SCI - Spinal Cord InjurySCI-SETdeNCT05022095
"Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
An observational study of SCI - Spinal Cord Injury and Spastic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
To better depict the full range of spasticity after Spinal Cord Injury (SCI) there is a need to take into account the patients perspective and their experiences during daily life. In 2007 the Spinal Cord Injury-Spasticity Evaluation Tool (SCI-SET) was created and validated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SCI - Spinal Cord Injury, Spastic
- What is being tested?
- Questionnaires
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Aug 2021to 23 Jan 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Already done in Group description
Who may be able to join
- SCI for at least six month and presented with spasticity symptoms
- at least 18 years old
- able to understand the instructions as well as the questionnaires
- no expected changes in medical treatment for the duration of the study (~1 month)
Who cannot join
- inability to provide informed consent
- co-morbidities (e.g. decubitus ulcers, heterotopic ossification, urinary tract infections or other infections) or any psychological state that influences spasticity
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre; Centre for pain medicine
Nottwil, Canton of Lucerne, 6207
About this study
To better depict the full range of spasticity after Spinal Cord Injury (SCI) there is a need to take into account the patients perspective and their experiences during daily life. In 2007 the Spinal Cord Injury-Spasticity Evaluation Tool (SCI-SET) was created and validated. This specific questionnaire addresses the influence of spasticity on the daily life of SCI patients and takes into account negative as well as positive effects of spasticity to fulfill certain tasks. Until now this questionnaire is only available in english, turkish and persian language. Therefore, the investigators translated and culturally adapted this questionnaire and within this study this questionnaire shall be validated in a small cohort of SCI patients. The patients will fill in several different questionnaires at a first meeting and one week later the SCI-SETde questionnaire again to evaluate test-retest properties. Recruiting will happen completely at the Swiss Paraplegic Centre Nottwil, Switzerland.
Read the detailed description
Life expectancy of persons in the acute phase after a spinal cord injury (SCI) dramatically increased in the second half of the last century. The long-term mortality (more than two years post-injury) is still an issue and a strong contributing risk factor are secondary health conditions also including spasticity. Spasticity has been reported to be present in 74% of people in a recent cross-sectional study investigating a cohort including Swiss residents. There are many different forms of spasticity seen in patients as well as varying definitions found in the literature. Furthermore it is recognized that spasticity may have both negative as well as positive impacts on daily life.
Spasticity should not solely be assessed with objective measures and the inclusion of the patient's perspective and personal perception is crucial to completely address and trace out spasticity in each individual. The patient reported impact of spasticity measure (PRISM) as well as the spinal cord injury spasticity evaluation tool (SCI-SET), both established in 2007, are validated and recommended to apply in routine practice. Unfortunately, the SCI-SET is only available in English, Persian and Turkish which hinders the implementation in other language regions.
Therefore the investigators decided to translate and cross-culturally adapt the SCI-SET and create a German version of that questionnaire (SCI-SETde). This finally helps to assess the usefulness of therapeutic interventions and to monitor the course of spasticity in patients. The SCI-SETde will be checked for comprehensibility and tested for cultural aspects in advance to its validation. These are prerequisites that it can later be used in daily routine.
The expected risk and burden for participants is very small because they only have to fill in questionnaires.
The primary objective is to establish the SCI-SETde and to cross-culturally adapt and validate it in a small cohort of patients. The translation and back-translation already happened and the authors of the initial SCI-SET are informed and gave their consent that a German version of this questionnaire may be established.
It is very important that the questionnaire is understandable and well-suited to ask patients about the influence of their spasticity on several areas of daily life. It is necessary to receive feedback on how patients understand each single question and also if any questions are somehow unclear or not enough accurate or specific. To test the validity and reliability of the questionnaire is necessary to evidence its usefulness for assessment.
Test-retest reliability will be assessed by administering the questionnaires two times at the same day and time one week apart. Construct validity will be assessed by comparing the SCI-SETde with scores from additional questionnaires namely, an adapted form of the Penn Spasm Frequency Scale (PSFS) and the self-reported version of the Spinal Cord Independence Measure (SCIM-SR) as well as self-reported impact and severity of spasticity.
There are possible confounders that may interfere with the results. These confounding factors will be assessed on both time points through an additional checklist that asks patients if they suffered from any kind of fracture, decubitus ulcer, any sort of infection, new arisen pain due to any condition as well as any psychogenic trauma.
People within the SCI community of Switzerland will be taken into consideration to participate in this study. The recruitment of the participants will be either a consecutive ongoing recruitment during daily clinical practice or direct contacting of known SCI patients with stated spasticity symptoms. Patients will be informed in detail about the project if they meet all the inclusion criteria and no exclusion criteria is found in routine practice. Participants are not receiving any compensation for their participation in the study. For each patient the project duration is roughly two weeks.
All the data will be stored safely with only authorized people having access to the data corresponding to their duties to manage or analyze the data. The physical data will be entered into the secure databank for final analysis. All data is encoded by giving each participant a unique patient ID that doesn't allow any inference on the identity of the person. The key document with the link between the patient ID and the person behind it will be stored in a secured desk separately from the remaining study documents.
- Conditions
- SCI - Spinal Cord Injury, Spastic
- Being tested
- Questionnaires
- Keywords
- Spasticity, Spinal Cord Injury, Activities of daily living, Quality of Life
- Medical subject headings
- Spinal Cord Injuries, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Diverse questionnaires have to be filled in.
| Study group | Role | What they receive |
|---|---|---|
| SCI Patients with ongoing spasticity | SCI Patients that are either seen in clinical routine due to fillings or controls of their intrathecal injection pumps or stationary patients will be informed about the project, they are granted with enough time to decide whether they want participate or not. After giving Informed Consent they will be administered a set of questionnaires including SCI-SETde, PSFS (adapted to german), SCIM-SR in german as well as self-evaluation of spasticity severity and intensity. The SCI-SETde will be filled in again one week later to evaluate test-retest reliability. Overall, the burden for the patients is kept at minimum. There are no expected risks or harm to the patients. Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of the Spinal Cord Injury - Spasticity Evaluation Tool german version (SCI-SETde)
The score is divided into a negative and a positive subscore as well as a given total overall score resulting from the 35 items which can be rated in the range from (-3) "extremely problematic" to +3 "extremely helpful". So the lowest (negative) achievable score is -105 and indicates a high limitation due to spasticity to execute activities of daily living. The highest achievable score is 105 and indicates a high supporting function of spasticity to execute activities of daily living.
Measured: Two weeks, initial time point and one week later secondary time point
Score from the adapted Penn Spasm Frequency Scale (PSFS)
Frequency score: ranging from 0 "no spasms at all" to 4 "spasms occur more than ten times per hour".
The score is descriptive indicating the frequency of spasms. The meaning of the score for the outcome remains open because it depends on several factors. If the spasms are beneficiary for example to transfer from wheelchair to car or bed we have to keep in mind that the patient doesn't need to transfer more than ten times per hour. But it might be helpful if the spasms occur several times per hour.
Intensity score: ranging from 1 "weak" to 3 "strong". The score is descriptive indicating the intensity of spasms. The outcome depends on whether the spasms are limiting or helpful for the patient and depending on whether a strong spasm is more helpful than a moderate spasm. It may be that a strong spasm is limiting whereas a moderate spasm is helpful. So there is no general statement possible and the score can only be interpreted by taking all factors into consideration.
Measured: One day, initial time point
Score from Spinal Cord Independence Measure version 3 self-reported (SCIM III - SR)
The total score of the SCIM III - self reported questionnaire consisting of 19 items.
Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Measured: One day, initial time point
Self-evaluation of severity grade of spasticity
The participants are asked to rate the severity grade of their spasticity on a scale ranging from 0 (no spasticity) to 5 (highest imaginable grade of spasticity).
Measured: One day, initial time point
Self-evaluation of limitation in daily life due to spasticity
The participants are asked to rate the extent of limitation in daily life due to their spasticity on a scale ranging from 0 (no limitation) to 5 (highest imaginable limitation).
Measured: One day, initial time point
Secondary outcomes (1)
Asking a question
"Were there any questions that are unclear or undetermined?"
Response format: Yes/No. "If yes, please indicate which question it concerns and make a suggestion how to write the question."
Measured: Two weeks, initial time point and one week later secondary time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start30 Aug 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Tim Reck, Swiss Paraplegic Research, Nottwil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022095
- Sponsor's protocol ID
- 2021-05
- Acronym
- SCI-SETde
- Status last verified
- Mar 2023
- First submitted
- 16 Aug 2021
- Last updated
- 14 Mar 2023
- 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 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
- ClinicalTrials.gov ID
- NCT05022095
- Acronym / sponsor ID
- SCI-SETde / 2021-05
- Conditions
- SCI - Spinal Cord Injury, Spastic
- Keywords
- Spasticity, Spinal Cord Injury, Activities of daily living, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 26 Aug 2021 (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.
To better depict the full range of spasticity after Spinal Cord Injury (SCI) there is a need to take into account the patients perspective and their experiences during daily life. In 2007 the Spinal Cord Injury-Spasticity Evaluation Tool (SCI-SET) was created and validated. This specific questionnaire addresses the influence of spasticity on the daily life of SCI patients and takes into account negative as well as positive effects of spasticity to fulfill certain tasks. Until now this questionnaire is only available in english, turkish and persian language. Therefore, the investigators translated and culturally adapted this questionnaire and within this study this questionnaire shall be validated in a small cohort of SCI patients. The patients will fill in several different questionnaires at a first meeting and one week later the SCI-SETde questionnaire again to evaluate test-retest properties. Recruiting will happen completely at the Swiss Paraplegic Centre Nottwil, Switzerland.
Detailed description
Life expectancy of persons in the acute phase after a spinal cord injury (SCI) dramatically increased in the second half of the last century. The long-term mortality (more than two years post-injury) is still an issue and a strong contributing risk factor are secondary health conditions also including spasticity. Spasticity has been reported to be present in 74% of people in a recent cross-sectional study investigating a cohort including Swiss residents. There are many different forms of spasticity seen in patients as well as varying definitions found in the literature. Furthermore it is recognized that spasticity may have both negative as well as positive impacts on daily life.
Spasticity should not solely be assessed with objective measures and the inclusion of the patient's perspective and personal perception is crucial to completely address and trace out spasticity in each individual. The patient reported impact of spasticity measure (PRISM) as well as the spinal cord injury spasticity evaluation tool (SCI-SET), both established in 2007, are validated and recommended to apply in routine practice. Unfortunately, the SCI-SET is only available in English, Persian and Turkish which hinders the implementation in other language regions.
Therefore the investigators decided to translate and cross-culturally adapt the SCI-SET and create a German version of that questionnaire (SCI-SETde). This finally helps to assess the usefulness of therapeutic interventions and to monitor the course of spasticity in patients. The SCI-SETde will be checked for comprehensibility and tested for cultural aspects in advance to its validation. These are prerequisites that it can later be used in daily routine.
The expected risk and burden for participants is very small because they only have to fill in questionnaires.
The primary objective is to establish the SCI-SETde and to cross-culturally adapt and validate it in a small cohort of patients. The translation and back-translation already happened and the authors of the initial SCI-SET are informed and gave their consent that a German version of this questionnaire may be established.
It is very important that the questionnaire is understandable and well-suited to ask patients about the influence of their spasticity on several areas of daily life. It is necessary to receive feedback on how patients understand each single question and also if any questions are somehow unclear or not enough accurate or specific. To test the validity and reliability of the questionnaire is necessary to evidence its usefulness for assessment.
Test-retest reliability will be assessed by administering the questionnaires two times at the same day and time one week apart. Construct validity will be assessed by comparing the SCI-SETde with scores from additional questionnaires namely, an adapted form of the Penn Spasm Frequency Scale (PSFS) and the self-reported version of the Spinal Cord Independence Measure (SCIM-SR) as well as self-reported impact and severity of spasticity.
There are possible confounders that may interfere with the results. These confounding factors will be assessed on both time points through an additional checklist that asks patients if they suffered from any kind of fracture, decubitus ulcer, any sort of infection, new arisen pain due to any condition as well as any psychogenic trauma.
People within the SCI community of Switzerland will be taken into consideration to participate in this study. The recruitment of the participants will be either a consecutive ongoing recruitment during daily clinical practice or direct contacting of known SCI patients with stated spasticity symptoms. Patients will be informed in detail about the project if they meet all the inclusion criteria and no exclusion criteria is found in routine practice. Participants are not receiving any compensation for their participation in the study. For each patient the project duration is roughly two weeks.
All the data will be stored safely with only authorized people having access to the data corresponding to their duties to manage or analyze the data. The physical data will be entered into the secure databank for final analysis. All data is encoded by giving each participant a unique patient ID that doesn't allow any inference on the identity of the person. The key document with the link between the patient ID and the person behind it will be stored in a secured desk separately from the remaining study documents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI Patients with ongoing spasticity | – | Other: QuestionnairesSCI Patients that are either seen in clinical routine due to fillings or controls of their intrathecal injection pumps or stationary patients will be informed about the project, they are granted with enough time to decide whether they want participate or not. After giving Informed Consent they will be administered a set of questionnaires including SCI-SETde, PSFS (adapted to german), SCIM-SR in german as well as self-evaluation of spasticity severity and intensity. The SCI-SETde will be filled in again one week later to evaluate test-retest reliability. Overall, the burden for the patients is kept at minimum. There are no expected risks or harm to the patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Already done in Group description
Key inclusion criteria (4 listed)
- SCI for at least six month and presented with spasticity symptoms
- at least 18 years old
- able to understand the instructions as well as the questionnaires
- no expected changes in medical treatment for the duration of the study (~1 month)
Key exclusion criteria (2 listed)
- inability to provide informed consent
- co-morbidities (e.g. decubitus ulcers, heterotopic ossification, urinary tract infections or other infections) or any psychological state that influences spasticity
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 |
|---|---|---|
| QuestionnairesDiverse questionnaires have to be filled in. | Other | SCI Patients with ongoing spasticity |
Primary outcome
Score of the Spinal Cord Injury - Spasticity Evaluation Tool german version (SCI-SETde)
Time frame: Two weeks, initial time point and one week later secondary time point
The score is divided into a negative and a positive subscore as well as a given total overall score resulting from the 35 items which can be rated in the range from (-3) "extremely problematic" to +3 "extremely helpful". So the lowest (negative) achievable score is -105 and indicates a high limitation due to spasticity to execute activities of daily living. The highest achievable score is 105 and indicates a high supporting function of spasticity to execute activities of daily living.
Score from the adapted Penn Spasm Frequency Scale (PSFS)
Time frame: One day, initial time point
Frequency score: ranging from 0 "no spasms at all" to 4 "spasms occur more than ten times per hour". The score is descriptive indicating the frequency of spasms. The meaning of the score for the outcome remains open because it depends on several factors. If the spasms are beneficiary for example to transfer from wheelchair to car or bed we have to keep in mind that the patient doesn't need to transfer more than ten times per hour. But it might be helpful if the spasms occur several times per hour. Intensity score: ranging from 1 "weak" to 3 "strong". The score is descriptive indicating the intensity of spasms. The outcome depends on whether the spasms are limiting or helpful for the patient and depending on whether a strong spasm is more helpful than a moderate spasm. It may be that a strong spasm is limiting whereas a moderate spasm is helpful. So there is no general statement possible and the score can only be interpreted by taking all factors into consideration.
Score from Spinal Cord Independence Measure version 3 self-reported (SCIM III - SR)
Time frame: One day, initial time point
The total score of the SCIM III - self reported questionnaire consisting of 19 items. Self-care subscale, Items 1-4 (0-20); Respiration and sphincter management subscale, Items 5-8 (0-40); Mobility subscale, Items 9-17 (0-40) Scores are higher in patients that require less assistance or fewer aids to complete basic activities of daily living and life support activities.
Self-evaluation of severity grade of spasticity
Time frame: One day, initial time point
The participants are asked to rate the severity grade of their spasticity on a scale ranging from 0 (no spasticity) to 5 (highest imaginable grade of spasticity).
Self-evaluation of limitation in daily life due to spasticity
Time frame: One day, initial time point
The participants are asked to rate the extent of limitation in daily life due to their spasticity on a scale ranging from 0 (no limitation) to 5 (highest imaginable limitation).
1 secondary outcome
Asking a question
Time frame: Two weeks, initial time point and one week later secondary time point
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 14 Mar 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.
The record lists no contact. Use the official record to reach the sponsor.
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 SCI - Spinal Cord Injury and Spastic, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
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 2 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 14 Mar 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 Switzerland. 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?
Score of the Spinal Cord Injury - Spasticity Evaluation Tool german version (SCI-SETde) (time frame: Two weeks, initial time point and one week later secondary time point). The study lists 5 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 14 Mar 2023.