Lower extremity outcome measures: considerations for clinical trials in spinal cord injury.
Spinal Cord
; 56(7): 628-642, 2018 07.
Article
en En
| MEDLINE
| ID: mdl-29700477
ABSTRACT
STUDY DESIGN:
This is a focused review article.OBJECTIVES:
To identify important concepts in lower extremity (LE) assessment with a focus on locomotor outcomes and provide guidance on how existing outcome measurement tools may be best used to assess experimental therapies in spinal cord injury (SCI). The emphasis lies on LE outcomes in individuals with complete and incomplete SCI in Phase II-III trials.METHODS:
This review includes a summary of topics discussed during a workshop focusing on LE function in SCI, conceptual discussion of corresponding outcome measures and additional focused literature review.RESULTS:
There are a number of sensitive, accurate, and responsive outcome tools measuring both quantitative and qualitative aspects of LE function. However, in trials with individuals with very acute injuries, a baseline assessment of the primary (or secondary) LE outcome measure is often not feasible.CONCLUSION:
There is no single outcome measure to assess all individuals with SCI that can be used to monitor changes in LE function regardless of severity and level of injury. Surrogate markers have to be used to assess LE function in individuals with severe SCI. However, it is generally agreed that a direct measurement of the performance for an appropriate functional activity supersedes any surrogate marker. LE assessments have to be refined so they can be used across all time points after SCI, regardless of the level or severity of spinal injury. SPONSORS Craig H. Neilsen Foundation, Spinal Cord Outcomes Partnership Endeavor.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Traumatismos de la Médula Espinal
/
Ensayos Clínicos como Asunto
/
Evaluación de Resultado en la Atención de Salud
/
Extremidad Inferior
Tipo de estudio:
Guideline
/
Qualitative_research
Límite:
Humans
Idioma:
En
Revista:
Spinal Cord
Asunto de la revista:
NEUROLOGIA
Año:
2018
Tipo del documento:
Article
País de afiliación:
Suiza