StrokeNCT01041560
Muscle Tone Changes in Acute Stroke According to Brain Injury
An observational study of Stroke, run by Jyväskylä Central Hospital at 1 site in Finland.
Trial summary
The purpose of the study is to examine connections between muscle tones, strength and function after stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 100 participants
- Where
- 1 siteFinland
- Study dates
- Sep 2008to Dec 2010
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke patients in Middle-Finland Central hospital
Who may be able to join
- unilateral decline in the arm or leg muscle strength
Who cannot join
- unwilling to take part on the trial
- not conscious
- no differences between muscle strength on the right and left side
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Central Finland Health Care District
Jyväskylä, 40740
Jari Ylinen, MD, PhD
About this study
Official title: Muscle Tone Changes in Acute Stroke According to Brain Injury in Relation to Changes in Functioning
The purpose of the study is to examine connections between muscle tones, strength and function after stroke.
Read the detailed description
Measurements are intended to repeat every two days in acute phase to discover possible changes in tone and strength in arm and leg muscles.
- Conditions
- Stroke
- Keywords
- Stroke, Tone, Strength
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stoke | Hemiplegia with unilateral changes in tone and muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone
Measured: Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital
Secondary outcomes (1)
Muscle strength
Measured: Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2009 (estimated)
- Study startSep 2008
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eurostars
- Investigators
- Jari Ylinen, MD, PhD, Study director, Senior physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041560
- Sponsor's protocol ID
- KSKS2
- Status last verified
- Dec 2009
- First submitted
- 30 Dec 2009
- Last updated
- 31 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Tone Changes in Acute Stroke According to Brain Injury in Relation to Changes in Functioning
- ClinicalTrials.gov ID
- NCT01041560
- Acronym / sponsor ID
- KSKS2
- Conditions
- Stroke
- Keywords
- Stroke, Tone, Strength
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Collaborators
- Eurostars
- Study start
- Sep 2008
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 31 Dec 2009 (estimated)
- 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 purpose of the study is to examine connections between muscle tones, strength and function after stroke.
Detailed description
Measurements are intended to repeat every two days in acute phase to discover possible changes in tone and strength in arm and leg muscles.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stoke | – | –Hemiplegia with unilateral changes in tone and muscle strength |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke patients in Middle-Finland Central hospital
Key inclusion criteria (1 listed)
- unilateral decline in the arm or leg muscle strength
Key exclusion criteria (3 listed)
- unwilling to take part on the trial
- not conscious
- no differences between muscle strength on the right and left side
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
Muscle tone
Time frame: Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital
1 secondary outcome
Muscle strength
Time frame: Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2009.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Jari Ylinen, MD, PhD study director
Senior physician
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 Stroke, run by Jyväskylä Central Hospital at 1 site in Finland.
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 3 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: status not confirmed, as of the sponsor's last update on 31 Dec 2009. 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 Finland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jari Ylinen, MD, PhD (+358142691145, jari.ylinen@ksshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle tone (time frame: Immediately after stroke, during the first week in hospital every other day, and then once a week before discharging from hospital). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2009.