Cerebrovascular AccidentNCT00184431
Does Intensive Task Specific Training Improve Balance After Acute Stroke?
A study testing Physical therapy technique and exercises in people with Cerebrovascular Accident, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Physical therapy technique and exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2004to Apr 2008
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Admitted to the stroke unit with a diagnosis of stroke
- Living in the city of Trondheim
- Included 4 - 14 days after first sign of symptoms
- Modified Rankin Scale > 3 before admission to hospital
- Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points
- SSS leg item less than 6 points or SSS movement item less than 12 points
Show all 9Show fewer
- Discharged to home or a rehabilitation clinic
- Mini Mental State Examination Score more than 20 points
- Able and willing to provide informed consent
Who cannot join
- Seriously heart- and lung-diseases
- Other diseases which makes it difficult to evaluate the function
- Already included in the trial
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian University of Science and Technology
Trondheim, Trondheim, 7004
About this study
Official title: A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.
The aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.
Read the detailed description
Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another.
Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.
- Conditions
- Cerebrovascular Accident
- Being tested
- Physical therapy technique and exercises
- Keywords
- Cerebrovascular Accident, Physical Therapy Techniques, Musculoskeletal Equilibrium, Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy technique and exercisesBehavioural
The experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Intensive task specific balance training Receives: Behavioral: Physical therapy technique and exercises |
| B | Active comparator | Traditional physical therapy Receives: Behavioral: Physical therapy technique and exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Berg Balance Scale
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up
Secondary outcomes (10)
Mini Mental State Examination
Measured: Inclusion
Scandinavian Stroke Scale
Measured: Inclusion
Motor Assessment Scale
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Timed Up and Go
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Step Test
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Walking speed
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Barthel Index
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Modified Rankin Scale
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Fall Efficacy Scale
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Stroke Impact Scale
Measured: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startApr 2004
- Primary completionApr 2008
- Study completionApr 2008
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 Cerebrovascular AccidentStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
- Responsible party
- Sponsor
- Investigators
- Bent Indredavik, assoc-prof, Study chair, Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00184431
- Sponsor's protocol ID
- SU01-ISM-NTNU
- Status last verified
- Oct 2011
- First submitted
- 15 Sep 2005
- Last updated
- 18 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Askim T, Morkved S, Engen A, Roos K, Aas T, Indredavik B. Effects of a community-based intensive motor training program combined with early supported discharge after treatment in a comprehensive stroke unit: a randomized, controlled trial. Stroke. 2010 Aug;41(8):1697-703. doi: 10.1161/STROKEAHA.110.584284. Epub 2010 Jun 17.
PubMed 20558830
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Intensive Task Specific Training With Traditional Follow up Care After Discharge From a Stroke Unit.
- ClinicalTrials.gov ID
- NCT00184431
- Acronym / sponsor ID
- SU01-ISM-NTNU
- Conditions
- Cerebrovascular Accident
- Keywords
- Cerebrovascular Accident, Physical Therapy Techniques, Musculoskeletal Equilibrium, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Norwegian Fund for Postgraduate Training in Physiotherapy
- Study start
- Apr 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 16 Sep 2005 (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 aim of this study is to investigate whether additional task specific physiotherapy treatment and a self administrated home training program results in better balance compared to traditional follow up care.
Detailed description
Increased risk of falling is a major problem after stroke and impaired balance is one of the main reasons for falling. Early and intensive physiotherapy seems to be beneficial for functional outcome after stroke although it is still unknown whether one specific physiotherapy technique is better than another.
Comparison: Traditional follow up care by the community health care system with additional task specific physiotherapy three times a week and a daily self administrated home training program compared to traditional follow up care by the community health care system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Physical therapy technique and exercisesIntensive task specific balance training |
| B | Active comparator | Behavioral: Physical therapy technique and exercisesTraditional physical therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Admitted to the stroke unit with a diagnosis of stroke
- Living in the city of Trondheim
- Included 4 - 14 days after first sign of symptoms
- Modified Rankin Scale > 3 before admission to hospital
- Scandinavian Stroke Scale (SSS) less than 58 points and more than 14 points
Key exclusion criteria (3 listed)
- Seriously heart- and lung-diseases
- Other diseases which makes it difficult to evaluate the function
- Already included in the trial
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 |
|---|---|---|
| Physical therapy technique and exercisesThe experimental group receives task specific physical therapy three times a week for the first four weeks after discharge from hospital and one session pr week for the next eight weeks in addition to ordinary physical therapy The active comparator group receives only ordinary physical therapy during this period. | Behavioural | A, B |
Primary outcome
The Berg Balance Scale
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up
10 secondary outcomes
Mini Mental State Examination
Time frame: Inclusion
Scandinavian Stroke Scale
Time frame: Inclusion
Motor Assessment Scale
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Timed Up and Go
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Step Test
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Walking speed
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Barthel Index
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Modified Rankin Scale
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Fall Efficacy Scale
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
Stroke Impact Scale
Time frame: Inclusion, four weeks follow-up, twelve weeks follow-up, six months follow-up
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 18 Oct 2011.
- Results publication: PubMed 20558830Askim T, Morkved S, Engen A, Roos K, Aas T, Indredavik B. Effects of a community-based intensive motor training program combined with early supported discharge after treatment in a comprehensive stroke unit: a randomized, controlled trial. Stroke. 2010 Aug;41(8):1697-703. doi: 10.1161/STROKEAHA.110.584284. Epub 2010 Jun 17.
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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.
Bent Indredavik, assoc-prof study chair
Department of Neuroscience, Faculty of Medicine, Norwegian university of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy technique and exercises in people with Cerebrovascular Accident, run by Norwegian University of Science and Technology 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 9 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: finished, as of the sponsor's last update on 18 Oct 2011. 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.
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?
The Berg Balance Scale (time frame: Inclusion, four weeks follow-up, twelve weeks follow-up and six months follow-up). 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 NCT00184431, 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 18 Oct 2011.