Trial Outcomes & Findings for Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine (NCT NCT00720759)
NCT ID: NCT00720759
Last Updated: 2014-03-07
Results Overview
The Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
3 months after completion of treatment
Results posted on
2014-03-07
Participant Flow
Subjects were recruited between 1/5/10 and 6/3/11. Recruitment sites included: 1) The VA Rehabilitation Research and Development Brain Rehabilitation Research Center of Excellence at the Malcom Randall VA Medical Center, Gainesville, Florida; and outpatient clinics of the Brooks Rehabilitation Hospital, Jacksonville, Florida.
All potential participants who met inclusion and exclusion criteria for the study and who provided informed consent were promptly randomized and entered into the study.
Participant milestones
| Measure |
Arm 1
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Arm 1
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Improving Stroke Rehabilitation: Spacing Effect and D-cycloserine
Baseline characteristics by cohort
| Measure |
Arm 1
n=6 Participants
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
n=6 Participants
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
n=6 Participants
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
n=6 Participants
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
Total
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
60.33 years
STANDARD_DEVIATION 6.71 • n=5 Participants
|
57.83 years
STANDARD_DEVIATION 4.40 • n=7 Participants
|
56.50 years
STANDARD_DEVIATION 12.31 • n=5 Participants
|
58.17 years
STANDARD_DEVIATION 11.63 • n=4 Participants
|
58.2 years
STANDARD_DEVIATION 8.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
24 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 3 months after completion of treatmentThe Wolf Motor Function Test (time) score is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task. Score range on the WMFT-T is 0-120, lower scores being better.
Outcome measures
| Measure |
Arm 1
n=6 Participants
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
n=6 Participants
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
n=6 Participants
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
n=6 Participants
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
|---|---|---|---|---|
|
Wolf Motor Function Test (Time)
|
10.21 units on a scale
Standard Deviation 14.26
|
29.69 units on a scale
Standard Deviation 39.06
|
19.09 units on a scale
Standard Deviation 32.55
|
26.05 units on a scale
Standard Deviation 31.03
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 3
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm 4
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=6 participants at risk
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
n=6 participants at risk
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
n=6 participants at risk
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
n=6 participants at risk
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
|---|---|---|---|---|
|
Nervous system disorders
Recurrent stroke
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
Other adverse events
| Measure |
Arm 1
n=6 participants at risk
D-cycloserine + distributed treatment
D-cycloserine + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 2
n=6 participants at risk
D-cycloserine + condensed treatment
D-cycloserine + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with d-cycloserine 50 mg PO administered before each treatment session
|
Arm 3
n=6 participants at risk
Placebo + distributed treatment
Placebo + distributed treatment : Subjects will receive CIMT 2 hours/day, 3 days a week, for 10 weeks, in conjunction with placebo administered before each treatment session
|
Arm 4
n=6 participants at risk
Placebo + condensed treatment
Placebo + condensed treatment : Subjects will receive CIMT 6 hours/day, 5 days a week, for 2 weeks, in conjunction with placebo administered before each treatment session
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
skin tear
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
|
Nervous system disorders
insomnia
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
0.00%
0/6 • Adverse event data were collected from trial entry through 3 months following treatment completion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place