An observational study in Cerebral Palsy, sponsored by Gillette Children's Specialty Healthcare. Completed at 3 sites in United States. Open to participants aged 21 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by Gillette Children's Specialty Healthcare · Observational
Among 372 studies in Cerebral Palsy with a site in United States — 76 open to participants now, 104 under way, none of them phase 3. Cerebral Palsy · United States.
Among the 372 studies in Cerebral Palsy with a site in United States, this one is the 32nd largest by enrollment of the 71 observational ones that give a count, is one of 17 that started in 2018, is one of 71 observational ones, and was the 183rd registered.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
Browse Cerebral Palsy studies →76 of the 372 studies in Cerebral Palsy with a site in United States are open now. Recruiting first, the newest first:
The Foundation for Orthopaedics and Regenerative Medicine · Sites in United States, Greece
University of Washington · Sites in United States
Ages 4–65
University of Wisconsin, Madison · Sites in United States
Ages 7–17
Columbia University · Sites in United States
Ages 18–80
Martin Piazza · Sites in United States
Ages 3–14
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 270 Cerebral Palsy studies recruiting now, 27 (10%) set no upper age limit and 235 (87%) stop at 75 or younger; 255 take children under 18; 51 take healthy volunteers.
This study: 21 Years to 45 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
372 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 36 · Phase 2 31 · Phase 3 18 · Phase 4 7
First in 1987; this study’s year is marked. 17 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 78 is above the median of 63 across 472 observational studies indexed under Cerebral Palsy.
Median enrollment 25 across the 296 interventional studies, 61 across the 71 observational. Of the 225 that completed or were terminated, 83 (37%) have results posted.
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34 of 372 have an industry lead sponsor. The 10 most frequent:
Gillette Children's Specialty Healthcare is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Gillette Children's Specialty Healthcare has 7 studies filed under Cerebral Palsy — fewer than ten, so there is no comparison to draw.
25 of the studies in Cerebral Palsy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07516067Martin PiazzaSpinal Cord Stimulation for Children With Cerebral Palsy | 2026-11 |
| NCT04630392Georgia State UniversityEffects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy | 2026-11-20 |
| NCT05339932Grand Valley State UniversityGrand Valley State University (GVSU) Skills on Wheels | 2026-11-30 |
| NCT06377085Shirley Ryan AbilityLabRepurposing 5-Azacytidine for the Treatment of Muscle Contractures in Children With Cerebral Palsy | 2026-12 |
| NCT04897347Teachers College, Columbia UniversityRobotic TruST-Postural Intervention for Children With Cerebral Palsy | 2026-12 |
Add all 25 to your calendar (.ics) → With an account.
Among the 372 studies in Cerebral Palsy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Former/current patients at Gillette Children's Specialty Healthcare, Shriners Hospitals for Children - Salt Lake City, or Shriners Hospitals for Children - Spokane
Inclusion Criteria for Controls (-SDR) and Cases (+SDR):
Controls (-SDR):
Cases (+SDR):
Exclusion Criteria:
Patients with cerebral palsy that underwent an SDR
Diagnostic Test: Gait and Motion Analysis · Diagnostic Test: Gross Motor Function Measure (GMFM) · Behavioral: Surveys
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
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) 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
Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history
Three-dimensional gait and motion analysis
Compare three-dimensional gait kinematics and kinetics across groups
Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
Energy expenditure
Compare energy expenditure across groups
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
Change in gait and motion analysis
Compare change in gait kinematics and kinetics within groups and if the change is similar between groups
Time frame: 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
Incidence 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
Cost of prior surgery and anti-spastic treatments
Time frame: Time of long-term follow-up research visit (on average 10 years post-baseline)
Plan to share: No
Ran from Nov 2018 to primary completion in Jan 2020, 14 months.
Of 214 non-industry observational studies under Cerebral Palsy, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 60. This study's 14 months is below that.
Counting every sponsor, half of 218 studies reached it within 21 months; a quarter within 8 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Gillette Children's Specialty Healthcare