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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-01

Study Completion Date

2020-01-31

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.

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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.

Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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Cases (+SDR)

Patients with cerebral palsy that underwent an SDR

Gait and Motion Analysis

Intervention Type 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.)

Gross Motor Function Measure (GMFM)

Intervention Type 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

Intervention Type BEHAVIORAL

Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history

Controls (-SDR)

Matched patients with cerebral palsy but did not undergo an SDR

Gait and Motion Analysis

Intervention Type 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.)

Gross Motor Function Measure (GMFM)

Intervention Type 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

Intervention Type BEHAVIORAL

Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history

Interventions

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Gait 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.)

Intervention Type DIAGNOSTIC_TEST

Gross 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

Intervention Type DIAGNOSTIC_TEST

Surveys

Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Michael H Schwartz, PhD

Director of Bioengineering Research, Gillette Children's Specialty Healthcare; Associate Professor of Orthopaedic Surgery, University of Minnesota - Twin Cities

Responsibility Role PRINCIPAL_INVESTIGATOR