Spasticity, MuscleNCT04266964
Validity and Reliability Study of the Muscle Excitability Scale in Spinal Cord Injury Patients
An observational study of Spasticity, Muscle and Spinal Cord Injuries, run by University Hospital, Motol at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spasticity, Muscle, Spinal Cord Injuries
- What is being tested?
- Manual examination
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesCzechia
- Study dates
- 2 Jan 2020to 25 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Spasticity in spinal cord injury
Who may be able to join
- Spasticity in Spinal Cord Injury
Who cannot join
- Parallel brain injury
- Cognitive deficit affecting cooperation
- Acute infection or other sudden complication
- Recent change of antispastic medication
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Department of Rehabilitation and Sports Medicine, University Hospital Motol
Prague, 150 06
Paraple Center - rehab center for SCI people
Prague, 150 06
About this study
Official title: Muscle Excitability Scale for Assessment of Spastic Reflexes in Spinal Cord Injury. Part II: Validity and Reliability Study
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.
Read the 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.
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries
- Being tested
- Manual examination
- Keywords
- Spasticity, Spinal cord injury, Validity, Reliability
- Medical subject headings
- Muscle Spasticity, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual examinationProcedure or surgery
With the patient in a supine position, squeeze the skinfold between your thumb and pointfinger on the inner aspect of the middle third of the thigh and on the inner aspect of the middle third of the calf.
Place your hand under the proximal calf and the heel and move the leg into maximum flexion at the hip and knee joints. After the response, if any, is completed, move the limb back into full extension. Each of these movements lasts for one second.
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle Excitability Scale
Scoring from 0 to 4; 0 = no motor response (muscle spasm or clonus) to a tactile stimulus or passive movement; 4 = generalized motor response to both a tactile stimulus and passive movement
Measured: through study completion, an average of 1 year
Modified Ashworth Scale
Scoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension
Measured: through study completion, an average of 1 year
Penn Spasm Frequency Scale
Scoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Calculation of validity and reliability index of Muscle Excitability Scale
To determine validity, inter-rater and intra-rater reliability of the Muscle Excitability Scale
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start2 Jan 2020
- Primary completion31 Jan 2023
- Study completion25 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Jiri Kriz, MD, PhD, University Hospital, Motol
- Investigators
- Jiri Kriz, MD, PhD, Principal investigator, Spinal Cord Unit, University Hospital, Motol
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04266964
- Sponsor's protocol ID
- SCI_MES_2019
- Status last verified
- Mar 2023
- First submitted
- 5 Feb 2020
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Excitability Scale for Assessment of Spastic Reflexes in Spinal Cord Injury. Part II: Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT04266964
- Acronym / sponsor ID
- SCI_MES_2019
- Conditions
- Spasticity, Muscle, Spinal Cord Injuries
- Keywords
- Spasticity, Spinal cord injury, Validity, Reliability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 25 Feb 2023 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Spasticity in spinal cord injury
Key inclusion criteria (1 listed)
- Spasticity in Spinal Cord Injury
Key exclusion criteria (4 listed)
- Parallel brain injury
- Cognitive deficit affecting cooperation
- Acute infection or other sudden complication
- Recent change of antispastic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual examinationWith the patient in a supine position, squeeze the skinfold between your thumb and pointfinger on the inner aspect of the middle third of the thigh and on the inner aspect of the middle third of the calf. Place your hand under the proximal calf and the heel and move the leg into maximum flexion at the hip and knee joints. After the response, if any, is completed, move the limb back into full extension. Each of these movements lasts for one second. | Procedure or surgery | – |
Primary outcome
Muscle Excitability Scale
Time frame: through study completion, an average of 1 year
Scoring from 0 to 4; 0 = no motor response (muscle spasm or clonus) to a tactile stimulus or passive movement; 4 = generalized motor response to both a tactile stimulus and passive movement
Modified Ashworth Scale
Time frame: through study completion, an average of 1 year
Scoring from 0 to 4; 0 = no increase in muscle tone; 4 = affected part(s) rigid in flexion or extension
Penn Spasm Frequency Scale
Time frame: through study completion, an average of 1 year
Scoring 0 to 4; 0 = no spasms; 4 = spasms occurring more than 10 times per hour
1 secondary outcome
Calculation of validity and reliability index of Muscle Excitability Scale
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- BackgroundKriz 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiri Kriz, MD, PhD principal investigator
Spinal Cord Unit, University Hospital, Motol
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spasticity, Muscle and Spinal Cord Injuries, run by University Hospital, Motol at 2 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Excitability Scale (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04266964, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.