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| Name | Class |
|---|---|
| Shriners Hospitals for Children | OTHER |
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Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Selective dorsal rhizotomy (SDR) is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent further morbidities. Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The results of this study will have direct clinical impact by equipping providers with the necessary information to counsel families during medical decision making.
Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Excessive spasticity is thought to be uncomfortable, reduce function, cause gait deviations (e.g. equinus), and contribute toward musculoskeletal deformity and an elevated energy cost while walking. As such, SDR is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent the aforementioned morbidities.
Treatment philosophies differ widely in regards to how aggressively to manage spasticity. Some centers (e.g. Gillette) aggressively treat spasticity early in life through a variety of measures such as SDR, intrathecal baclofen pumps, and botulinum toxin injections. Other centers (e.g. Shriners Hospitals for Children - Salt Lake City and Spokane) offer little in the way of spasticity reduction treatments.
There are several compelling reasons to conduct the proposed research study. First, emerging evidence suggests that the elimination of spasticity during childhood via SDR does not prevent contractures and only partially explains poor gross motor function, both previously thought to be clear outcomes of the surgery. Additionally, many of the longitudinal cohort studies that examined SDR outcomes have shown many outcome measures peak 1-3 years after surgery, and then decline toward baseline (i.e. pre-SDR) levels. Lastly, the quality of the SDR outcome literature is poor. Rarely are outcomes looked at in context of a proper control group. Either a control group is absent or comprised of typically developing children. This limits our ability to understand how patients with cerebral palsy may age without undergoing an SDR.
Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The surgery, in general, is costly to families (time, expense, risk, etc.) and clinicians should have every confidence in the intended outcomes for any intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases (+SDR) | Patients with cerebral palsy that underwent an SDR |
| |
| Controls (-SDR) | Matched patients with cerebral palsy but did not undergo an SDR |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gait and Motion Analysis | Diagnostic Test | Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.) |
| Measure | Description | Time Frame |
|---|---|---|
| Three-dimensional gait and motion analysis | Compare three-dimensional gait kinematics and kinetics across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Energy expenditure | Compare energy expenditure across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Spasticity | Compare spasticity, measured by Modified Ashworth Score (0 no increase in tone - 4 rigid in flexion or extension), across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Passive range of motion | Compare passive range of motion, measured by lower extremity physical exam, across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Selective motor control | Compare selective motor control (0 patterned movement - 2 complete isolated movement) across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Lower extremity strength | Compare lower extremity strength, measured by the manual muscle test, across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Gross Motor Function Measure (GMFM-66) | Assess function using portions of the GMFM-66 (0 low function - 100 high function) and compare across groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change in gait and motion analysis | Compare change in gait kinematics and kinetics within groups and if the change is similar between groups | Baseline (qualifying exam for cases and controls) compared to long-term follow-up research visit (on average 10 years post-baseline) |
| Incidence of prior surgery and anti-spastic treatments |
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Inclusion Criteria for Controls (-SDR) and Cases (+SDR):
Controls (-SDR):
Cases (+SDR):
Exclusion Criteria:
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Former/current patients at Gillette Children's Specialty Healthcare, Shriners Hospitals for Children - Salt Lake City, or Shriners Hospitals for Children - Spokane
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| Name | Affiliation | Role |
|---|---|---|
| Michael Schwartz, PhD | Gillette Children's Specialty Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gillette Children's Specialty Healthcare | Saint Paul | Minnesota | 55101 | United States | ||
| Shriners Hospitals for Children - Salt Lake City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31227534 | Derived | Munger ME, Chen BP, MacWilliams BA, McMulkin ML, Schwartz MH. Comparing the effects of two spasticity management strategies on the long-term outcomes of individuals with bilateral spastic cerebral palsy: a multicentre cohort study protocol. BMJ Open. 2019 Jun 20;9(6):e027486. doi: 10.1136/bmjopen-2018-027486. |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005684 | Gait |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D016138 | Walking |
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| Gross Motor Function Measure (GMFM) | Diagnostic Test | Gross Motor Function Measure (GMFM) is an assessment used to evaluate gross motor function over time in individuals with cerebral palsy. The assessment is comprised of movement activities like standing, walking, running, and jumping |
|
| Surveys | Behavioral | Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history |
|
| Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Gillette Functional Assessment Questionnaire (Gillette FAQ) | Assess function and activity using the Gillette FAQ (self-reported survey, 0 low function - 10 high function) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Functional Mobility Scale (FMS) | Assess function and activity using the FMS (self-reported survey, 1 uses wheelchair - 6 independent) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Participation Enfranchisement survey | Assess participation using the Participation Enfranchisement survey (self-reported survey, true/false) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Diener Satisfaction with Life Scale | Assess satisfaction using the Diener Satisfaction with Life Scale (self-reported survey, 5 dissatisfied- 35 satisfied) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| World Health Organization (WHO) Quality of Life Scale | Assess satisfaction using the WHO Quality of Life Scale (self-reported survey, 0 low quality of life - 100 high quality of life) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Multiple Sclerosis Spasticity Scale (MSSS-88) | Assess pain using portions of the MSSS-88 (self-reported survey, 21 not at all bothered - 84 extremely bothered) and compare across groups | Time of long-term follow-up research visit (on average 10 years post-baseline) |
Incidence of prior surgery and anti-spastic treatments |
| Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Cost of prior surgery and anti-spastic treatments | Cost of prior surgery and anti-spastic treatments | Time of long-term follow-up research visit (on average 10 years post-baseline) |
| Salt Lake City |
| Utah |
| 84103 |
| United States |
| Shriners Hospitals for Childrens - Spokane | Spokane | Washington | 99204 | United States |
| D008124 |
| Locomotion |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |