Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy Compared to a Matched Control Group

Conditions
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Cerebral Palsy

Intervention / Treatment
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* Diagnostic Test: Gait and Motion Analysis
* Diagnostic Test: Gross Motor Function Measure (GMFM)
* Behavioral: Surveys


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases (+SDR)<br>Patients with cerebral palsy that underwent an SDR | Diagnostic Test: Gait and Motion Analysis<br>* Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)<br>Diagnostic Test: Gross Motor Function Measure (GMFM)<br>* 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<br>Behavioral: Surveys<br>* Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history<br>|
| Controls (-SDR)<br>Matched patients with cerebral palsy but did not undergo an SDR | Diagnostic Test: Gait and Motion Analysis<br>* Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)<br>Diagnostic Test: Gross Motor Function Measure (GMFM)<br>* 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<br>Behavioral: Surveys<br>* Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Selective Dorsal Rhizotomy, Outcomes