"Validated Language Transfer of the Spinal Cord Injury-Spasticity Evaluation Tool to German Language"

NCT05022095 | Completed DMC

• 1 other identifier: 2021-05
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

SCI - Spinal Cord Injury; Spastic

Keywords

Spasticity; Spinal Cord Injury; Activities of daily living; Quality of Life

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Asking a question

  Two weeks, initial time point and one week later secondary time point

Study Arms (1)

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.

Other: Questionnaires

Interventions

Questionnaires OTHER

Diverse questionnaires have to be filled in.

SCI Patients with ongoing spasticity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Already done in Group description

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead

Study Sites (1)

Swiss Paraplegic Centre; Centre for pain medicine

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscle Spasticity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Interventional/Conservative pain medicine

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 26, 2021
• Study Start: August 30, 2021
• Primary Completion: January 23, 2023
• Study Completion: January 23, 2023
• Last Updated: March 14, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)