Clinical trial NCT04266964: Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients
Official title: Muscle Excitability Scale for Assessment of Spastic Reflexes in Spinal Cord Injury. Part II: Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spasticity, Muscle
Spinal Cord Injuries
Keywords: Spasticity
Spinal cord injury
Validity
Reliability
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2020-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Spasticity in spinal cord injury

Brief summary: The aim of the study is to verify validity and reliability of the Muscle excitability scale (MES), which has been developed to access muscle susceptibility to spasms and/or clones as part of spastic motor behavior in spinal cord injured patients.

Detailed description: The muscle excitability scale (MES) is intended for patients after spinal cord injury. The objective is to evaluate a motor response (muscle spasms or clones) to a sensory or motor stimulus. A sensory stimulus is created by thumb and pointfinger compression of cutaneous tissue on the inside part of the middle thigh and calf. A motor stimulus is created by passive movement of the lower limb to flexion and extension. The MES grades from 0 to 4 reflect the muscle spastic or clonic tendency and the extent of this motor response (from isolated to generalized). Two investigators will examine a spastic motor behavior in 50 chronic SCI subjects using MES, Modificated Ashworth Scale (MAS) and Penn Spasms Frequency Scale (PSFS) to verify the validity and reliability of the MES.

Eligibility criteria: Inclusion Criteria:

* Spasticity in Spinal Cord Injury

Exclusion Criteria:

* Parallel brain injury
* Cognitive deficit affecting cooperation
* Acute infection or other sudden complication
* Recent change of antispastic medication

Primary outcomes:
measure: Muscle Excitability Scale
timeFrame: through study completion, an average of 1 year
measure: Modified Ashworth Scale
timeFrame: through study completion, an average of 1 year
measure: Penn Spasm Frequency Scale
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Calculation of validity and reliability index of Muscle Excitability Scale
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Department of Rehabilitation and Sports Medicine, University Hospital Motol
city: Prague
country: Czechia
facility: Paraple Center - rehab center for SCI people
Study officials:
affiliation: Spinal Cord Unit, University Hospital, Motol
name: Jiri Kriz, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kriz J, Hlinkova Z. Muscle excitability scale - a novel tool for evaluation of spastic motor behaviors in spinal cord injury patients. In: Proceedings from the 55th ISCoS Annual Scientific Meeting; September 14-16, 2016; Vienna, Austria. Abstract 186.