Trial · NCT01032239
SISTERS: Spasticity In Stroke Study - Randomized Study
NCT01032239, Phase 4, Completed, MedtronicNeuro; results first posted 2018-02-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. SISTERS: Spasticity In Stroke Study - Randomized Study. Trials, record NCT01032239. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01032239
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SISTERS: Spasticity In Stroke Study - Randomized Study
- NCT number
- NCT01032239
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 61 participants, actual
- Lead sponsor
- MedtronicNeuro
- Conditions
- Severe Spasticity
- Interventions
- intrathecal baclofen
- First posted
- 2009-12-15
- Last updated
- 2018-02-15
- Results first posted
- 2018-02-15
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | Baseline and month 6 | 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 average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. |
| Secondary | Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | Baseline and month 6 | 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 upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. |
| Secondary | Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | Baseline and month 6 | FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline. |
| Secondary | Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | Baseline and month 6 | Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline |
| Secondary | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | baseline, month 3, month 6 | Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated. |
| Secondary | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Baseline and month 6 | NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is "no pain" while a score of 10 (ten) is "worst possible pain". Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline. |
| Secondary | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | month 6 | GAS is designed to measure the achievement of treatment goals using the following 6 levels of achievement: worse than start (-3), much less than expected (-2), somewhat less than expected (-1), as expected (0), somewhat more than expected (+1), much more than expected (+2). The primary therapy goal and the criteria for the levels of achievement was defined by the medical team together with the patient and his/her family/legal representative/caregiver at the first day of the study. The number and percentage of patients who achieved the therapeutic goal at Month 6 was compared between the ITB and BMT arm. |
| Secondary | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | Baseline and month 6 | The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: "no health problems", "moderate health problems", and "severe health problems". Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score. |
| Secondary | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | Baseline and month 6 | The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline. |
| Secondary | Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | Baseline and month 6 | SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed. Change=SS-QoL score at month 6 - SS-QoL score at baseline. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
| SECONDARY | Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
| SECONDARY | Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
| SECONDARY | Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.Only High level functional patients (HLP) were analyzed. HLP were defined as patients able to transfer from the wheelchair to bed without human assistance. | seconds | MEAN |
| SECONDARY | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | baseline, month 3, month 6 | Intent to treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
| SECONDARY | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | month 6 | Intent to treat analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
| SECONDARY | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.~SF-12 assessment has been introduced later in a second version of the protocol, hence the lower number of patients. | units on a scale | MEAN |
| SECONDARY | Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | Baseline and month 6 | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | ITB Therapy | -0.99 | Standard Deviation 0.75 | units on a scale | |
| Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | Best Medical Treatment (BMT) | -0.43 | Standard Deviation 0.72 | units on a scale | |
| Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | ITB Therapy | -0.66 | Standard Deviation 0.59 | units on a scale | |
| Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | Best Medical Treatment (BMT) | -0.17 | Standard Deviation 0.70 | units on a scale | |
| Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | ITB Therapy | 2.68 | Standard Deviation 10.31 | units on a scale | |
| Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | Best Medical Treatment (BMT) | -2.58 | Standard Deviation 11.00 | units on a scale | |
| Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | ITB Therapy | 4.86 | Standard Deviation 59.82 | seconds | |
| Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | Best Medical Treatment (BMT) | -2.48 | Standard Deviation 65.60 | seconds | |
| Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | ITB Therapy | Baseline / HLP | 22 | Participants | |
| Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Best Medical Treatment (BMT) | Baseline / HLP | 24 | Participants |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ITB Therapy | 31 | |
| Overall Study | STARTED | Best Medical Treatment (BMT) | 29 | |
| Overall Study | Implant | ITB Therapy | 25 | |
| Overall Study | Implant | Best Medical Treatment (BMT) | 0 | |
| Overall Study | COMPLETED | ITB Therapy | 24 | |
| Overall Study | COMPLETED | Best Medical Treatment (BMT) | 24 | |
| Overall Study | NOT COMPLETED | ITB Therapy | 7 | |
| Overall Study | NOT COMPLETED | Best Medical Treatment (BMT) | 5 |
Source ClinicalTrials.gov
Adverse events284
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cerumen impaction | Ear and labyrinth disorders | ITB-I | 2 | 25 | 2 |
| other | Cerumen impaction | Ear and labyrinth disorders | BMT+ITB-NI | 0 | 35 | 0 |
| other | Tinnitus | Ear and labyrinth disorders | ITB-I | 1 | 25 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | BMT+ITB-NI | 0 | 35 | 0 |
| other | Vertigo | Ear and labyrinth disorders | ITB-I | 0 | 25 | 0 |
| other | Vertigo | Ear and labyrinth disorders | BMT+ITB-NI | 1 | 35 | 1 |
| other | Cataract | Eye disorders | ITB-I | 1 | 25 | 2 |
| other | Cataract | Eye disorders | BMT+ITB-NI | 0 | 35 | 0 |
| other | Conjunctivitis | Eye disorders | ITB-I | 1 | 25 | 1 |
| other | Conjunctivitis | Eye disorders | BMT+ITB-NI | 0 | 35 | 0 |
1 to 10 of 284Source ClinicalTrials.gov
See all 284 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ITB-I | 1 | 25 |
| Total, all-cause mortality | BMT+ITB-NI | 0 | 35 |
| Total, other adverse events | ITB-I | 23 | 25 |
| Total, other adverse events | BMT+ITB-NI | 21 | 35 |
| Total, serious adverse events | ITB-I | 12 | 25 |
| Total, serious adverse events | BMT+ITB-NI | 10 | 35 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ITB-I vs BMT+ITB-NI: deaths from any cause | Trial comparisons |
| ITB-I vs BMT+ITB-NI: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
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