StrokeNCT00776386
Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Stroke
An observational study of Stroke and "Rehabilitation", run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study has two purposes. First, the investigators will identify determinants of changes in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID) analysis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, "Rehabilitation"
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to Jun 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: a group of stroke patients
Who may be able to join
- A first-ever unilateral stroke onset at least 6 months previously
- Demonstration of Brunnstrom stage > III for the proximal part of UE
- Considerable nonuse of the more affected upper extremity (MAL amount of use score < 2.5);5
- No balance problems sufficient to compromise safety when wearing the constraint mitt
- Willing to provide written informed consent.
Who cannot join
- To avoid the confounding effects of cognitive and medical conditions, potential subjects will be excluded if the medical or physical screening exam reveals a score of less than 24 on the Mini Mental State Exam
- 32 physician-determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Distributed Constraint-Induced Therapy in Stroke
This study has two purposes. First, the investigators will identify determinants of changes in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID) analysis. The results will help target which types/characteristics of patients will benefit most from the intervention and may identify different determinants across different levels of outcomes. Secondly, in order to understand the extent of treatment effect in terms of clinical relevance, the investigators will examine whether the change scores on measures of motor ability, activities of daily living, and HRQOL after distributed CIT reach clinically important differences or not.
Read the detailed description
Stroke is a major cause of long-term disability in many countries. More than 50% of stroke survivors experience resultant upper extremity (UE) movement impairments that lead to activity limitations and restriction of participation. Various contemporary rehabilitation strategies which aim to improve UE motor deficits after stroke have been proposed. Constraint-induced therapy (CIT) is one of the current promising approaches, and numerous CIT and distributed CIT studies have shown substantial evidence of positive treatment effects.
Although studies have shown a form of distributed CIT can enhance motor function of the affected UE, functional performance, and some aspects of HRQOL post stroke, determinants related to distributed CIT outcomes remain unclear. In addition, mismatch between the statistically significant and clinically important differences (CID) for change scores has been identified as a limitation of CIT studies. Investigation of CID is critical for understanding the clinically relevant meanings of change scores after intervention. Therefore, the purposes of this project are to (1) identify determinants of changes in motor ability, functional performance, and HRQOL after distributed CIT for patients with stroke using the Chi-squared Automatic Interaction Detector analysis; (2) examine whether the change scores on outcome measures after distributed CIT reach CID.
Within the one year, we plan to complete cumulated data of distributed CIT trials for 70 subjects. The distributed CIT intervention will be provided by two certified occupational therapists. The Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), Functional Independence Measure (FIM), and Stroke Impact Scale (SIS) will be used as outcome measures in this project. Six potential predictors will be selected for the FMA, WMFT and FIM, and seven potential predictors will be selected for the SIS based on previous empirical findings and theoretical basis. CHAID analysis will be used to identify the specific determinants and the best split points of the determinants. In addition, based on Cohen's effect size benchmark, if the change scores on the FMA, WMFT, FIM and SIS exceeded 0.2SD will be considered as CID.
After the one-year project, we will identify the determinants of motor ability, functional performance, and HRQOL after distributed CIT and thus can help understand the factors that may affect treatment outcomes and target patients who benefit most from this intervention. Additionally, we will provide the results of CID for better evaluation and interpretation of the change scores after distributed CIT.
- Conditions
- Stroke, "Rehabilitation"
- Medical subject headings
- Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Keh-chung Lin, ScD, OTR, Study director, Occupational Therapy Services, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776386
- Sponsor's protocol ID
- 200805052R
- Status last verified
- Jul 2008
- First submitted
- 19 Oct 2008
- Last updated
- 21 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Distributed Constraint-Induced Therapy in Stroke
- ClinicalTrials.gov ID
- NCT00776386
- Acronym / sponsor ID
- 200805052R
- Conditions
- Stroke, "Rehabilitation"
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 21 Oct 2008 (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.
This study has two purposes. First, the investigators will identify determinants of changes in motor ability, activities of daily living, and HRQOL after distributed Constraint-induced therapy for patients with stroke with the Chi-squared Automatic Interaction Detector (CHAID) analysis. The results will help target which types/characteristics of patients will benefit most from the intervention and may identify different determinants across different levels of outcomes. Secondly, in order to understand the extent of treatment effect in terms of clinical relevance, the investigators will examine whether the change scores on measures of motor ability, activities of daily living, and HRQOL after distributed CIT reach clinically important differences or not.
Detailed description
Stroke is a major cause of long-term disability in many countries. More than 50% of stroke survivors experience resultant upper extremity (UE) movement impairments that lead to activity limitations and restriction of participation. Various contemporary rehabilitation strategies which aim to improve UE motor deficits after stroke have been proposed. Constraint-induced therapy (CIT) is one of the current promising approaches, and numerous CIT and distributed CIT studies have shown substantial evidence of positive treatment effects.
Although studies have shown a form of distributed CIT can enhance motor function of the affected UE, functional performance, and some aspects of HRQOL post stroke, determinants related to distributed CIT outcomes remain unclear. In addition, mismatch between the statistically significant and clinically important differences (CID) for change scores has been identified as a limitation of CIT studies. Investigation of CID is critical for understanding the clinically relevant meanings of change scores after intervention. Therefore, the purposes of this project are to (1) identify determinants of changes in motor ability, functional performance, and HRQOL after distributed CIT for patients with stroke using the Chi-squared Automatic Interaction Detector analysis; (2) examine whether the change scores on outcome measures after distributed CIT reach CID.
Within the one year, we plan to complete cumulated data of distributed CIT trials for 70 subjects. The distributed CIT intervention will be provided by two certified occupational therapists. The Fugl-Meyer Assessment (FMA), Wolf Motor Function Test (WMFT), Functional Independence Measure (FIM), and Stroke Impact Scale (SIS) will be used as outcome measures in this project. Six potential predictors will be selected for the FMA, WMFT and FIM, and seven potential predictors will be selected for the SIS based on previous empirical findings and theoretical basis. CHAID analysis will be used to identify the specific determinants and the best split points of the determinants. In addition, based on Cohen's effect size benchmark, if the change scores on the FMA, WMFT, FIM and SIS exceeded 0.2SD will be considered as CID.
After the one-year project, we will identify the determinants of motor ability, functional performance, and HRQOL after distributed CIT and thus can help understand the factors that may affect treatment outcomes and target patients who benefit most from this intervention. Additionally, we will provide the results of CID for better evaluation and interpretation of the change scores after distributed CIT.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- a group of stroke patients
Key inclusion criteria (5 listed)
- A first-ever unilateral stroke onset at least 6 months previously
- Demonstration of Brunnstrom stage > III for the proximal part of UE
- Considerable nonuse of the more affected upper extremity (MAL amount of use score < 2.5);5
- No balance problems sufficient to compromise safety when wearing the constraint mitt
- Willing to provide written informed consent.
Key exclusion criteria (3 listed)
- To avoid the confounding effects of cognitive and medical conditions, potential subjects will be excluded if the medical or physical screening exam reveals a score of less than 24 on the Mini Mental State Exam
- 32 physician-determined major medical problems or poor physical conditions that would interfere with participation
- Excessive pain in any joint that might limit participation.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2008.
Related trials for Stroke
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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.
Keh-chung Lin, ScD, OTR study director
Occupational Therapy Services, National Taiwan University Hospital
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 and "Rehabilitation", run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 21 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 Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 21 Oct 2008.