Stroke
Conditions
Keywords
mobility, strength, balance, function, reintegration, community
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALphysical rehabilitation
two weeks intensive physical rehabilitation
Sponsors
Heart and Stroke Foundation of Ontario
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* first major unilateral hemispheric stroke, * english speaking, * adequate verbal communication, * discharged home or residential care
Exclusion criteria
* serious comorbidities (eg. cancer, mobility limiting arthritis, leg amputation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Index of Physical and Social Outcome (SIPSO) | baseline and 1 year | 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. |
| Subjective Index of Social Integration (Subscale of SIPSO) | baseline and one year | see Subjective Index of Physical and Social Outcome (SIPSO) above |
| Subjective Index of Physical Integration (Subscale of SIPSO) | baseline and one year | see 'Subjective Index of Physical and Social Outcome (SIPSO) above |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mobility Function | baseline and 1 year | 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) |
| Health-related Quality of Life - Mental | baseline and one year | 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. |
| Physical Capacity | baseline and 12 months | 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. |
| Health-related Quality of Life - Physical | baseline and one year | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control natural progression post-stroke | 52 |
| Intervention two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation | 51 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Physician Decision | 5 | 4 |
| Overall Study | Withdrawal by Subject | 11 | 12 |
Baseline characteristics
| Characteristic | Total | Intervention | Control |
|---|---|---|---|
| Admission Functional Independence | 98.4 units on a scale STANDARD_DEVIATION 22.7 | 100.5 units on a scale STANDARD_DEVIATION 22.1 | 96.2 units on a scale STANDARD_DEVIATION 23.4 |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 1.8 | 62.7 years STANDARD_DEVIATION 1.7 | 62.1 years STANDARD_DEVIATION 1.8 |
| Balance ability | 46.6 units on a scale STANDARD_DEVIATION 12.8 | 47.8 units on a scale STANDARD_DEVIATION 11.9 | 45.4 units on a scale STANDARD_DEVIATION 13.5 |
| living setting pre-stroke other | 2 participants | 1 participants | 1 participants |
| living setting pre-stroke private home | 101 participants | 50 participants | 51 participants |
| mental status (MMSE) | 28 points STANDARD_DEVIATION 0 | 28 points STANDARD_DEVIATION 0 | 28 points STANDARD_DEVIATION 0 |
| paretic side left hemiparesis | 66 participants | 29 participants | 37 participants |
| paretic side right hemiparesis | 37 participants | 22 participants | 15 participants |
| Sex: Female, Male Female | 49 Participants | 27 Participants | 22 Participants |
| Sex: Female, Male Male | 54 Participants | 24 Participants | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 52 | 0 / 51 |
| serious Total, serious adverse events | 0 / 52 | 0 / 51 |
Outcome results
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.
Time frame: baseline and 1 year
Population: those who completed 1 year testing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Subjective Index of Physical and Social Outcome (SIPSO) | baseline | 26.6 scores on a scale | Standard Deviation 1.1 |
| Control | Subjective Index of Physical and Social Outcome (SIPSO) | one year | 29.7 scores on a scale | Standard Deviation 0.8 |
| Intervention | Subjective Index of Physical and Social Outcome (SIPSO) | baseline | 26.8 scores on a scale | Standard Deviation 1.2 |
| Intervention | Subjective Index of Physical and Social Outcome (SIPSO) | one year | 30.1 scores on a scale | Standard Deviation 0.8 |
p-value: 0.44ANCOVA
Primary
Subjective Index of Physical Integration (Subscale of SIPSO)
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
Time frame: baseline and one year
Population: those who completed 1 year testing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Subjective Index of Physical Integration (Subscale of SIPSO) | Baseline | 12.9 points on a scale | Standard Deviation 0.7 |
| Control | Subjective Index of Physical Integration (Subscale of SIPSO) | One year | 15.2 points on a scale | Standard Deviation 0.4 |
| Intervention | Subjective Index of Physical Integration (Subscale of SIPSO) | Baseline | 12.8 points on a scale | Standard Deviation 0.8 |
| Intervention | Subjective Index of Physical Integration (Subscale of SIPSO) | One year | 15.4 points on a scale | Standard Deviation 0.4 |
p-value: 0.78ANCOVA
Primary
Subjective Index of Social Integration (Subscale of SIPSO)
see Subjective Index of Physical and Social Outcome (SIPSO) above
Time frame: baseline and one year
Population: those who completed 1 year testing
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Subjective Index of Social Integration (Subscale of SIPSO) | Baseline | 13.8 points on a scale | Standard Deviation 0.6 |
| Control | Subjective Index of Social Integration (Subscale of SIPSO) | One year | 14.4 points on a scale | Standard Deviation 0.5 |
| Intervention | Subjective Index of Social Integration (Subscale of SIPSO) | Baseline | 14.0 points on a scale | Standard Deviation 0.7 |
| Intervention | Subjective Index of Social Integration (Subscale of SIPSO) | One year | 14.7 points on a scale | Standard Deviation 0.7 |
p-value: 0.66ANCOVA
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.
Time frame: baseline and one year
Population: those enrolled at 1 year (primary endpoint)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Health-related Quality of Life - Mental | Baseline | 48.0 points | Standard Deviation 2 |
| Control | Health-related Quality of Life - Mental | One year | 52.8 points | Standard Deviation 1.3 |
| Intervention | Health-related Quality of Life - Mental | Baseline | 49.3 points | Standard Deviation 1.6 |
| Intervention | Health-related Quality of Life - Mental | One year | 51.2 points | Standard Deviation 1.4 |
p-value: 0.6ANCOVA
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.
Time frame: baseline and one year
Population: those enrolled at primary endpoint (one year)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Health-related Quality of Life - Physical | Baseline | 35.7 points | Standard Deviation 1.2 |
| Control | Health-related Quality of Life - Physical | One year | 42.0 points | Standard Deviation 1.1 |
| Intervention | Health-related Quality of Life - Physical | Baseline | 36.4 points | Standard Deviation 1.3 |
| Intervention | Health-related Quality of Life - Physical | One year | 40.3 points | Standard Deviation 1.2 |
p-value: 0.72ANCOVA
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)
Time frame: baseline and 1 year
Population: those still enrolled at primary endpoint (one year)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Mobility Function | Baseline | 23.1 seconds | Standard Deviation 3.4 |
| Control | Mobility Function | One year | 18.7 seconds | Standard Deviation 2 |
| Intervention | Mobility Function | Baseline | 19.9 seconds | Standard Deviation 3.4 |
| Intervention | Mobility Function | One year | 19.7 seconds | Standard Deviation 2 |
p-value: 0.83ANCOVA
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.
Time frame: baseline and 12 months
Population: all those enrolled at primary endpoint - 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control | Physical Capacity | Baseline | 258.9 meters | Standard Deviation 23.9 |
| Control | Physical Capacity | One year | 332.0 meters | Standard Deviation 19.2 |
| Intervention | Physical Capacity | Baseline | 285.1 meters | Standard Deviation 25.1 |
| Intervention | Physical Capacity | One year | 338.1 meters | Standard Deviation 20.2 |
Comparison: ANCOVA - comparing absolute measures and including baseline as co-variatep-value: 0.45ANCOVA