Cerebrovascular AccidentPhase 2NCT00377689
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke
A Phase 2 study testing high intensity functional exercise in people with Cerebrovascular Accident and Musculoskeletal Equilibrium, run by Umeå University at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cerebrovascular Accident, Musculoskeletal Equilibrium
- What is being tested?
- high intensity functional exercise
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 34 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2006to Apr 2008
- Phase
- Phase 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years of age or older
- stroke diagnosis 3-6 months prior to inclusion
- ability to walk 10 meter with or without assistive device
- ability to understand simple instructions
Who cannot join
- TIA
- independent in walking outdoors
- serious visual impairment
- serious hearing impairment
- long distance to intervention station
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Umeå University, department of Community science and rehabilitation
Umeå, 90137
About this study
Official title: Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study
The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.
Read the detailed description
Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy.
High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population.
Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.
- Being tested
- high intensity functional exercise
- Keywords
- Accidental falls, Cerebrovascular accident, Balance, ADL, Self efficacy, Quality of Life, Gait parameters
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high intensity functional exerciseBehavioural
high intensity functional exercise
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in balance
Measured: post, 3 & 6 months
Secondary outcomes (4)
Reduced falls
Measured: post, 3 & 6 months
Improved self-efficacy
Measured: post, 3 & 6 months
Improved ADL
Measured: post, 3 & 6 months
Improved walking ability
Measured: post, 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Vardalinstitutet The Swedish Institute for Health Sciences, Erik & AnnMarie Detlofs Foundation, The Swedish National Stroke society, The Northern County Councils Regional Federation
- Investigators
- Eva Holmgren, PhD student, Principal investigator, Umeå University & The Vårdal InstitutePer Wester, MD Professor, Study chair, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377689
- Sponsor's protocol ID
- Dnr 04-022
- Status last verified
- Oct 2008
- First submitted
- 15 Sep 2006
- Last updated
- 29 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT00377689
- Acronym / sponsor ID
- Dnr 04-022
- Keywords
- Accidental falls, Cerebrovascular accident, Balance, ADL, Self efficacy, Quality of Life, Gait parameters
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Vardalinstitutet The Swedish Institute for Health Sciences, Erik & AnnMarie Detlofs Foundation, The Swedish National Stroke society, The Northern County Councils Regional Federation
- Study start
- Sep 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 18 Sep 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 study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.
Detailed description
Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy.
High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population.
Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 55 years of age or older
- stroke diagnosis 3-6 months prior to inclusion
- ability to walk 10 meter with or without assistive device
- ability to understand simple instructions
Key exclusion criteria (5 listed)
- TIA
- independent in walking outdoors
- serious visual impairment
- serious hearing impairment
- long distance to intervention station
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 |
|---|---|---|
| high intensity functional exercisehigh intensity functional exercise | Behavioural | – |
Primary outcome
Improvement in balance
Time frame: post, 3 & 6 months
4 secondary outcomes
Reduced falls
Time frame: post, 3 & 6 months
Improved self-efficacy
Time frame: post, 3 & 6 months
Improved ADL
Time frame: post, 3 & 6 months
Improved walking ability
Time frame: post, 3 & 6 months
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 29 Oct 2008.
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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.
Eva Holmgren, PhD student principal investigator
Umeå University & The Vårdal Institute
Per Wester, MD Professor study chair
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing high intensity functional exercise in people with Cerebrovascular Accident and Musculoskeletal Equilibrium, run by Umeå University at 1 site in Sweden.
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 5 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 29 Oct 2008. 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 Sweden. 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 phase mean?
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?
Improvement in balance (time frame: post, 3 & 6 months). 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 29 Oct 2008.