Severe Spasticity
Conditions
Keywords
Severe spasticity in post-stroke patients
Brief 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.
Detailed description
This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions. In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms: 1. ITB Therapy arm; or 2. BMT arm The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial. The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial. The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy. During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the response of the patient. Patients fulfilling the test success criterium will be implanted with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into the 6 month active trial, which includes a 6 week titration phase, during which time oral antispastic medications must be gradually reduced with complete discontinuation by the end of the titration period. During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and secondary endpoint assessments will be performed by a blinded assessor. The total study duration is expected to be 60 months, including a 39 month enrollment period. The total duration per patient is approximately 7 months (approximately 1 month run-in period followed by 6 months active treatment).
Interventions
DRUGintrathecal baclofen
ITB test, implant, 6 months follow-up
Sponsors
MedtronicNeuro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment: 1. patient (or legal guardian) has been informed of the study procedures and has given written informed consent 2. patient experienced last stroke \> 6 months prior to enrollment 3. patient presents spasticity in at least 2 extremities 4. patient presents an Ashworth score ≥ 3 in a minimum of two of the affected muscle groups in the lower extremities 5. patient is eligible to receive ITB Therapy following the Adult Spasticity Algorithm. A patient does not reach his/her therapy goal with other treatment interventions 6. stable blood pressure: no change in hypertensive medication in last month (NOTE: ventriculoperitoneal shunts and valves can be present) 7. if female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study 8. patient/family is willing to comply with study protocol including attending the study visits
Exclusion criteria
To be eligible for inclusion in this study the patients must not meet any of the following criteria: 1. patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB Therapy management 2. patient has known hypersensitivity to baclofen 3. active systemic infection (NOTE: pressure sores are not a contraindication unless they are present near the implant sites) 4. presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device 5. uncontrolled refractory epilepsy 6. use of oral vitamin K antagonists, e.g. warfarin/coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin, aggrenox, fragmin, plavix, ticlid) for the period of ITB test and implant 7. patient is pregnant or breastfeeding 8. patient received a Botulinum toxin injection less than 4 months ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Therapy Satisfaction | month 6 | Patients were presented with two statements (I am satisfied with the reduction in spasticity provided by my treatment, and I would recommend this therapy to a friend). They agreed, disagreed or were neutral with the statements. |
| Healthcare Resource Utilization | baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6 | Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6 |
| 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. |
Countries
Austria, Belgium, Germany, Italy, Netherlands, Slovenia, Spain, United Kingdom, United States
Participant flow
Pre-assignment details
A total of 61 patients were enrolled. One patient did not meet the inclusion criteria (screening failure). 60 patients were then randomized into the study.
Participants by arm
| Arm | Count |
|---|---|
| ITB Therapy Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump) | 31 |
| Best Medical Treatment (BMT) Use one or a combination oral antispastic medication. | 29 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 3 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | ITB Therapy | Best Medical Treatment (BMT) | Total |
|---|---|---|---|
| Age, Continuous | 56.09 years STANDARD_DEVIATION 11.12 | 55.67 years STANDARD_DEVIATION 8.6 | 55.89 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized Other | 8 Participants | 6 Participants | 14 Participants |
| Race/Ethnicity, Customized White | 23 Participants | 23 Participants | 46 Participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 24 Participants | 18 Participants | 42 Participants |
| Time since stroke | 4.95 years STANDARD_DEVIATION 3.56 | 4.55 years STANDARD_DEVIATION 3.73 | 4.76 years STANDARD_DEVIATION 3.62 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 25 | 0 / 35 |
| other Total, other adverse events | 23 / 25 | 21 / 35 |
| serious Total, serious adverse events | 12 / 25 | 10 / 35 |
Outcome results
Primary
Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITB Therapy | Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | -0.99 units on a scale | Standard Deviation 0.75 |
| Best Medical Treatment (BMT) | Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | -0.43 units on a scale | Standard Deviation 0.72 |
Comparison: To test the null hypothesis the sample size needed was 44 evaluable patient (22 per arm) with a power of 80 %.p-value: 0.01495.1% CI: [-1, -0.1667]Wilcoxon (Mann-Whitney)
Secondary
Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6
Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline
Time frame: Baseline and month 6
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITB Therapy | Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | 4.86 seconds | Standard Deviation 59.82 |
| Best Medical Treatment (BMT) | Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | -2.48 seconds | Standard Deviation 65.6 |
p-value: 0.6256Wilcoxon (Mann-Whitney)
Secondary
Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITB Therapy | Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | -0.66 units on a scale | Standard Deviation 0.59 |
| Best Medical Treatment (BMT) | Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | -0.17 units on a scale | Standard Deviation 0.7 |
p-value: 0.004295% CI: [-1, -0.2]Wilcoxon (Mann-Whitney)
Secondary
Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ITB Therapy | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | Utility Score | 0.09 units on a scale | Standard Deviation 0.26 |
| ITB Therapy | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | VAS | 9.68 units on a scale | Standard Deviation 20.42 |
| Best Medical Treatment (BMT) | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | Utility Score | 0.01 units on a scale | Standard Deviation 0.16 |
| Best Medical Treatment (BMT) | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | VAS | 4.40 units on a scale | Standard Deviation 21.75 |
Comparison: Utility Scorep-value: 0.0197Wilcoxon (Mann-Whitney)
Comparison: VASp-value: 0.3807t-test, 2 sided
Secondary
Change in Functional Independence Measure (FIM) Score From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITB Therapy | Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | 2.68 units on a scale | Standard Deviation 10.31 |
| Best Medical Treatment (BMT) | Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | -2.58 units on a scale | Standard Deviation 11 |
p-value: 0.054Wilcoxon (Mann-Whitney)
Secondary
Change in Numeric Pain Rating Scale (NPRS) From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ITB Therapy | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Actual pain | -1.17 units on a scale | Standard Deviation 3.17 |
| ITB Therapy | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Least Pain | -1.61 units on a scale | Standard Deviation 2.29 |
| ITB Therapy | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Worst Pain | -1.35 units on a scale | Standard Deviation 2.42 |
| Best Medical Treatment (BMT) | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Actual pain | 0.00 units on a scale | Standard Deviation 3.29 |
| Best Medical Treatment (BMT) | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Least Pain | 0.24 units on a scale | Standard Deviation 3.07 |
| Best Medical Treatment (BMT) | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | Worst Pain | -0.04 units on a scale | Standard Deviation 3.69 |
Comparison: Actual Painp-value: 0.038Wilcoxon (Mann-Whitney)
Comparison: Least Painp-value: 0.0136Wilcoxon (Mann-Whitney)
Comparison: Worst Painp-value: 0.2427Wilcoxon (Mann-Whitney)
Secondary
Change in SF-12 (12-item Short Form) From Baseline to 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.
Time frame: Baseline and month 6
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ITB Therapy | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | PCS | 3.13 units on a scale | Standard Deviation 3.47 |
| ITB Therapy | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | MCS | 1.05 units on a scale | Standard Deviation 10.92 |
| Best Medical Treatment (BMT) | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | MCS | -0.82 units on a scale | Standard Deviation 7.81 |
| Best Medical Treatment (BMT) | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | PCS | -1.13 units on a scale | Standard Deviation 6.63 |
Comparison: PCSp-value: 0.1068t-test, 2 sided
Comparison: MCSp-value: 0.6824t-test, 2 sided
Secondary
Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to 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.
Time frame: Baseline and month 6
Population: Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ITB Therapy | Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | 0.26 units on a scale | Standard Deviation 0.58 |
| Best Medical Treatment (BMT) | Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | 0.05 units on a scale | Standard Deviation 0.58 |
p-value: 0.2105t-test, 2 sided
Secondary
Healthcare Resource Utilization
Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6
Time frame: baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6
Population: Intent to treat analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITB Therapy | Healthcare Resource Utilization | Second Assessment: nurse (home care) | NA Participants |
| ITB Therapy | Healthcare Resource Utilization | ITB test:general practitioner | 1 Participants |
| ITB Therapy | Healthcare Resource Utilization | Second Assessment: other | NA Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : nurse (hospital setting) | 1 Participants |
| ITB Therapy | Healthcare Resource Utilization | week 6: general practitioner | 4 Participants |
| ITB Therapy | Healthcare Resource Utilization | ITB test: neurologist | 1 Participants |
| ITB Therapy | Healthcare Resource Utilization | week 6: nurse (hospital setting) | 2 Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : orthopedic surgeon | 3 Participants |
| ITB Therapy | Healthcare Resource Utilization | week 6: other | 2 Participants |
| ITB Therapy | Healthcare Resource Utilization | ITB test :other | 3 Participants |
| ITB Therapy | Healthcare Resource Utilization | month 3: general practitioner | 7 Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : neurologist | 4 Participants |
| ITB Therapy | Healthcare Resource Utilization | month 3: neurologist | 1 Participants |
| ITB Therapy | Healthcare Resource Utilization | Second Assessment: general practitioner | NA Participants |
| ITB Therapy | Healthcare Resource Utilization | month 3: other | 6 Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : other | 10 Participants |
| ITB Therapy | Healthcare Resource Utilization | month 6: general practitioner | 8 Participants |
| ITB Therapy | Healthcare Resource Utilization | Second Assessment: neurologist | NA Participants |
| ITB Therapy | Healthcare Resource Utilization | month 6: neurologist | 3 Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : nurse (home care) | 0 Participants |
| ITB Therapy | Healthcare Resource Utilization | month 6: other | 8 Participants |
| ITB Therapy | Healthcare Resource Utilization | Baseline : general practitioner | 14 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 6: other | 11 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : general practitioner | 8 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : neurologist | 8 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : nurse (hospital setting) | 0 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : nurse (home care) | 1 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : orthopedic surgeon | 0 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Baseline : other | 13 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | ITB test:general practitioner | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | ITB test: neurologist | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | ITB test :other | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Second Assessment: general practitioner | 5 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Second Assessment: neurologist | 1 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Second Assessment: nurse (home care) | 1 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | Second Assessment: other | 4 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | week 6: general practitioner | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | week 6: nurse (hospital setting) | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | week 6: other | NA Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 3: general practitioner | 8 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 3: neurologist | 3 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 3: other | 9 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 6: general practitioner | 7 Participants |
| Best Medical Treatment (BMT) | Healthcare Resource Utilization | month 6: neurologist | 2 Participants |
Secondary
Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS)
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.
Time frame: month 6
Population: Intent to treat analysis
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ITB Therapy | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | goal achieved | 10 Participants |
| ITB Therapy | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | goal not achieved | 14 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | goal achieved | 8 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | goal not achieved | 16 Participants |
p-value: 0.7661Fisher Exact
Secondary
Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance
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.
Time frame: baseline, month 3, month 6
Population: Intent to treat analysis
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Baseline | HLP | 22 Participants |
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Baseline | LLP | 9 Participants |
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 3 | HLP | 19 Participants |
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 3 | LLP | 6 Participants |
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 6 | HLP | 19 Participants |
| ITB Therapy | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 6 | LLP | 5 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 6 | HLP | 19 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Baseline | HLP | 24 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 3 | LLP | 5 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Baseline | LLP | 5 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 6 | LLP | 5 Participants |
| Best Medical Treatment (BMT) | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Month 3 | HLP | 21 Participants |
p-value: 0.3676Cochran-Mantel-Haenszel
Secondary
Therapy Satisfaction
Patients were presented with two statements (I am satisfied with the reduction in spasticity provided by my treatment, and I would recommend this therapy to a friend). They agreed, disagreed or were neutral with the statements.
Time frame: month 6
Population: Intent to treat analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| ITB Therapy | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | disagree | 2 Participants |
| ITB Therapy | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | neutral | 4 Participants |
| ITB Therapy | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | agree | 16 Participants |
| ITB Therapy | Therapy Satisfaction | Patient Therapy Reccomandation | disagree | 3 Participants |
| ITB Therapy | Therapy Satisfaction | Patient Therapy Reccomandation | neutral | 3 Participants |
| ITB Therapy | Therapy Satisfaction | Patient Therapy Reccomandation | agree | 16 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Therapy Reccomandation | neutral | 4 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | disagree | 7 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Therapy Reccomandation | disagree | 5 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | neutral | 5 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Therapy Reccomandation | agree | 14 Participants |
| Best Medical Treatment (BMT) | Therapy Satisfaction | Patient Satisfaction with Spasticity Reduction | agree | 11 Participants |