SCI - Spinal Cord Injury Clinical Trial
— SCI-SETdeOfficial title:
"Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"
NCT number | NCT05022095 |
Other study ID # | 2021-05 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 30, 2021 |
Est. completion date | January 23, 2023 |
Verified date | March 2023 |
Source | Swiss Paraplegic Centre Nottwil |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | January 23, 2023 |
Est. primary completion date | January 23, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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) Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Switzerland | Swiss Paraplegic Centre; Centre for pain medicine | Nottwil | Lucerne |
Lead Sponsor | Collaborator |
---|---|
Swiss Paraplegic Centre Nottwil |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Two weeks, initial time point and one week later secondary time point | |
Primary | 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. |
One day, initial time point | |
Primary | 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. |
One day, initial time point | |
Primary | 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). | One day, initial time point | |
Primary | 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). | One day, initial time point | |
Secondary | 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." |
Two weeks, initial time point and one week later secondary time point |
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