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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789786
Recruitment Status : Enrolling by invitation
First Posted : December 31, 2018
Last Update Posted : December 31, 2018
Sponsor:
Collaborator:
Shriners Hospitals for Children
Information provided by (Responsible Party):
Michael H Schwartz, PhD, Gillette Children's Specialty Healthcare

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.

Condition or disease Intervention/treatment
Cerebral Palsy Diagnostic Test: Gait and Motion Analysis Diagnostic Test: Gross Motor Function Measure (GMFM) Behavioral: Surveys

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.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Other
Official Title: Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy Compared to a Matched Control Group
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cases (+SDR)
Patients with cerebral palsy that underwent an SDR
Diagnostic Test: 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.)

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

Behavioral: Surveys
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
Diagnostic Test: 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.)

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former/current patients at Gillette Children's Specialty Healthcare, Shriners Hospitals for Children - Salt Lake City, or Shriners Hospitals for Children - Spokane
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789786


Locations
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United States, Minnesota
Gillette Children's Specialty Healthcare
Saint Paul, Minnesota, United States, 55101
United States, Utah
Shriners Hospitals for Children - Salt Lake City
Salt Lake City, Utah, United States, 84103
United States, Washington
Shriners Hospitals for Childrens - Spokane
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Gillette Children's Specialty Healthcare
Shriners Hospitals for Children
Investigators
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Principal Investigator: Michael Schwartz, PhD Gillette Children's Specialty Healthcare

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael H Schwartz, PhD, Director of Bioengineering Research, Gillette Children's Specialty Healthcare; Associate Professor of Orthopaedic Surgery, University of Minnesota - Twin Cities, Gillette Children's Specialty Healthcare
ClinicalTrials.gov Identifier: NCT03789786    
Other Study ID Numbers: STUDY00002353
First Posted: December 31, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael H Schwartz, PhD, Gillette Children's Specialty Healthcare:
Selective Dorsal Rhizotomy
Outcomes
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases