Trial Outcomes & Findings for Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke? (NCT NCT00400712)
NCT ID: NCT00400712
Last Updated: 2016-05-05
Results Overview
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.
COMPLETED
NA
103 participants
baseline and 1 year
2016-05-05
Participant Flow
Participant milestones
| Measure |
Control
no intervention, natural history following stroke
|
Intervention
two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
| Measure |
Control
no intervention, natural history following stroke
|
Intervention
two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
12
|
|
Overall Study
Physician Decision
|
5
|
4
|
Baseline Characteristics
Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?
Baseline characteristics by cohort
| Measure |
Control
n=52 Participants
natural progression post-stroke
|
Intervention
n=51 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
Total
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 1.7 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Admission Functional Independence
|
96.2 units on a scale
STANDARD_DEVIATION 23.4 • n=5 Participants
|
100.5 units on a scale
STANDARD_DEVIATION 22.1 • n=7 Participants
|
98.4 units on a scale
STANDARD_DEVIATION 22.7 • n=5 Participants
|
|
Balance ability
|
45.4 units on a scale
STANDARD_DEVIATION 13.5 • n=5 Participants
|
47.8 units on a scale
STANDARD_DEVIATION 11.9 • n=7 Participants
|
46.6 units on a scale
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
living setting pre-stroke
private home
|
51 participants
n=5 Participants
|
50 participants
n=7 Participants
|
101 participants
n=5 Participants
|
|
living setting pre-stroke
other
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
mental status (MMSE)
|
28 points
STANDARD_DEVIATION 0 • n=5 Participants
|
28 points
STANDARD_DEVIATION 0 • n=7 Participants
|
28 points
STANDARD_DEVIATION 0 • n=5 Participants
|
|
paretic side
left hemiparesis
|
37 participants
n=5 Participants
|
29 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
paretic side
right hemiparesis
|
15 participants
n=5 Participants
|
22 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 1 yearPopulation: those who completed 1 year testing
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.
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Subjective Index of Physical and Social Outcome (SIPSO)
baseline
|
26.6 scores on a scale
Standard Deviation 1.1
|
26.8 scores on a scale
Standard Deviation 1.2
|
|
Subjective Index of Physical and Social Outcome (SIPSO)
one year
|
29.7 scores on a scale
Standard Deviation 0.8
|
30.1 scores on a scale
Standard Deviation 0.8
|
PRIMARY outcome
Timeframe: baseline and one yearPopulation: those who completed 1 year testing
see Subjective Index of Physical and Social Outcome (SIPSO) above
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Subjective Index of Social Integration (Subscale of SIPSO)
Baseline
|
13.8 points on a scale
Standard Deviation 0.6
|
14.0 points on a scale
Standard Deviation 0.7
|
|
Subjective Index of Social Integration (Subscale of SIPSO)
One year
|
14.4 points on a scale
Standard Deviation 0.5
|
14.7 points on a scale
Standard Deviation 0.7
|
PRIMARY outcome
Timeframe: baseline and one yearPopulation: those who completed 1 year testing
see 'Subjective Index of Physical and Social Outcome (SIPSO) above
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Subjective Index of Physical Integration (Subscale of SIPSO)
Baseline
|
12.9 points on a scale
Standard Deviation 0.7
|
12.8 points on a scale
Standard Deviation 0.8
|
|
Subjective Index of Physical Integration (Subscale of SIPSO)
One year
|
15.2 points on a scale
Standard Deviation 0.4
|
15.4 points on a scale
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: baseline and 1 yearPopulation: those still enrolled at primary endpoint (one 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)
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Mobility Function
Baseline
|
23.1 seconds
Standard Deviation 3.4
|
19.9 seconds
Standard Deviation 3.4
|
|
Mobility Function
One year
|
18.7 seconds
Standard Deviation 2.0
|
19.7 seconds
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: all those enrolled at primary endpoint - 1 year
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.
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Physical Capacity
Baseline
|
258.9 meters
Standard Deviation 23.9
|
285.1 meters
Standard Deviation 25.1
|
|
Physical Capacity
One year
|
332.0 meters
Standard Deviation 19.2
|
338.1 meters
Standard Deviation 20.2
|
SECONDARY outcome
Timeframe: baseline and one yearPopulation: those enrolled at primary endpoint (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.
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Health-related Quality of Life - Physical
Baseline
|
35.7 points
Standard Deviation 1.2
|
36.4 points
Standard Deviation 1.3
|
|
Health-related Quality of Life - Physical
One year
|
42.0 points
Standard Deviation 1.1
|
40.3 points
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baseline and one yearPopulation: those enrolled at 1 year (primary endpoint)
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.
Outcome measures
| Measure |
Control
n=35 Participants
natural progression post-stroke
|
Intervention
n=35 Participants
two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)
physical rehabilitation: two weeks intensive physical rehabilitation
|
|---|---|---|
|
Health-related Quality of Life - Mental
Baseline
|
48.0 points
Standard Deviation 2.0
|
49.3 points
Standard Deviation 1.6
|
|
Health-related Quality of Life - Mental
One year
|
52.8 points
Standard Deviation 1.3
|
51.2 points
Standard Deviation 1.4
|
Adverse Events
Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place