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

NCT03789786 | Completed

• 1 other identifier: STUDY00002353
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 3

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.

Conditions

Cerebral Palsy

Keywords

Selective Dorsal Rhizotomy; Outcomes

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (3)

• 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)

• 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

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

Study Arms (2)

Cases (+SDR)

Patients with cerebral palsy that underwent an SDR

Diagnostic Test: Gait and Motion Analysis; Diagnostic Test: Gross Motor Function Measure (GMFM); Behavioral: Surveys

Controls (-SDR)

Matched patients with cerebral palsy but did not undergo an SDR

Diagnostic Test: Gait and Motion Analysis; Diagnostic Test: Gross Motor Function Measure (GMFM); Behavioral: Surveys

Interventions

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.)

Cases (+SDR); Controls (-SDR)

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

Cases (+SDR); Controls (-SDR)

Surveys BEHAVIORAL

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

Cases (+SDR); Controls (-SDR)

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• none

Sponsors & Collaborators

• Gillette Children's Specialty Healthcare: lead
• Shriners Hospitals for Children: collaborator

Study Sites (3)

Gillette Children's Specialty Healthcare

Saint Paul, Minnesota, 55101, United States

Location

Shriners Hospitals for Children - Salt Lake City

Salt Lake City, Utah, 84103, United States

Location

Shriners Hospitals for Childrens - Spokane

Spokane, Washington, 99204, United States

Location

Related Publications (1)

• Munger ME, Chen BP, MacWilliams BA, McMulkin ML, Schwartz MH. Comparing the effects of two spasticity management strategies on the long-term outcomes of individuals with bilateral spastic cerebral palsy: a multicentre cohort study protocol. BMJ Open. 2019 Jun 20;9(6):e027486. doi: 10.1136/bmjopen-2018-027486.

  PMID: 31227534 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Gait; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Michael Schwartz, PhD

  Gillette Children's Specialty Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Bioengineering Research, Gillette Children's Specialty Healthcare; Associate Professor of Orthopaedic Surgery, University of Minnesota - Twin Cities

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: December 31, 2018
• Study Start: November 1, 2018
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: October 13, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)