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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789786
• Other study ID #: STUDY00002353
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: October 2023
• Source: Gillette Children's Specialty Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.)
• 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

Locations

Country	Name	City	State
United States	Gillette Children's Specialty Healthcare	Saint Paul	Minnesota
United States	Shriners Hospitals for Children - Salt Lake City	Salt Lake City	Utah
United States	Shriners Hospitals for Childrens - Spokane	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Gillette Children's Specialty Healthcare	Shriners Hospitals for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Energy expenditure	Compare energy expenditure across groups	Time of long-term follow-up research visit (on average 10 years post-baseline)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)