Trial Outcomes & Findings for Examining Rehabilitation Training Methods (NCT NCT02766400)
NCT ID: NCT02766400
Last Updated: 2020-01-09
Results Overview
Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
Baseline, rehab discharge, month 3, month 6, month 12
Results posted on
2020-01-09
Participant Flow
Recruitment period: August 2012 to December 2014. Participants with acute stroke were enrolled in inpatient rehabilitation at Mercy and Montefiore Hospital.
Excluded (n=27) * Insufficient cognitive impairment (n=6) * Mood/psychotic disorder (n=14) * Drug/alcohol abuse (n=3) * Change in medical status (n=1) * Pre-morbid cognitive impairment (n=1) * Short Length of Stay (n=2) Withdrew prior to randomization (n=7) * Changed mind (n=4) * Discharged (n=3)
Participant milestones
| Measure |
Guided Training
Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training
|
Directed Training
Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
22
|
|
Overall Study
COMPLETED
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Guided Training
Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training
|
Directed Training
Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Examining Rehabilitation Training Methods
Baseline characteristics by cohort
| Measure |
Guided Training
n=21 Participants
Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training
|
Directed Training
n=22 Participants
Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.86 years
STANDARD_DEVIATION 11.67 • n=5 Participants
|
66.73 years
STANDARD_DEVIATION 14.25 • n=7 Participants
|
66.30 years
STANDARD_DEVIATION 12.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
22 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Stroke onset
|
16.29 days
STANDARD_DEVIATION 18.24 • n=5 Participants
|
22.36 days
STANDARD_DEVIATION 30.97 • n=7 Participants
|
19.40 days
STANDARD_DEVIATION 25.46 • n=5 Participants
|
|
Stroke type
ischemic
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Stroke type
hemorrhagic
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Hemisphere
Left
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Hemisphere
Right
|
11 participants
n=5 Participants
|
9 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Stroke severity, NIHSS
|
7.00 units on a scale
STANDARD_DEVIATION 3.90 • n=5 Participants
|
7.86 units on a scale
STANDARD_DEVIATION 5.10 • n=7 Participants
|
7.44 units on a scale
STANDARD_DEVIATION 4.52 • n=5 Participants
|
|
Cognitive status, EXIT
|
12.38 units on a scale
STANDARD_DEVIATION 5.11 • n=5 Participants
|
10.86 units on a scale
STANDARD_DEVIATION 5.14 • n=7 Participants
|
11.60 units on a scale
STANDARD_DEVIATION 5.12 • n=5 Participants
|
|
Functional Independence Measure
|
67.33 units on a scale
STANDARD_DEVIATION 14.72 • n=5 Participants
|
67.32 units on a scale
STANDARD_DEVIATION 18.33 • n=7 Participants
|
67.33 units on a scale
STANDARD_DEVIATION 16.47 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, rehab discharge, month 3, month 6, month 12Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.
Outcome measures
| Measure |
Guided Training
n=21 Participants
Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.
Guided Training
|
Directed Training
n=22 Participants
Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.
Directed Training
|
|---|---|---|
|
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Baseline Scores
|
67.33 units on a scale
Standard Error 3.21
|
67.32 units on a scale
Standard Error 3.91
|
|
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Discharge Scores
|
86.86 units on a scale
Standard Error 3.08
|
89.05 units on a scale
Standard Error 4.41
|
|
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Month 3 Scores
|
105.32 units on a scale
Standard Error 4.94
|
102.55 units on a scale
Standard Error 5.41
|
|
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Month 6 Scores
|
107.68 units on a scale
Standard Error 3.45
|
100.52 units on a scale
Standard Error 5.35
|
|
Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Month 12 Scores
|
108.47 units on a scale
Standard Error 4.34
|
100.25 units on a scale
Standard Error 5.12
|
Adverse Events
Guided Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Directed Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elizabeth R. Skidmore, PhD, OTR/L, FAOTA
University of Pittsburgh
Phone: (412) 383-6617
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place