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| Name | Class |
|---|---|
| Heart and Stroke Foundation of Ontario | OTHER |
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Once discharged from hospital many stroke survivors deteriorate medically, physically and in their mobility function and many report their level of function and quality of life to be poor 12 months after inpatient rehabilitation. There is an identified need for follow-up examinations of community dwelling stroke survivors to monitor changes in function and it has been suggested that maintenance therapy could curtail declines in function. The purpose of this trial is to determine whether brief periods of intense client-centered rehabilitation therapy (tune-ups) provided at 6 month intervals can alter the natural progression of impairment (physical capacity), function and community reintegration following stroke.
The extent to which impairment (physical capacity) and function influence community reintegration is unclear. One of the challenges is that physical parameters change over time as does the person's awareness and perception of what activities are important to be able to engage in at the community level. Interventions have led to gains in physical capacity, function and community reintegration, but the benefits have been shown to dissipate within three to six months. It has been suggested that maintenance therapy (tune-ups) for stroke survivors post-discharge could prevent or curtail decline in function of aging stroke survivors and enhance quality of life and well being; constructs that relate strongly to community reintegration. This study will determine whether tune-ups can alter the time course and magnitude of changes in physical capacity and function and their influence on community reintegration. Stroke survivors discharged from rehabilitation will be followed for a 15 month period with laboratory or home assessments conducted at 3 month intervals. Assessors will be blind to whether the subject is receiving a tune up. Evaluations conducted after the tune-up at 9 months and 12 months post-discharge will allow us to determine if the tune-up effectively reduced physical impairment, improved function and resulted in better community reintegration compared to control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | natural progression post-stroke | |
| Intervention | Experimental | two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical rehabilitation | Behavioral | two weeks intensive physical rehabilitation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Index of Physical and Social Outcome (SIPSO) | The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration. | baseline and 1 year |
| Subjective Index of Social Integration (Subscale of SIPSO) | see Subjective Index of Physical and Social Outcome (SIPSO) above | baseline and one year |
| Subjective Index of Physical Integration (Subscale of SIPSO) | see 'Subjective Index of Physical and Social Outcome (SIPSO) above | baseline and one year |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility Function | Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds) | baseline and 1 year |
| Physical Capacity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brenda J Brouwer, PhD | Queen's University | Principal Investigator |
| Jayne Garland, Ph.D | Western University, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen's University School of Rehabilitation Therapy | Kingston | Ontario | K7L 3N6 | Canada | ||
| School of Physical Therapy, University of Western Ontario |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29412167 | Derived | Brouwer B, Bryant D, Garland SJ. Effectiveness of Client-Centered "Tune-Ups" on Community Reintegration, Mobility, and Quality of Life After Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Jul;99(7):1325-1332. doi: 10.1016/j.apmr.2017.12.034. Epub 2018 Apr 3. | |
| 29317222 | Derived | Cohen JW, Ivanova TD, Brouwer B, Miller KJ, Bryant D, Garland SJ. Do Performance Measures of Strength, Balance, and Mobility Predict Quality of Life and Community Reintegration After Stroke? Arch Phys Med Rehabil. 2018 Apr;99(4):713-719. doi: 10.1016/j.apmr.2017.12.007. Epub 2018 Jan 6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | no intervention, natural history following stroke |
| FG001 | Intervention | two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Hemiparetic stroke (hemorrhagic or ischemic), first ever associated with residual deficits/impairments (i.e. full recovery from previous stoke if applicable)
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | natural progression post-stroke |
| BG001 | Intervention | two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year) physical rehabilitation: two weeks intensive physical rehabilitation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Index of Physical and Social Outcome (SIPSO) | The SIPSO is a 10-item measure developed specifically for stroke that includes a Physical Integration Subscale relating to activities and daily living and a Social Integration subscale relating to social adaptation. Each item is assessed on an ordinal scale from 0 (cannot perform the task or activity/completely dissatisfied) to 4 (no difficultly/completely satisfied) such that the minimum score is 0 and the maximum for each subscale is 20 and the maximum total score is 40 (sum of subscales). The total score reflects reintegration. | those who completed 1 year testing | Posted | Mean | Standard Deviation | scores on a scale | baseline and 1 year |
|
over one year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | natural progression post-stroke |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brenda Brouwer | Queen's University | 613-533-6079 | brouwerb@queensu.ca |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded.
| baseline and 12 months |
| Health-related Quality of Life - Physical | The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best. | baseline and one year |
| Health-related Quality of Life - Mental | The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest. | baseline and one year |
| London |
| Ontario |
| N6G 1H1 |
| Canada |
| Physician Decision |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Admission Functional Independence | The Functional Independence Measure (FIM) is an instrument that provides an indication of an individual's level of disability and their ability to perform activities of daily living (ADL). Eighteen (18) ADL-related motor and cognitive items are each rated on an ordinal scale ranging from complete dependence (1) to complete independence (7). The total FIM score ranges from 18 (lowest) to 126 (highest, complete independence). | Mean | Standard Deviation | units on a scale |
|
| Balance ability | The Berg Balance Scale (BBS) is composed of 14 items that require the individual to perform specific balance tasks ranging from basic (e.g. sit-to-stand, unsupported standing) to more difficult (e.g. standing on one leg). Each item is scored on an ordinal scale from 0 (unable to perform) to 4 (able to complete independently and/or safely). The total score ranges from 0 (lowest) to 56 (highest). | Mean | Standard Deviation | units on a scale |
|
| living setting pre-stroke | Number | participants |
|
| mental status (MMSE) | The Mini-Mental State Exam (MMSE) is a screening tool for cognitive impairment. It is an 11 item questionnaire that tests five areas of cognitive function including orientation, attention and recall. A maximum score is 30 (total number of correct responses, 1 to 5 per question). A score of 23 or lower indicates cognitive impairment. | Mean | Standard Deviation | points |
|
| paretic side | Number | participants |
|
| Intervention |
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year) physical rehabilitation: two weeks intensive physical rehabilitation |
|
|
|
| Secondary | Mobility Function | Timed up and go - participants stand from a seated position on a chair with armrests, walk 3 meters, turn and return to a seated position (measured in seconds) | those still enrolled at primary endpoint (one year) | Posted | Mean | Standard Deviation | seconds | baseline and 1 year |
|
|
|
|
| Secondary | Physical Capacity | 6 minute walk test (6MWT). Subjects were instructed to walk as far as possible over 6 minutes with rests as needed and the distance traveled was recorded. | all those enrolled at primary endpoint - 1 year | Posted | Mean | Standard Deviation | meters | baseline and 12 months |
|
|
|
|
| Secondary | Health-related Quality of Life - Physical | The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Physical component summary (PCS) score takes into account the physical health domains (physical function, role-physical and bodily pain) and scores self-reported physical health on a scale from 0 to 100, where 0 is the lowest rating of physical health and 100, the highest or best. | those enrolled at primary endpoint (one year) | Posted | Mean | Standard Deviation | points | baseline and one year |
|
|
|
|
| Secondary | Health-related Quality of Life - Mental | The SF-36 contains 36 questions pertaining to 8 health-related domains (physical and social function, emotional and physical limitation (role-emotional/role-physical), mental health, vitality, bodily pain, and general health). The derivation of the Mental component summary (MCS) score takes into account the mental health domains (social function, role-emotional and mental health) and scores self-reported mental health on a scale from 0 to 100, where 0 is the lowest rating of mental health and 100, the highest. | those enrolled at 1 year (primary endpoint) | Posted | Mean | Standard Deviation | points | baseline and one year |
|
|
|
|
| Primary | Subjective Index of Social Integration (Subscale of SIPSO) | see Subjective Index of Physical and Social Outcome (SIPSO) above | those who completed 1 year testing | Posted | Mean | Standard Deviation | points on a scale | baseline and one year |
|
|
|
|
| Primary | Subjective Index of Physical Integration (Subscale of SIPSO) | see 'Subjective Index of Physical and Social Outcome (SIPSO) above | those who completed 1 year testing | Posted | Mean | Standard Deviation | points on a scale | baseline and one year |
|
|
|
|
| 0 |
| 52 |
| 0 |
| 52 |
| EG001 | Intervention | two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year) physical rehabilitation: two weeks intensive physical rehabilitation | 0 | 51 | 0 | 51 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |