Trial · NCT00465738
Registered outcomes43
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 43
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Responder in Disability Assessment Scale (DAS) at Week 4 - Per Protocol Set | At week 4 | The primary efficacy endpoint is the number of responder at Week 4; response defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit to Week 4. The DAS determines the functional impairment for the domains hygiene, dressing, limb position and pain according to the following scale: 0 = no disability; 1 = mild disability; 2 = moderate disability; 3 = severe disability. At Screening visit, the subject and investigator, selected together one of the four domains as the primary therapeutic target. |
| Secondary | Responder in DAS at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in DAS at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in DAS at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement (reduction) of at least one point in the DAS for the primary therapeutic target from baseline visit. |
| Secondary | Responder in Frenchay Arm Test (FAT) at Week 4 - Full Analysis Set | Week 4 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in FAT at Week 12 - Full Analysis Set | Week 12 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in FAT at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement (increase) of at least one point in the FAT from baseline visit. For the FAT the investigator assessed the extent of functionality of the upper limb according to five standardized tests. Each test is rated with 0 = failed or 1 = successfully passed. For the evaluation, the sum of all test scores was calculated resulting in a total score from 0 to 5. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. The Ashworth Scale is a 5-point-scale to rate to degree of spasticity: 0 = No increase in tone; 1 = Slight increase in tone giving a "catch" when the limb was moved in flexion or extension; 2 = More marked increase in tone, but limb easily flexed; 3 = Considerable increase in tone - passive movements difficult; 4 = Limb rigid in flexion or extension. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Elbow Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Wrist Flexors) at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Wrist Flexors) at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Wrist Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Thumb Flexors) at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Thumb Flexors) at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Thumb Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Fingers Flexors) at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Fingers Flexors) at Week 12 - Full Analysis Set | week 12 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Fingers Flexors) at Follow up - Full Analysis Set | follow up visit, between week 12 and week 20 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
| Secondary | Responder in Ashworth Scale (Forearm Pronators) at Week 4 - Full Analysis Set | week 4 | Response is defined as an improvement of at least one point in the Ashworth Scale for the treated muscle group from baseline visit. |
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.
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GET https://conductscience.org/api/trials/v1/NCT00465738/registered