To benefit from Physiotherapy and Rehabilitation services,
- Mini mental state examination (MMSE) score> 24
- Patients with stroke
- Native language being Turkish
Who cannot join
- Native language not being Turkish
- Patients with motor sequelae from other diseases and insufficient cognitive or educational level to complete the scale
- Mini mental state examination (MMSE) score < 24
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emel Mete
Istanbul, 34854
EMEL METE, 05376096265, e_emel86@hotmail.com
Zubeyir SARI, Professor
About this study
The aim of this study is to adapt the Pound Satisfaction Scale (PSS) to Turkish society in stroke patients and to make its validity and reliability in Turkish. The PSS scale developed by Pound et al evaluates the patient's satisfaction with the received rehabilitation program and services received in stroke patients. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Read the detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion. The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a preassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of PSS will be able to be modified. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.
- Conditions
- Stroke
- Being tested
- Turkish Validity and Reliability of The PSS Scale
- Keywords
- stroke, patient satisfaction, rehabilitation
- Medical subject headings
- Stroke, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turkish Validity and Reliability of The PSS ScaleOther
This study is about validation of the Pound Satisfaction Scale to Turkish. The level of satisfaction with the rehabilitation service and treatment of 130 stroke patients undergoing stroke rehabilitation will be evaluated with the Pound satisfaction scale.
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke | In this study 130 patients with stroke who are treating with stroke rehabilitation programs, will be included. Receives: Other: Turkish Validity and Reliability of The PSS Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Satisfaction
Personal Satisfaction will be assessed with Pound Satisfaction Scale (PSS). The scale includes three sub-categories: "care and information given to the patient during treatment", "quantity and quality of treatment" and "Information and support provided to the patient and family after discharge". PSS consists of 13 items in total. Each item is scored ranging from 0 to 3 (0: Strongly disagree, 1: Disagree, 2: Agree, 3: Strongly agree). The highest score is 39 points. High scores indicate a high degree of satisfaction.
Measured: baseline
Patient satisfaction
Patient Satisfaction from physiotherapy will be assessed Patient Satisfaction Scale in Physiotherapy (PSSP). PSSP consists of 14 items under four category subheadings of "treatment (5 items), admission (3items), logistics (4items) and global overall satisfaction (2 items)." It is a 5-point Likert type scoring scale (1 = weak, 5 = perfect). Total scores are calculated out of 100. High scores indicate a high degree of satisfaction.
Measured: baseline
Life quality
Life quality will be assessed with SF-36 (short form). SF-36 (short form) is a general quality of life scale that evaluates physical and mental health. It consists of eight sub-dimensions and 36 items: Physical Function, Social Function, Physical Role Difficulty, Emotional Role Difficulty, Mental Health, Vitality (Energy), Pain and General Health. Scores for each subscale are calculated separately. It is scored from 0 to 100. A score of 0 from the scale indicates poor health, and a score of 100 indicates good health.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start2 Mar 2022
- Primary completion30 Aug 2022 (estimated)
- Study completion10 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Mete, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509205
- Sponsor's protocol ID
- Pound Satisfaction Scale
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Adaptation, Validity and Reliability of Pound Satisfaction Scale in Patients With Stroke After Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT05509205
- Acronym / sponsor ID
- Pound Satisfaction Scale
- Conditions
- Stroke
- Keywords
- stroke, patient satisfaction, rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 10 Sep 2022 (estimated)
- First posted
- 22 Aug 2022 (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.
The aim of this study is to adapt the Pound Satisfaction Scale (PSS) to Turkish society in stroke patients and to make its validity and reliability in Turkish. The PSS scale developed by Pound et al evaluates the patient's satisfaction with the received rehabilitation program and services received in stroke patients. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Detailed description
The reliability and validity of the scale will begin with language equivalence and cultural adaptation. The scale will be translated from English to Turkish by two people who are fluent in Turkish and English. A single Turkish translation will be obtained from these two Turkish translations with a common opinion. The scale, which has been translated into Turkish, will be translated into English by two other people who are fluent in Turkish and English. The scale translated into English will be compared with the original. If the developer of the scale approves the translation of the scale, participants will be recruited for the study. In the pre-trial phase, a preassessment will be conducted with 15 participants to test the intelligibility of the scale. Based on the results of the pre-test phase, the final version of PSS will be able to be modified. The PSS scale will be filled in face-to-face with volunteer participants who have received a stroke rehabilitation program and meet the inclusion criteria. 130 participants will be included in the study. In order to assess the concurrent validity of the PSS, the SF-36 (short form) which evaluates the quality of life, and the Patient Satisfaction Scale in Physiotherapy (PSSP) which evaluates patient satisfaction will be used. Scales will be repeated after 15 days to assess test-retest reliability.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke | – | Other: Turkish Validity and Reliability of The PSS ScaleIn this study 130 patients with stroke who are treating with stroke rehabilitation programs, will be included. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients who are treating with stroke rehabilitation
Key inclusion criteria (4 listed)
- To benefit from Physiotherapy and Rehabilitation services,
- Mini mental state examination (MMSE) score> 24
- Patients with stroke
- Native language being Turkish
Key exclusion criteria (3 listed)
- Native language not being Turkish
- Patients with motor sequelae from other diseases and insufficient cognitive or educational level to complete the scale
- Mini mental state examination (MMSE) score < 24
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 |
|---|---|---|
| Turkish Validity and Reliability of The PSS ScaleThis study is about validation of the Pound Satisfaction Scale to Turkish. The level of satisfaction with the rehabilitation service and treatment of 130 stroke patients undergoing stroke rehabilitation will be evaluated with the Pound satisfaction scale. | Other | Patients with stroke |
Primary outcome
Personal Satisfaction
Time frame: baseline
Personal Satisfaction will be assessed with Pound Satisfaction Scale (PSS). The scale includes three sub-categories: "care and information given to the patient during treatment", "quantity and quality of treatment" and "Information and support provided to the patient and family after discharge". PSS consists of 13 items in total. Each item is scored ranging from 0 to 3 (0: Strongly disagree, 1: Disagree, 2: Agree, 3: Strongly agree). The highest score is 39 points. High scores indicate a high degree of satisfaction.
Patient satisfaction
Time frame: baseline
Patient Satisfaction from physiotherapy will be assessed Patient Satisfaction Scale in Physiotherapy (PSSP). PSSP consists of 14 items under four category subheadings of "treatment (5 items), admission (3items), logistics (4items) and global overall satisfaction (2 items)." It is a 5-point Likert type scoring scale (1 = weak, 5 = perfect). Total scores are calculated out of 100. High scores indicate a high degree of satisfaction.
Life quality
Time frame: baseline
Life quality will be assessed with SF-36 (short form). SF-36 (short form) is a general quality of life scale that evaluates physical and mental health. It consists of eight sub-dimensions and 36 items: Physical Function, Social Function, Physical Role Difficulty, Emotional Role Difficulty, Mental Health, Vitality (Energy), Pain and General Health. Scores for each subscale are calculated separately. It is scored from 0 to 100. A score of 0 from the scale indicates poor health, and a score of 100 indicates good health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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.
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 Stroke, run by Istanbul Medeniyet 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Satisfaction (time frame: baseline). The study lists 3 primary outcomes in all. 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 26 Aug 2022.