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Assesment of Post-stroke Elbow Flexor Spasticity in Different Forearm Positions

Assesment of Post-stroke Elbow Flexor Spasticity in Response to Passive Stretch in Different Forearm Positions

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03563209
Enrollment
60
Registered
2018-06-20
Start date
2018-03-15
Completion date
2018-08-15
Last updated
2019-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-stroke Elbow Spasticity

Keywords

Elbow spasticity, Stroke

Brief summary

Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation. In this study, hypothesis is that the severity of spasticity differs depending on the forearm position.

Detailed description

There are three main muscles that contribute to elbow flexor spasticity; musculus biceps brachii, musculus brachialis and musculus brachioradialis. Muscle selection in elbow flexor spasticity for botulinum toxin application has impact on treatment outcome. The superficiality of the biceps brachii muscle makes it an easy target for botulinum toxin injection. In dynamic electromyography studies, it has been reported that brachioradialis muscle is the most common contributor one to elbow flexion spasticity, followed by biceps brachii muscle. In the diagnostic selective nerve blocks, the brachialis muscle has been reported to be foreground. Determination of which muscle is more spastic before injection of the botulinum toxin, and the application of the targeted treatment to that muscle results in more improvement in spasticity. Can the target muscle selection clinically be performed instead of methods such as electromyography where equipment is required and the evaluation period is relatively long? Can semi-quantitative methods used to assess the severity of spasticity provide reliable information regarding the muscle or muscles that contribute to elbow flexor spasticity? It is known that the muscles that flex elbow in healthy individuals change according to forearm position. While the biceps brachii flexes the forearm in supination, the brachioradialis flexes the forearm in the neutral position. The brachialis muscle acts as a primary flexor muscle when the forearm is in pronation. The aim of this study is to investigate whether the severity of spasticity differs depending on the forearm position.

Interventions

None listed

Sponsors

Izmir Katip Celebi University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Elbow flexor spasticity * Grade 1 to 3 spasticity measured with Modified Ashworth Scale * To agree to participate in the study

Exclusion criteria

* \<18 years old * Pregnancy * Botulinum toxin injection within the last three months * Presence of elbow contracture * History of operation to spastic upper extremity * Spasticity due to other causes other than stroke * Do not agree to participate in the study

Design outcomes

Primary

MeasureTime frameDescription
Dynamic Component of Spasticity (Spasticity Angle)1 day (Only one measurement was performed in time (cross-sectional))According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately.

Countries

Turkey (Türkiye)

Participant flow

Recruitment details

This study enrolled patients with post-stroke elbow flexor spasticity from a single medical center in Turkey. The last patients completed in July 2018

Participants by arm

ArmCount
Post-stroke Elbow Flexor Spasticity
Participants with post-stroke elbow flexor spasticity
60
Total60

Baseline characteristics

CharacteristicPost-stroke Elbow Flexor Spasticity
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
18 Participants
Age, Categorical
Between 18 and 65 years
42 Participants
Age, Continuous57.82 years
STANDARD_DEVIATION 12.66
Angle of muscle reaction in pronation110 degree
Angle of muscle reaction in supination120 degree
Angle of muscle reaction in the neutral position115 degree
Brunnstrom stage of motor recovery of hand3 units on a scale
Brunnstrom stage of motor recovery of lower extremity3 units on a scale
Brunnstrom stage of motor recovery of upper extremity3 units on a scale
Disease duration38 months
Quality of muscle reaction in pronation2 units on a scale
Quality of muscle reaction in supination2 units on a scale
Quality of muscle reaction in the neutral position of forearm2 units on a scale
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
60 Participants
Region of Enrollment
Turkey
60 participants
Severity of spasticity according to the Modified Ashworth Scale in forearm pronation3 units on a scale
Severity of spasticity according to the Modified Ashworth Scale in forearm supination3 units on a scale
Severity of spasticity according to the Modified Ashworth Scale in the neutral position of forearm3 units on a scale
Sex: Female, Male
Female
19 Participants
Sex: Female, Male
Male
41 Participants
Side of plegia
Left
34 Participants
Side of plegia
Right
26 Participants
Slow controlled motion (passive range of motion) of elbow joint in pronation180 degree
Slow controlled motion (passive range of motion) of elbow joint in supination180 degree
Slow controlled motion (passive range of motion) of elbow joint in the neutral position of forearm180 degree
Spontaneous elbow angle118.17 degree
STANDARD_DEVIATION 23.09
Type of stroke
Hemoragic
15 Participants
Type of stroke
Ischemic
45 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 60
other
Total, other adverse events
0 / 60
serious
Total, serious adverse events
0 / 60

Outcome results

Primary

Dynamic Component of Spasticity (Spasticity Angle)

According to the Modified Tardieu Scale, the difference between the angle of slow passive motion and the angle of muscle reaction represents the dynamic component of spasticity (spasticity angle) in degree. A big difference suggests spasticity while the low difference suggests muscular contracture. In this study, dynamic component of spasticity (spasticity angle) at forearm pronation, neutral position and supination was evaluated separately.

Time frame: 1 day (Only one measurement was performed in time (cross-sectional))

ArmMeasureValue (MEDIAN)
Spasticity Angle in PronationDynamic Component of Spasticity (Spasticity Angle)70 degree
Spasticity Angle in Neutral PositionDynamic Component of Spasticity (Spasticity Angle)60 degree
Spasticity Angle in SupinationDynamic Component of Spasticity (Spasticity Angle)57.5 degree
Comparison: Null hypothesis: no difference between dynamic components of elbow flexor spasticity (spasticity angle) in three different forearm positions. (Comparison groups were Spasticity angle in pronation, Spasticity angle in neutral position and Spasticity angle in supination)p-value: <0.001Friedman

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026