Investigation of the reliability and accuracy of the 12-item Multiple Sclerosis Walking Scale (12-WS) in individuals with spinal cord injury
Descrizione riassuntiva dello studio
Individuals with spinal cord injury often suffer from impaired walking function. In rehabilitation, walking function is assessed using various objective gait tests. Currently, there is no questionnaire that asks about the perceived restriction of walking ability from the patient's perspective. Therefore, this study aims to clarify how reliable and accurate the "12-item Multiple Sclerosis Walking Scale" questionnaire can assess these restrictions in individuals with incomplete spinal cord injury. This test has already been tested for accuracy and reliability in individuals with multiple sclerosis and is regularly used in therapy. This study is a multicenter study. This means that data from a total of 67 participants will be collected and subsequently analyzed at the University Hospital Balgrist and the Swiss Paraplegic Centre in Nottwil. Participants help establish the "12-item Multiple Sclerosis Walking Scale" questionnaire for individuals with incomplete spinal cord injuries and thus assess the restrictions of walking ability from the patients' perspective.
(BASEC)
Intervento studiato
During a single study visit, participants will be screened for eligibility and, after inclusion in the study, physically examined by a study physician. Participants will complete the "12-item Multiple Sclerosis Walking Scale" questionnaire and undergo the following clinical gait tests: 10-meter walk test, Timed up and Go test, 6-minute walk test, and Functional Gait Assessment. Additionally, scales for assessing mobility in daily life will be filled out by trained study personnel. After the first measurement day, the "12-item Multiple Sclerosis Walking Scale" questionnaire will be sent to participants by mail, and they will be asked to complete the questionnaire a second time, i.e., 1-8 weeks after the first study visit. Participants will be asked to return the questionnaire in a self-addressed stamped envelope. After receiving the "12-item Multiple Sclerosis Walking Scale" questionnaire, participants will be contacted by phone to inquire if there have been any changes regarding mobility.
(BASEC)
Malattie studiate
Incomplete spinal cord injury
(BASEC)
- Aged between 18 and 80 years - Diagnosis of chronic spinal cord injury (> 6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12 - Walking function must be impaired according to neurological examination (BASEC)
Criteri di esclusione
- Women who are pregnant - Current orthopedic problems of the lower limbs - History of severe heart disease (e.g., infarction, insufficiency (NYHA II-IV)) - History of severe lung disease (e.g., chronic obstructive pulmonary disease GOLD II-IV) - Current severe depression or psychosis - Participation in another interventional study that may affect walking function (BASEC)
Luogo dello studio
Zurigo, Altro
(BASEC)
Nottwil
(BASEC)
Sponsor
PD Dr. Björn Zörner
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
PD Dr. med. Dr. sc. nat. Björn Zörner
+41 44 386 11 11
bjoern.zoerner@clutterbalgrist.chBalgrist University Hospital, Zurich
(BASEC)
Informazioni generali
University of Zurich,
+41 44 510 72 17
bjoern.zoerner@clutterbalgrist.ch(ICTRP)
Informazioni generali
University of Zurich
(ICTRP)
Informazioni scientifiche
University of Zurich,
+41 44 510 72 17
bjoern.zoerner@clutterbalgrist.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
27.02.2024
(BASEC)
ID di studio ICTRP
NCT06256159 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with spinal cord injury (BASEC)
Titolo accademico
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury (ICTRP)
Titolo pubblico
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury (ICTRP)
Malattie studiate
Spinal Cord InjuriesGait Disorders, Neurologic (ICTRP)
Intervento studiato
Other: 12 MSWS questionnaire (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
- Age 18-80 years
- Diagnosis of chronic spinal cord injury (>6 months cervical or thoracic motor
incomplete traumatic or non-traumatic (AIS C, D) above T12
- Must have impaired walking function as demonstrated by neurological examination.
Exclusion Criteria:
- Women who are pregnant or breast feeding
- Current orthopaedic problems of lower limbs
- History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- History of major pulmonary condition (e.g., chronic obstructive pulmonary disease
GOLD II-IV
- Current major depression or psychosis
- Participation in another interventional study (except specTra-study) that may have
an impact on walking function. (ICTRP)
non disponibile
Endpoint primari e secondari
Re-test reliability of the subjective perceived limitations in ambulation of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.;Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI. (ICTRP)
Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury;Walking impairment (numeric value from 0-20) - WISCI II;Walking distance (m) and number of rests - 6MWT;Walking speed (m/s) - 10-meter walkint test (10MWT);Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG);Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17;Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA);Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Swiss National Science Foundation;Swiss Paraplegic Research, Nottwil (ICTRP)
Contatti aggiuntivi
Bj?rn Z?rner, PD Dr.;Sabrina Imhof, PhD, sabrina.imhof@balgrist.ch, +41 44 510 72 17, University of Zurich, (ICTRP)
ID secondari
2023-02304 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06256159 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile