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NCT01032239 · ClinicalTrials.gov registry record · Phase 4
SISTERS: Spasticity In Stroke Study - Randomized Study
A Phase 4 study, sponsored by MedtronicNeuro.
- Completed
- Registry status
- Phase 4
- Development phase
- 61
- Enrollment target
NCT01032239: Completed Phase 4 study, sponsored by MedtronicNeuro.
NCT01032239 is a Phase 4 study that has completed, run by MedtronicNeuro. The registered enrollment target is 61 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032239, a Phase 4 study, has completed, sponsored by MedtronicNeuro.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 61 participants
- Enrollment target
Study Summary
To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
Primary Outcome
AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in a
Interventions
- DRUG intrathecal baclofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2009-11 |
| Est. Completion | 2016-09 |
| Phase | Phase 4 |
What the finished NCT01032239 record still lists
NCT01032239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which intrathecal baclofen is the first listed.
NCT01032239 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01032239 about?
NCT01032239 is a clinical study titled "SISTERS: Spasticity In Stroke Study - Randomized Study". To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions a...
What is the current status of trial NCT01032239?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 61 participants. The study started on 2009-11. Estimated completion is 2016-09.
What interventions are being tested in trial NCT01032239?
The interventions under investigation include: intrathecal baclofen (DRUG).
Who is sponsoring clinical trial NCT01032239?
This trial is sponsored by MedtronicNeuro, which has 51 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01032239's enrollment target sits among peer trials
61 1119th of 2000 higher than 876 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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