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.
Study Type
OBSERVATIONAL
Enrollment
78
Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
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
Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States
Shriners Hospitals for Children - Salt Lake City
Salt Lake City, Utah, United States
Shriners Hospitals for Childrens - Spokane
Spokane, Washington, United States
Three-dimensional gait and motion analysis
Compare three-dimensional gait kinematics and kinetics across groups
Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
Energy expenditure
Compare energy expenditure across groups
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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
Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
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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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
Change in gait and motion analysis
Compare change in gait kinematics and kinetics within groups and if the change is similar between groups
Time frame: 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
Incidence of prior surgery and anti-spastic treatments
Time frame: 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 frame: Time of long-term follow-up research visit (on average 10 years post-baseline)