Cerebral StrokePhase 1/2NCT00311025
Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications?
A Phase 1/2 study testing intensive endurance, strength and balance exercises in people with Cerebral Stroke, run by Oslo University College at 1 site in Norway.
Trial summary
The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke and study the effect of two different approaches of exercises implemented the first year post-stroke. Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Cerebral Stroke
- What is being tested?
- intensive endurance, strength and balance exercises
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2003to Sep 2005
- Phase
- Phase 1/2
- 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 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- First-time ever stroke
- Neurological signs
- Computer tomography confirmed stroke
- Voluntary participation
Who cannot join
- Subarachnoid bleeding
- Tumour
- Other serious illness
- Brain stem or cerebellum stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.
The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke and study the effect of two different approaches of exercises implemented the first year post-stroke.
Read the detailed description
Stroke is a major cause of disability and the long-term effects of stroke often lead to need of rehabilitation services. It has been shown that intensive stroke unit care and functional exercises are beneficial in the acute rehabilitation of stroke. The duration of the rehabilitation of patients with acute stroke is decreasing, leaving patients with not complete recovery at discharge in need of follow-up services. There is a general assumption that physical exercises are beneficial at all stages of stroke but it is questionable if these benefits are sustained after treatment ends. There are, to our knowledge, no longitudinal studies of non-interrupted regular physical exercises from the acute phase till one year post stroke.
The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke. All acute stroke patients will be treated in a stroke unit and the physiotherapy treatment will be according to Motor Relearning Programme principles with functional goals, environmental context and early mobilisation. When patients are discharged they will be block randomised and stratified according to gender and hemisphere lesion into two groups. Group 1 will be offered an intensive follow-up programme, which will run four times in the post-stroke year with a total amount of 80 hours of physiotherapy. The physiotherapy treatment will be focused on physical endurance, strength and balance.
Group 2, or the control group, will be offered the same physiotherapy programme that is practised within the community as of now (2003) that is when the need for follow-up is considered by someone involved. The physiotherapy then given is according to specified needs e.g. walking capacity, transfers and assistive devices.
- Conditions
- Cerebral Stroke
- Being tested
- intensive endurance, strength and balance exercises
- Keywords
- stroke, physical therapy, rehabilitation, exercise, longterm follow-up
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive endurance, strength and balance exercisesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Assessment Scale
Secondary outcomes (10)
Bergs Balance Scale,
Timed-Up-and-Go,
6 minute walk test,
Nottingham Health Profile,
Martin Vigorimeter,
Ashworth Scale,
Barthel ADL index,
Fillenbaum´s I-ADL,
blood pressure,
heart rate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Oslo University College
- Sponsor type
- University, hospital or other
- Investigators
- Birgitta M Langhammer, phd student, Principal investigator, Oslo University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311025
- Sponsor's protocol ID
- S-03054
- Status last verified
- Sep 2005
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke: Reduction of Physical Performance Post Stroke. Inactivity or Secondary Complications? How to Cope Daily Life Activities for as Long as Possible.
- ClinicalTrials.gov ID
- NCT00311025
- Acronym / sponsor ID
- S-03054
- Conditions
- Cerebral Stroke
- Keywords
- stroke, physical therapy, rehabilitation, exercise, longterm follow-up
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- Oslo University CollegeUniversity, hospital or other
- Study start
- Sep 2003
- Study completion
- Sep 2005
- First posted
- 5 Apr 2006 (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 this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke and study the effect of two different approaches of exercises implemented the first year post-stroke.
Detailed description
Stroke is a major cause of disability and the long-term effects of stroke often lead to need of rehabilitation services. It has been shown that intensive stroke unit care and functional exercises are beneficial in the acute rehabilitation of stroke. The duration of the rehabilitation of patients with acute stroke is decreasing, leaving patients with not complete recovery at discharge in need of follow-up services. There is a general assumption that physical exercises are beneficial at all stages of stroke but it is questionable if these benefits are sustained after treatment ends. There are, to our knowledge, no longitudinal studies of non-interrupted regular physical exercises from the acute phase till one year post stroke.
The purpose of this project is to follow first-ever- acute stroke patients from onset, one, two and four years post stroke. All acute stroke patients will be treated in a stroke unit and the physiotherapy treatment will be according to Motor Relearning Programme principles with functional goals, environmental context and early mobilisation. When patients are discharged they will be block randomised and stratified according to gender and hemisphere lesion into two groups. Group 1 will be offered an intensive follow-up programme, which will run four times in the post-stroke year with a total amount of 80 hours of physiotherapy. The physiotherapy treatment will be focused on physical endurance, strength and balance.
Group 2, or the control group, will be offered the same physiotherapy programme that is practised within the community as of now (2003) that is when the need for follow-up is considered by someone involved. The physiotherapy then given is according to specified needs e.g. walking capacity, transfers and assistive devices.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- First-time ever stroke
- Neurological signs
- Computer tomography confirmed stroke
- Voluntary participation
Key exclusion criteria (4 listed)
- Subarachnoid bleeding
- Tumour
- Other serious illness
- Brain stem or cerebellum stroke
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 |
|---|---|---|
| intensive endurance, strength and balance exercises | Procedure or surgery | – |
Primary outcome
Motor Assessment Scale
10 secondary outcomes
Bergs Balance Scale,
Timed-Up-and-Go,
6 minute walk test,
Nottingham Health Profile,
Martin Vigorimeter,
Ashworth Scale,
Barthel ADL index,
Fillenbaum´s I-ADL,
blood pressure,
heart rate
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 5 Apr 2006.
Related trials for Cerebral Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Birgitta M Langhammer, phd student principal investigator
Oslo University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing intensive endurance, strength and balance exercises in people with Cerebral Stroke, run by Oslo University College at 1 site in Norway.
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 4 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 5 Apr 2006. 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 Norway. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Motor Assessment Scale. 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 5 Apr 2006.