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Completed

NCT Number: NCT03789786

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

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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Key information

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gillette Children's Specialty Healthcare, Saint Paul, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.)

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

Primary outcomes

  1. Three-dimensional gait and motion analysis

    Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)

    Compare three-dimensional gait kinematics and kinetics across groups

  2. Energy expenditure

    Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)

    Compare energy expenditure across groups

  3. Spasticity

    Time frame: 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

  4. Passive range of motion

    Time frame: 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

  5. Selective motor control

    Time frame: 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

  6. Lower extremity strength

    Time frame: 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

  7. Gross Motor Function Measure (GMFM-66)

    Time frame: 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

  8. Gillette Functional Assessment Questionnaire (Gillette FAQ)

    Time frame: 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

  9. Functional Mobility Scale (FMS)

    Time frame: 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

  10. Participation Enfranchisement survey

    Time frame: 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

  11. Diener Satisfaction with Life Scale

    Time frame: 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

  12. World Health Organization (WHO) Quality of Life Scale

    Time frame: 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

  13. Multiple Sclerosis Spasticity Scale (MSSS-88)

    Time frame: 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

Secondary outcomes

  1. Change in gait and motion analysis

    Time frame: 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

  2. Incidence of prior surgery and anti-spastic treatments

    Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)

    Incidence of prior surgery and anti-spastic treatments

  3. Cost 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

Sponsors and collaborators

Lead sponsor

Gillette Children's Specialty Healthcare

Other

Collaborators

  • Shriners Hospitals for Children

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2018
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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