Cerebrovascular Accident
Conditions
Keywords
biomechanics, Cerebrovascular Accident, electromyography, muscular weakness, recovery of function, reflex variability stroke, upper-extremity kinematics
Brief summary
The results of this study will provide sound, scientific evidence of physiologic mechanisms responsible for upper-extremity weakness; evidence of the processes involved in neuromuscular adaptation; and will elucidate the relationship between impairment and motor disability in post-stroke hemiparesis.
Detailed description
This proposal extends the work accomplished in our initial study (project #B2405R, 'Effects of Strength Training on Upper-limb Function in Post-stroke Hemiparesis'). In the present study we will conduct a double-blind, randomized clinical trial of staged rehabilitation for the upper-extremity involving sequential delivery of functional therapy and high intensity resistance training. Therefore, this proposal directly compares the effects of functional and resistance training delivered individually. The researchers' previous work investigated a hybrid therapy of functional and resistance training against functional training alone. All subjects will participate in a 5 week run-in period of no treatment. This no-treatment block will afford multiple baseline measurements and, in addition, will provide information regarding the rate and magnitude of any spontaneous recovery without treatment. Following the second baseline measurement, all subjects will be randomized to upper-extremity rehabilitation in either: Order A - 10 weeks of functional task practice training (FTP) followed by 10 weeks of high-intensity resistance training (Power) or Order B - resistance training (Power) followed by FTP. Re-evaluation will occur following each block of treatment,and retention effects will be evaluated after 6 and 12 months with no additional treatment. Subjects will be evaluated with: outcome measures used broadly in Clinical Neurology and Rehabilitation, a battery of biomechanical performance measures including: strength, muscle activation, reflex modulation, and motor coordination, and with kinematics of free reaching movements. The researchers will investigate persons in the intermediate phase of recovery which they define as between 6 and 18 months post-stroke , having completed all inpatient and outpatient therapies, with remaining residual motor deficits.
Interventions
OTHERControl
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Functional Task Practice (FTP) followed by 10 weeks of Power training (dynamic resistance exercise). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
OTHERExperimental
Following an initial testing session, you will complete a 5 week no training period. At the end of this period you will then participate in a 20 week therapy program - 10 weeks of Power training (dynamic resistance exercise) followed by 10 weeks of Functional Task Practice (FTP). Each 10 week block has 30 therapy sessions for a total of 60 sessions, each lasting approximately 1-1/2 hours. Follow up evaluations will be scheduled at 6 months and 12 months after completion of the entire 20 week therapy program.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Clinical diagnosis of cerebrovascular accident * Single event * Unilateral hemiplegia * Between 6 months and 18 months post-event * Impairment of upper-extremity function * Ability to produce partial range of motion out of plane of gravity at shoulder, elbow, and wrist * At least 10 degrees of wrist motion (any 10 degrees), and finger flexion/extension in 2 fingers * Cognitive ability to follow 3-step commands
Exclusion criteria
* Unstable or uncontrolled blood pressure * Uncontrolled seizures * Flaccid hemiplegia * Severe cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Trunk Displacement | baseline, 10 weeks, 20 weeks | Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline. |
| Change in Shoulder Flexion | baseline, 10 weeks, 20 weeks | joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline. |
| Change in Elbow Extension Range of Motion | baseline, 10 weeks, 20 weeks | joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline. |
| Upper-extremity Fugl-Meyer Motor Assessment | baseline, 10 weeks, 20 weeks | The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Movement Accuracy (Reach Path Ratio, RPR) | baseline, 10 weeks, 20 weeks | Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline. |
| Movement Smoothness | baseline, 10 weeks, 20 weeks | Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or jerky movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline. |
| Movement Speed | baseline, 10 weeks, 20 weeks | peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Order A Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Single, unilateral stroke, \>6 \<26 months post-event. | 8 |
| Order B Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Single, unilateral stroke, \>6 \<26 months post-event. | 6 |
| Total | 14 |
Baseline characteristics
| Characteristic | Order B | Order A | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Age, Continuous | 64.2 years STANDARD_DEVIATION 9.8 | 56.5 years STANDARD_DEVIATION 17.9 | 59.8 years STANDARD_DEVIATION 15 |
| Region of Enrollment United States | 6 participants | 8 participants | 14 participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 8 | 0 / 6 |
Outcome results
Primary
Change in Elbow Extension Range of Motion
joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Change in Elbow Extension Range of Motion | Treatment effect (10 wks) | -8.83 degrees | Standard Deviation 11.3 |
| Order A | Change in Elbow Extension Range of Motion | Order effect (20 wks) | -5.62 degrees | Standard Deviation 11.64 |
| Order B | Change in Elbow Extension Range of Motion | Order effect (20 wks) | 26.20 degrees | Standard Deviation 30.58 |
| Order B | Change in Elbow Extension Range of Motion | Treatment effect (10 wks) | 22.52 degrees | Standard Deviation 20.3 |
Comparison: Compares FTP vs POWER by comparing the change in elbow extension range of motion between the end of treatment block 1 (10 weeks) and baseline.p-value: 0.004t-test, 2 sided
Comparison: Tests for the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP) by comparing the change in elbow extension range of motion between the end of overall treatment (20 weeks) and baseline.p-value: 0.034t-test, 2 sided
Primary
Change in Shoulder Flexion
joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Change in Shoulder Flexion | Treatment effect (10 wks) | -2.42 degrees | Standard Deviation 10.44 |
| Order A | Change in Shoulder Flexion | Order effect (20 wks) | -1.61 degrees | Standard Deviation 10.81 |
| Order B | Change in Shoulder Flexion | Treatment effect (10 wks) | 11.88 degrees | Standard Deviation 7.78 |
| Order B | Change in Shoulder Flexion | Order effect (20 wks) | 10.37 degrees | Standard Deviation 9.51 |
Comparison: Tests effect of FTP vs. Power. The change in shoulder flexion range of motion was compared between baseline and the end of treatment Block 1 (i.e., 10 weeks).p-value: 0.13t-test, 2 sided
Comparison: Test the effect of treatment order OrderA (FTP before POWER) vs. OrderB (POWER before FTP). The change in shoulder flexion range of motion was compared between the end of treatment (20 weeks) and baseline.p-value: 0.048t-test, 2 sided
Primary
Change in Trunk Displacement
Distance (in cm) of trunk lean while performing reach-to-grasp. This information is obtained from kinematics/3D motion capture and is used to inform regarding compensatory use of the trunk as compared to active motion of the shoulder, elbow, wrist, and hand, during reach-to-grasp. Change scores are expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Change in Trunk Displacement | Treatment effect (10 wks) | 3.79 centimeters | Standard Deviation 0.97 |
| Order A | Change in Trunk Displacement | Order effect (20 wks) | 0.66 centimeters | Standard Deviation 2.44 |
| Order B | Change in Trunk Displacement | Treatment effect (10 wks) | -3.62 centimeters | Standard Deviation 1.81 |
| Order B | Change in Trunk Displacement | Order effect (20 wks) | -4.76 centimeters | Standard Deviation 2.82 |
Comparison: Primary Comparison (i.e., FTP vs. POWER) Data are reported as change scores, between the end of treatment block 1(10 weeks) and baseline; thus, this analysis directly compares FTP vs. Power. A negative value represents improvement (i.e., reduced trunk displacement) while a positive value represents an increase in compensatory trunk movement.p-value: <0.001t-test, 2 sided
Comparison: Order effect, testing OrderA (FTP before POWER) vs. OrderB (POWER before FTP). Change scores for trunk displacement at the end of both treatment blocks (20 weeks) relative to baseline (e.g., 20 weeks - baseline) were compared between OrderA and OrderB.p-value: 0.002t-test, 2 sided
Primary
Upper-extremity Fugl-Meyer Motor Assessment
The Fugl-Meyer Motor Assessment is a standardized scale used to measure the magnitude of motor impairment (severity) following stroke. There are separate sub-scales for the upper and lower extremities. Here we used the upper-extremity component; the full range of the scale is 0 - 66 points. Higher scores approaching 66 represent better, and lower scores approaching 0 worse, motor function. There is a significant ceiling effect with the FMA, thus a score of 66 points does not mean an individual with stroke has fully recovered. Data are change scores expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Upper-extremity Fugl-Meyer Motor Assessment | Treatment effect (10 wks) | 7.0 units on a scale | Standard Deviation 9.1 |
| Order A | Upper-extremity Fugl-Meyer Motor Assessment | Order effect (20 wks) | 10.14 units on a scale | Standard Deviation 4.34 |
| Order B | Upper-extremity Fugl-Meyer Motor Assessment | Treatment effect (10 wks) | 6.7 units on a scale | Standard Deviation 4.4 |
| Order B | Upper-extremity Fugl-Meyer Motor Assessment | Order effect (20 wks) | 9.00 units on a scale | Standard Deviation 5.8 |
Comparison: Tests the effects of FTP vs. POWER on motor impairment (UE FMA) by comparing the change in FMA between the end of treatment block 1 (10 weeks) and baseline.p-value: 0.564Wilcoxon (Mann-Whitney)
Comparison: Tests for an effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in UE FMA between the end of treatment (20 weeks) and baseline.p-value: 0.948Wilcoxon (Mann-Whitney)
Secondary
Movement Accuracy (Reach Path Ratio, RPR)
Measure is derived from kinematics/motion analysis. RPR = ratio of actual reach trajectory relative to an idealized straight line. Data are change scores, expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Movement Accuracy (Reach Path Ratio, RPR) | Treatment effect (10 wks) | -0.22 ratio | Standard Deviation 1.7 |
| Order A | Movement Accuracy (Reach Path Ratio, RPR) | Order effect (20 wks) | -0.85 ratio | Standard Deviation 1.72 |
| Order B | Movement Accuracy (Reach Path Ratio, RPR) | Treatment effect (10 wks) | -1.82 ratio | Standard Deviation 1.38 |
| Order B | Movement Accuracy (Reach Path Ratio, RPR) | Order effect (20 wks) | -1.59 ratio | Standard Deviation 1.43 |
Comparison: Tests for differences in FTP vs. POWER by comparing the change in RPR between the end of treatment block 1 (10 weeks) and baseline.p-value: 0.078t-test, 2 sided
Comparison: Tests the effect of treatment order (Order A (FTP \> POWER) vs. Order B (POWER \> FTP)) by comparing the change in RPR between the end of overall treatment (20 weeks) and baseline.p-value: 0.4t-test, 2 sided
Secondary
Movement Smoothness
Movement smoothness is determined by assessing the number of sub movements (i.e., starts and stops) that can be identified during performance of a task. Here the task was reach-to-grasp. Sub movement are identified from kinematics/3D motion analysis. Sub-movements represent discontinuities or jerky movements. For example, skilled reaching is smooth and may reveal a single movement unit; in contrast, unskilled movements will reveal multiple movement units (i.e., starts and stops). As a performer practices and learns the movement, the number of sub movements is reduced. Sub movements can also present in persons with pathology. The unit of sub movements is whole numbers, or counts, of the sub movements. Data are change scores, expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Movement Smoothness | Treatment effect (10 wks) | 0.71 sub movements | Standard Deviation 4.43 |
| Order A | Movement Smoothness | Order effect (20 wks) | -1.64 sub movements | Standard Deviation 10.81 |
| Order B | Movement Smoothness | Treatment effect (10 wks) | -2.79 sub movements | Standard Deviation 1.38 |
| Order B | Movement Smoothness | Order effect (20 wks) | -2.71 sub movements | Standard Deviation 2.4 |
Comparison: Tests for the effect of treatment (FTP vs. POWER) by comparing the change in movement smoothness between the end of treatment block 1 (10 weeks) and baseline.p-value: 0.085t-test, 2 sided
Comparison: Tests for the effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP)) by comparing the change in movement smoothness between the end of overall treatment (20 weeks) and baseline.p-value: 0.635t-test, 2 sided
Secondary
Movement Speed
peak velocity of movement (cm/s) during reach-to-grasp, obtained using kinematics/motion capture. Data are change scores expressed relative to baseline.
Time frame: baseline, 10 weeks, 20 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Order A | Movement Speed | Treatment effect (10 wks) | 3.86 cm/s | Standard Deviation 4.21 |
| Order A | Movement Speed | Order effect (20 wks) | 1.46 cm/s | Standard Deviation 7.2 |
| Order B | Movement Speed | Treatment effect (10 wks) | -2.67 cm/s | Standard Deviation 6.99 |
| Order B | Movement Speed | Order effect (20 wks) | 7.15 cm/s | Standard Deviation 7.28 |
Comparison: Tests for differences between FTP vs. POWER by comparing the change in movement speed between the end of treatment block 1 (10 weeks) and baseline.p-value: 0.056t-test, 2 sided
Comparison: Tests for effect of treatment order (OrderA (FTP before POWER) vs. OrderB (POWER before FTP))by comparing the change in movement speed between the end of overall treatment (20 weeks) and baseline.p-value: 0.168t-test, 2 sided