Trial Outcomes & Findings for Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis (NCT NCT00125658)

NCT ID: NCT00125658

Last Updated: 2017-06-23

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 14 participants
• Primary outcome timeframe: baseline, 10 weeks, 20 weeks
• Results posted on: 2017-06-23

Participant Flow

Participant milestones

Measure	Order A (FTP Prior to Power) Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).	Order B (Power Prior to FTP) Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).
Overall Study STARTED	8	6
Overall Study COMPLETED	8	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

Baseline characteristics by cohort

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	56.5 years STANDARD_DEVIATION 17.9 • n=5 Participants	64.2 years STANDARD_DEVIATION 9.8 • n=7 Participants	59.8 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	6 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Change in Trunk Displacement Treatment effect (10 wks)	3.79 centimeters Standard Deviation 0.97	-3.62 centimeters Standard Deviation 1.81
Change in Trunk Displacement Order effect (20 wks)	0.66 centimeters Standard Deviation 2.44	-4.76 centimeters Standard Deviation 2.82

PRIMARY outcome

Timeframe: baseline, 10 weeks, 20 weeks

joint range of motion obtained using kinematics / motion capture. Change scores expressed relative to baseline.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Change in Shoulder Flexion Order effect (20 wks)	-1.61 degrees Standard Deviation 10.81	10.37 degrees Standard Deviation 9.51
Change in Shoulder Flexion Treatment effect (10 wks)	-2.42 degrees Standard Deviation 10.44	11.88 degrees Standard Deviation 7.78

PRIMARY outcome

Timeframe: baseline, 10 weeks, 20 weeks

joint range of motion obtained using kinematics / motion capture. Change scores are expressed relative to baseline.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Change in Elbow Extension Range of Motion Treatment effect (10 wks)	-8.83 degrees Standard Deviation 11.3	22.52 degrees Standard Deviation 20.3
Change in Elbow Extension Range of Motion Order effect (20 wks)	-5.62 degrees Standard Deviation 11.64	26.20 degrees Standard Deviation 30.58

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Upper-extremity Fugl-Meyer Motor Assessment Treatment effect (10 wks)	7.0 units on a scale Standard Deviation 9.1	6.7 units on a scale Standard Deviation 4.4
Upper-extremity Fugl-Meyer Motor Assessment Order effect (20 wks)	10.14 units on a scale Standard Deviation 4.34	9.00 units on a scale Standard Deviation 5.80

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Movement Speed Order effect (20 wks)	1.46 cm/s Standard Deviation 7.20	7.15 cm/s Standard Deviation 7.28
Movement Speed Treatment effect (10 wks)	3.86 cm/s Standard Deviation 4.21	-2.67 cm/s Standard Deviation 6.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Movement Accuracy (Reach Path Ratio, RPR) Treatment effect (10 wks)	-0.22 ratio Standard Deviation 1.70	-1.82 ratio Standard Deviation 1.38
Movement Accuracy (Reach Path Ratio, RPR) Order effect (20 wks)	-0.85 ratio Standard Deviation 1.72	-1.59 ratio Standard Deviation 1.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Order A n=8 Participants 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.	Order B n=6 Participants 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.
Movement Smoothness Treatment effect (10 wks)	0.71 sub movements Standard Deviation 4.43	-2.79 sub movements Standard Deviation 1.38
Movement Smoothness Order effect (20 wks)	-1.64 sub movements Standard Deviation 10.81	-2.71 sub movements Standard Deviation 2.40

Adverse Events

Order A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Order B

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

Dr. Carolynn Patten

VA Brain Rehabilitation Research Center

Phone: 352.376.1611

Email: carolynn.patten@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place