Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Stroke
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| ClinicalTrials.gov Identifier: NCT00776386 |
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Recruitment Status : Unknown
Verified July 2008 by National Taiwan University Hospital.
Recruitment status was: Active, not recruiting
First Posted : October 21, 2008
Last Update Posted : October 21, 2008
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| Condition or disease |
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| Stroke "Rehabilitation" |
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 Type : | Observational |
| Estimated Enrollment : | 70 participants |
| Observational Model: | Cohort |
| Time Perspective: | Cross-Sectional |
| Official Title: | Determinants and Practical Significance of Change in Motor Ability, Functional Performance, and HRQOL After Distributed Constraint-Induced Therapy in Stroke |
| Study Start Date : | July 2008 |
| Estimated Primary Completion Date : | June 2009 |
| Estimated Study Completion Date : | June 2009 |
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776386
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
| Study Director: | Keh-chung Lin, ScD, OTR | Occupational Therapy Services, National Taiwan University Hospital |
| Responsible Party: | Keh-chung Lin, School of Occupational Therapy, College of Medicine, National Taiwan University |
| ClinicalTrials.gov Identifier: | NCT00776386 |
| Other Study ID Numbers: |
200805052R |
| First Posted: | October 21, 2008 Key Record Dates |
| Last Update Posted: | October 21, 2008 |
| Last Verified: | July 2008 |
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Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |