Investigation of the reliability and accuracy of the 12-item Multiple Sclerosis Walking Scale (12-WS) in individuals with spinal cord injury
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- 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)
Lieu de l’étude
Zurich, Autre
(BASEC)
Nottwil
(BASEC)
Sponsor
PD Dr. Björn Zörner
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
PD Dr. med. Dr. sc. nat. Björn Zörner
+41 44 386 11 11
bjoern.zoerner@clutterbalgrist.chBalgrist University Hospital, Zurich
(BASEC)
Informations générales
University of Zurich,
+41 44 510 72 17
bjoern.zoerner@clutterbalgrist.ch(ICTRP)
Informations générales
University of Zurich
(ICTRP)
Informations scientifiques
University of Zurich,
+41 44 510 72 17
bjoern.zoerner@clutterbalgrist.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
27.02.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06256159 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with spinal cord injury (BASEC)
Titre académique
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury (ICTRP)
Titre public
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury (ICTRP)
Maladie en cours d'investigation
Spinal Cord InjuriesGait Disorders, Neurologic (ICTRP)
Intervention étudiée
Other: 12 MSWS questionnaire (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation;Swiss Paraplegic Research, Nottwil (ICTRP)
Contacts supplémentaires
Bj?rn Z?rner, PD Dr.;Sabrina Imhof, PhD, sabrina.imhof@balgrist.ch, +41 44 510 72 17, University of Zurich, (ICTRP)
ID secondaires
2023-02304 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06256159 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible