Trial · NCT03172026
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in 10 Meter Walk Test | Baseline, 6 months post | Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints. |
| Primary | Change in Action Research Arm Test | Baseline, 6 months post | Assessment of upper extremity function. Our sample size of 30 for each group is based on a statistical power of 80% with an alpha of 5% for detecting a meaningful difference of 6 points, i.e., a 10% change, which has been suggested by several completed trials. In a stroke trial, the standard deviation was 8 points measured at 2 weeks post stroke. |
| Secondary | Change in Fugl-Meyer Motor Score | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Assessment of arm and leg impairment after stroke |
| Secondary | Change in Stroke Impact Scale | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Self-report questionnaire on quality of life post-stroke |
| Secondary | Change in 6 Minute Walking Distance | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Distance walked in a 6 minute time period |
| Secondary | Change in Physical Activity Enjoyment Scale | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Self-report questionnaire related to exercise enjoyment |
| Secondary | Change in Activity Self Efficacy | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Self-report questionnaire related to confidence in increasing activity and maintaining exercise routines |
| Secondary | Change in International Physical Activity Questionnaire | Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke | Self-report of activity levels |
| Secondary | Change From Baseline in Walking Activity, Sensors | Collected daily for 8 weeks | Sedentary time |
| Secondary | Upper Extremity Practice, Sensors | Collected daily for 8 weeks | Amount of time practicing |
| Secondary | Upper Extremity Practice, Sensors | Collected daily for 8 weeks | Repetitions of task practice |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT03172026/registered