Post-stroke Elbow SpasticityNCT03563209

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

An observational study of Post-stroke Elbow Spasticity, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Post-stroke Elbow Spasticity
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Mar 2018to 15 Aug 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with post-stroke elbow flexor spasticity

Who may be able to join

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

Who cannot join

<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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ilker Şengül
Izmir, In the USA Or Canada, Please Select..., 35360

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Conditions: Post-stroke Elbow Spasticity
Keywords: Elbow spasticity, Stroke
Medical subject headings: Stroke

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day (Only one measurement was performed in time (cross-sectional))

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201815 Aug 2018

First posted20 Jun 2018
Study start15 Mar 2018
Primary completion15 Aug 2018
Study completion15 Aug 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Post-stroke Elbow SpasticityStudies 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: Case only
Time perspective: Cross-sectional
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03563209
Sponsor's protocol ID: 21.02.2018-84
Status last verified: May 2019
First submitted: 6 Jun 2018
Last updated: 22 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Keenan MA. Management of the spastic upper extremity in the neurologically impaired adult. Clin Orthop Relat Res. 1988 Aug;(233):116-25.
PubMed 3042230
Genet F, Schnitzler A, Droz-Bartholet F, Salga M, Tatu L, Debaud C, Denormandie P, Parratte B. Successive motor nerve blocks to identify the muscles causing a spasticity pattern: example of the arm flexion pattern. J Anat. 2017 Jan;230(1):106-116. doi: 10.1111/joa.12538. Epub 2016 Sep 6.
PubMed 27595994
Keenan MA, Haider TT, Stone LR. Dynamic electromyography to assess elbow spasticity. J Hand Surg Am. 1990 Jul;15(4):607-14. doi: 10.1016/s0363-5023(09)90023-5.
PubMed 2380525
BASMAJIAN JV, LATIF A. Integrated actions and functions of the chief flexors of the elbow: a detailed electromyographic analysis. J Bone Joint Surg Am. 1957 Oct;39-A(5):1106-18. No abstract available.
PubMed 13475410
Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
PubMed 3809245
Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.
PubMed 20927007

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assesment of Post-stroke Elbow Flexor Spasticity in Response to Passive Stretch in Different Forearm Positions
ClinicalTrials.gov ID: NCT03563209
Acronym / sponsor ID: 21.02.2018-84
Conditions: Post-stroke Elbow Spasticity
Keywords: Elbow spasticity, Stroke
Study type: Observational
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Izmir Katip Celebi UniversityUniversity, hospital or other
Study start: 15 Mar 2018 (actual)
Primary completion: 15 Aug 2018 (actual)
Study completion: 15 Aug 2018 (actual)
First posted: 20 Jun 2018 (actual)
Results: Posted 10 May 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Observational model: Case only
Time perspective: Cross-sectional

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with post-stroke elbow flexor spasticity

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

<18 years old
Pregnancy
Botulinum toxin injection within the last three months
Presence of elbow contracture
History of operation to spastic upper extremity

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Dynamic Component of Spasticity (Spasticity Angle)
Time frame: 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.

Results and safety

Results posted to the registry on 10 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Post-stroke Elbow Flexor Spasticity	60	60

Primary outcome: Dynamic Component of Spasticity (Spasticity Angle)

Time frame: 1 day (Only one measurement was performed in time (cross-sectional)). Median (Inter-Quartile Range). Unit: degree

Measure	Spasticity Angle in Pronation n = 60	Spasticity Angle in Neutral Position n = 60	Spasticity Angle in Supination n = 60
Value	70 (50 to 80)	60 (50 to 75)	57.5 (30 to 70)

Spasticity Angle in Pronation vs Spasticity Angle in Neutral Position vs Spasticity Angle in Supination: p <0.001, Friedman

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Post-stroke Elbow Flexor Spasticity	0 of 60 (0%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): Technical problems related to measurement in determining muscle reaction angle and slow controlled motion with a standard goniometer. The use of semi-quantitative spasticity assessment scales.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3042230Keenan MA. Management of the spastic upper extremity in the neurologically impaired adult. Clin Orthop Relat Res. 1988 Aug;(233):116-25.
Background: PubMed 27595994Genet F, Schnitzler A, Droz-Bartholet F, Salga M, Tatu L, Debaud C, Denormandie P, Parratte B. Successive motor nerve blocks to identify the muscles causing a spasticity pattern: example of the arm flexion pattern. J Anat. 2017 Jan;230(1):106-116. doi: 10.1111/joa.12538. Epub 2016 Sep 6.
Background: PubMed 2380525Keenan MA, Haider TT, Stone LR. Dynamic electromyography to assess elbow spasticity. J Hand Surg Am. 1990 Jul;15(4):607-14. doi: 10.1016/s0363-5023(09)90023-5.
Background: PubMed 13475410BASMAJIAN JV, LATIF A. Integrated actions and functions of the chief flexors of the elbow: a detailed electromyographic analysis. J Bone Joint Surg Am. 1957 Oct;39-A(5):1106-18. No abstract available.
Background: PubMed 3809245Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther. 1987 Feb;67(2):206-7. doi: 10.1093/ptj/67.2.206.
Background: PubMed 20927007Gracies JM, Bayle N, Vinti M, Alkandari S, Vu P, Loche CM, Colas C. Five-step clinical assessment in spastic paresis. Eur J Phys Rehabil Med. 2010 Sep;46(3):411-21.
Individual participant dataSharing planned: No

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.

ilker şengül principal investigator

İzmir Katip Çelebi University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Post-stroke Elbow Spasticity, run by Izmir Katip Celebi University at 1 site in Turkey (Türkiye).

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 3 inclusion and 7 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 22 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). 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?

Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dynamic Component of Spasticity (Spasticity Angle) (time frame: 1 day (Only one measurement was performed in time (cross-sectional))). 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 NCT03563209, which also lists 6 linked publications.

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 22 May 2019.