German translation and cultural adaptation of the Patient Reported Impact of Spasticity Measure (PRISM) to measure the impact of spasticity after spinal cord injury on quality of life.
| ISRCTN | ISRCTN16205256 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16205256 |
| Secondary identifying numbers | LA 41 |
- Submission date
- 28/10/2023
- Registration date
- 29/11/2023
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Spasticity is a common issue in 60-80% of people with spinal cord injuries. It can be a big challenge, affecting daily activities. Interestingly, some patients find spasticity helpful for tasks like maintaining balance during transfers.
To understand how spasticity affects the quality of life, we use patient-reported outcome measures (PROMs). These help us evaluate the impact and effectiveness of treatments. An expert group recommends two PROMs for measuring quality of life in people with spasticity after a spinal cord injury: the Patient Reported Impact of Spasticity Measure (PRISM) and the Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET). These tools have been carefully chosen and are backed by solid research.
SCI-SET has been translated into German. The PRISM is in the process of being translated. What's great about the PRISM is that it can be used not only for spinal cord injuries but also for other conditions like multiple sclerosis.
The PRISM is easy to use, takes about 10 minutes, and is free. We need it in German to understand how spasticity affects patients' lives and evaluate treatments better. We follow international guidelines for the translation and cultural adaptation. This study aims to make sure the German version is clear and reliable, with input from patients. This version will help assess spasticity interventions and their effects in daily life for German-speaking individuals.
Who can participate?
Patients with spinal cord injuries in the AUVA rehabilitation centers Weißer Hof and Tobelbad (Austria)
What does the study involve?
The translation process includes a personal comprehensibility test. The patients receive the pre-final version in printed form and fill it out. In the course of a semi-structured interview, they are asked about comprehensibility in order to find out which terms might be problematic. The distribution of the answers is examined for missing items.
What are the possible benefits and risks of participating?
It is not expected that the study participants will derive any personal health benefit from their participation, but they can contribute to the further development of a standardized measurement procedure and further on to the improvement of the quality of care. After completion of the German version of the PRISM, the patients' view of the impact of spasticity on quality of life can also be recorded in German-speaking countries. This will allow to better investigate the effectiveness of interventions and to adapt the selection of interventions for spasticity reduction. Subsequent patients with the same disease will benefit in terms of goal-oriented physiotherapeutic treatment.
No risks for the study participants are to be expected. However, it must be taken into account that the content of the questionnaire confronts the study participants with the limitations in daily life due to the spinal cord injury.
Where is the study run from?
Danube University Krems (Austria)
When is the study starting and how long is it expected to run for?
May 2023 to August 2024
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Anja Largler, anja.largler@gmail.com
Contact information
Public, Scientific, Principal Investigator
Parkring 16
Leopoldsdorf
2333
Austria
| Phone | +43 6765126792 |
|---|---|
| anja.largler@gmail.com |
Study information
| Study design | Multicenter qualitative study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Qualitative study |
| Study setting(s) | Other |
| Study type | Quality of life, Screening |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Semi-structured interviews with patients with spinal cord injury to test the comprehensibility of the PRISM questionnaire. |
| Study objectives | The aim of this study is to provide an authorized, German-language version of the PATIENT REPORTED IMPACT OF SPASTICITY MEASURE (PRISM). |
| Ethics approval(s) |
1. Approved 10/01/2024, Ethics commitee for the hospitals of the AUVA (Wienerbergstraße 11, Wien, 1100, Austria; +43 59320805; ethikkommission@auva.at), ref: 03/2024 2. Approved 12/12/2023, Ethics Commission of the province of Lower Austria (Landhausplatz 1, Haus 15B, St. Pölten, 3109, Austria; +43 2742900513367; post.ethikkommission@noel.gv.at), ref: GS1-EK-4/880-2023 |
| Health condition(s) or problem(s) studied | Measuring the impact of spasticity after spinal cord Injury on quality of life. |
| Intervention | After obtaining informed consent, the pre-final version of the PRISM questionnaire in German is presented to the patients for completion and a semi-structured interview is conducted to assess the comprehensibility of the questionnaire items. The distribution of responses will be examined for missing items. The study participants will incur a one-time additional time expenditure of approximately 1 hour as a result of the measure. |
| Intervention type | Other |
| Primary outcome measure | Qualitative semi-structured interviews to test the comprehensibility of the translated version of the "Patient reported impact of spasticity measure" for measuring the impact of spasticity after spinal cord injury on quality of life. Qualitative analysis of the interviews: Content analysis according to Mayring |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 18/05/2023 |
| Completion date | 31/08/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | 1. Patients with clinically confirmed spinal cord injury of traumatic, nontraumatic, or congenital origin. 2. Patients from 3 months after the spinal cord lesion onwards. 3. Patients with existing spasticity symptoms 4. Age ≥ 18 years 5. Good knowledge of written and spoken German 6. Signed voluntary informed consent for study participation |
| Key exclusion criteria | Decreased cognitive and language abilities |
| Date of first enrolment | 01/03/2024 |
| Date of final enrolment | 31/08/2024 |
Locations
Countries of recruitment
- Austria
Study participating centres
Klosterneuburg
3400
Austria
8144
8144
Austria
Sponsor information
Other
Dr.-Karl-Dorrek-Straße 30
Krems an der Donau
3500
Austria
| Phone | +43 2732 893 6000 |
|---|---|
| info@donau-uni.ac.at | |
| Website | https://www.donau-uni.ac.at |
"ROR" |
https://ror.org/03ef4a036 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Anja Largler, anja.largler@gmail.com |
Editorial Notes
16/02/2024: The ethics approval was added.
29/11/2023: Trial's existence confirmed by NÖ Ethikkommission
