Cerebral Palsy
Conditions
Keywords
Selective Dorsal Rhizotomy, Outcomes
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTGait and Motion Analysis
Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
DIAGNOSTIC_TESTGross Motor Function Measure (GMFM)
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
BEHAVIORALSurveys
Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history
Sponsors
Shriners Hospitals for Children
Gillette Children's Specialty Healthcare
Study design
Observational model
CASE_CONTROL
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
for Controls (-SDR) and Cases (+SDR): * Able to speak and read English * Diagnosed with bilateral cerebral palsy (i.e. no hemiplegics) * Minimum age of 21 years presently * Had a baseline gait and motion analysis Controls (-SDR): * No SDR * No history of intrathecal baclofen (ITB) pump implantation for \> 1 year * No ITB pump at time of long-term follow-up (explant \> or = 6 months) * No history of oral baclofen for \> 1 year * No oral baclofen use at time of long-term follow-up * No more than 10 sessions on botulinum toxin, phenol, or alcohol injection Cases (+SDR): * History of SDR \> 5 years ago * Had a baseline gait analysis \< or = 18 months before SDR
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Sclerosis Spasticity Scale (MSSS-88) | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess pain using portions of the MSSS-88 (self-reported survey, 21 not at all bothered - 84 extremely bothered) and compare across groups |
| Participation Enfranchisement survey | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess participation using the Participation Enfranchisement survey (self-reported survey, true/false) and compare across groups |
| Diener Satisfaction with Life Scale | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess satisfaction using the Diener Satisfaction with Life Scale (self-reported survey, 5 dissatisfied- 35 satisfied) and compare across groups |
| World Health Organization (WHO) Quality of Life Scale | Time of long-term follow-up research visit (on average 10 years post-baseline) | 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 |
| Three-dimensional gait and motion analysis | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare three-dimensional gait kinematics and kinetics across groups |
| Energy expenditure | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare energy expenditure across groups |
| Spasticity | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare spasticity, measured by Modified Ashworth Score (0 no increase in tone - 4 rigid in flexion or extension), across groups |
| Passive range of motion | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare passive range of motion, measured by lower extremity physical exam, across groups |
| Selective motor control | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare selective motor control (0 patterned movement - 2 complete isolated movement) across groups |
| Lower extremity strength | Time of long-term follow-up research visit (on average 10 years post-baseline) | Compare lower extremity strength, measured by the manual muscle test, across groups |
| Gross Motor Function Measure (GMFM-66) | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess function using portions of the GMFM-66 (0 low function - 100 high function) and compare across groups |
| Gillette Functional Assessment Questionnaire (Gillette FAQ) | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess function and activity using the Gillette FAQ (self-reported survey, 0 low function - 10 high function) and compare across groups |
| Functional Mobility Scale (FMS) | Time of long-term follow-up research visit (on average 10 years post-baseline) | Assess function and activity using the FMS (self-reported survey, 1 uses wheelchair - 6 independent) and compare across groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of prior surgery and anti-spastic treatments | Time of long-term follow-up research visit (on average 10 years post-baseline) | Incidence 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) | Cost of prior surgery and anti-spastic treatments |
| Change in gait and motion analysis | Baseline (qualifying exam for cases and controls) compared to long-term follow-up research visit (on average 10 years post-baseline) | Compare change in gait kinematics and kinetics within groups and if the change is similar between groups |
Countries
United States
Outcome results
None listed