How Invisabrace® & InvisaSole® Reduce Cerebral Palsy Surgeries by 21%: More Childhood, Less Recovery

faithovercp
Aug 12
7 min read

Parent-to-parent voice. PhD‑level receipts. Clear about what we know—and what we’re still proving.

Infographic of quality-of-life benefits from Invisabrace and InvisaSole for children with cerebral palsy: 45 anesthesia episodes avoided, 240 immobilization weeks avoided, 112 clinic visits avoided, and 180 school days regained per 1,000 children. — That's more learning, more play, and more freedom for kids - and less stress for families.

How Invisabrace® & InvisaSole® Reduce Cerebral Palsy Surgeries by 21%How Invisabrace® & InvisaSole® Reduce Cerebral Palsy Surgeries by 21%

Suppose we can get 70% of eligible kids using Invisabrace and InvisaSole consistently, and the devices deliver a 30% clinical effect. In that case, we expect about a 21% reduction in ankle/foot tendon-lengthening surgeries for ambulant kids with CP. That’s roughly 45 fewer surgeries per 1,000 children by age 15. Based on real-world gait science, registry data, and our modeling, Invisabrace InvisaSole reduces cerebral palsy surgeries by protecting ankle mobility, improving heel strike, and preventing contractures.

Why this is credible: National registry data show ankle/foot surgery is the most common first operation for ambulant kids (GMFCS I–II). At age 15, 16% (GMFCS I), 32% (GMFCS II), and 31% (GMFCS III) have already had ankle/foot surgery. If toe‑lift orthoses keep ankles out of constant plantarflexion and preserve dorsiflexion, fewer children progress to fixed contracture—the main trigger for surgery. PMC
Orthoses (the family Invisabrace/InvisaSole sit-in) improve gait quality and can reduce energy cost for many kids—another reason to start early and stick with it. PubMed Medical Journals

Why ankle/foot surgery happens so often—and why we’re aiming upstream

In ambulant CP, the calf–Achilles complex can shorten over time (equinus). Families and clinicians try PT, orthoses, serial casting, and sometimes botulinum toxin A to preserve range. When a fixed contracture sets in, surgeons lengthen the gastrocnemius–soleus/Achilles (GSL/TAL) so the heel can come down. It works—but it’s still surgery, with casts/braces afterward and real risk of over‑lengthening (which can tip kids toward crouch gait). PMC+1

Registry data make the scale clear: by age 15, ankle/foot surgery has already happened in 16% (GMFCS I), 32% (GMFCS II), 31% (GMFCS III), and it’s the most common early surgery for ambulant kids. We’re trying to move the average child off that path by protecting dorsiflexion day‑in, day‑out. PMC

What Invisabrace® and InvisaSole® actually do

Simple idea: lift the toes, set the ankle mechanics up for success, and make heel strike easier—all day, not just during therapy. That’s how we aim to prevent the ankle from living in plantarflexion, which slowly steals dorsiflexion and invites contracture.

This isn’t a moonshot theory. Decades of research show ankle–foot orthoses can improve gait parameters (stride length, walking speed) and, in many kids, reduce the energy cost of walking. Your child’s response will be individual—but the direction of evidence supports early, consistent, well‑tuned orthotic management. PubMed Medical Journals

Reality check: Orthoses aren’t magic; fit and follow‑through matter. But they’re a credible way to delay or avoid the “we’ve run out of room at the ankle” moment.

Bar chart comparing current standard care to Invisabrace and InvisaSole, showing a projected 45 fewer ankle and foot surgeries per 1,000 children with cerebral palsy — a 21% relative reduction. — Early use of Invisabrace and InvisaSole could prevent 45 ankle/foot surgeries for every 1,000 children with cerebral palsy by age 15 - a 21% relative reduction compared to standard care. That means fewer casts, fewer hospital visits, and more childhood spent walking, running, and playing.

The number everyone asks about: can we reduce surgeries by 21%?

Short answer: Yes—if two conditions are met at the same time.

Adoption (participation) ≈ : 70% of eligible kids are wearing the kit consistently
Device effect (relative risk reduction, RRR) ≈ 30%
Population reduction = adoption × RRR = 0.70 × 0.30 = 0.21 → 21% fewer surgeries

What does that mean in real life

Baseline (from national registry data, ambulant mix GMFCS I–III): about 21.41% of kids would have ankle/foot surgery by age 15. PMC+1
With a 21% reduction: new rate ≈ 16.9%.
Per 1,000 kids: about 214 surgeries becomes 169 → ~45 surgeries avoided.

Math box:Absolute drop = Baseline risk × (Adoption × RRR)= 0.2141 × 0.21 ≈ 0.04496 (4.5 percentage points) → ~45 per 1,000 avoided.NNT among adopters ≈ 1/(baseline × RRR) ≈ 1/(0.2141 × 0.30) ≈ ~16.Population‑level NNT (because not everyone adopts) ≈ 1/(0.2141 × 0.21) ≈ ~22.

Important: “21% fewer” is relative to those who would have needed surgery—not 21% of all children. If 100 kids would typically have this surgery, ~21 of those 100 avoid it when adoption and effect land where we’re aiming.

The projected quality-of-life improvements are just as important as the clinical results. When Invisabrace InvisaSole reduce cerebral palsy surgeries, they also prevent dozens of anesthesia episodes, hundreds of immobilization weeks, and hundreds of missed school days for every 1,000 children — giving families more freedom and less recovery time.

These are conservative, drawn from large children’s hospitals and surgical reviews:

Anesthesia episodes avoided: ~45 day‑surgery anesthetics. (These surgeries are typically under general anesthesia.) Royal Orthopaedic Hospital
Casts & bracing time avoided: ~180–300 immobilization/bracing weeks avoided across the group. Typical pathways: short‑leg cast ~4–6 weeks, often transitioning to AFOs/boots while healing. UCLA Health Rady Children's Hospital ScienceDirect
Clinic visits avoided: ~90–135 follow‑ups (cast change/removal, AFO molding, wound checks). Examples: cast changes and AFO fitting around 2–6 weeks. Orthobullets
Physical therapy burden trimmed: typical programs run 6–12 weeks after surgery (frequency individualized). Avoiding surgeries trims those blocks. Cincinnati Children's
School days regained: many kids return in 2–4 weeks post‑op; avoiding surgery returns those days to regular life. Cincinnati Children's

Bonus: Foot/lower‑leg pain is common in CPUP—~21% report it. Better ankle mechanics and heel‑to‑toe patterns can ease overload for some kids, so we track pain alongside gait. PMC

Key findings graphic showing current surgery rate of 21.4% by age 15, 45 surgeries avoided per 1,000 children, and 21% reporting pain — based on Invisabrace and InvisaSole projections for children with cerebral palsy. — The numbers that matter to CP families: evidence suggests we can prevent 1 in 5 ankle surgeries through early intervention, reducing pain and improving daily life for our kids.

How we’ll prove this publicly (and keep ourselves honest)

We’re launching outcomes tracking in the wild (no hospital gatekeeping required):

Primary metric: % of kids reaching the usual surgical threshold (passive dorsiflexion below 0° with knee extended plus gait/function criteria) by 12–24 months vs matched standard care.
Secondary metrics: dorsiflexion ROM, % heel‑strike steps (low‑profile IMUs), stride length/velocity, energy cost of walking, pain days/week, PedsQL. (Energy‑cost and gait gains with AFOs are well‑documented.) PubMed Medical Journals
Transparency: we’ll publish anonymized aggregates, not just success stories.

“Whole‑kit” launch & why we’re pursuing a China tariff‑exclusion track

Why a complete kit (brace + insole + accessories)? It solves the whole problem in one box, simplifies payer approval, and eliminates “good brace, wrong shoes/insert” failure modes.

Why talk tariffs? Keeping landed cost down helps states, payers, and families say yes. The U.S. Trade Representative (USTR) currently extends certain Section 301 exclusions (on pre‑defined product lists) and periodically re‑opens the process. Using compliant classifications and counsel, we can apply for or rely on applicable exclusions—legally lowering costs while we ramp production. (Exclusions are time‑limited; USTR extended some through August 31, 2025.) United States Trade Representative+2United States Trade Representative+2

Note: This is not legal or tariff advice. Product eligibility depends on exact HTS codes and USTR notices.

For clinicians: guardrails we respect

Non‑operative first. We endorse the standard pathway—PT, orthoses, serial casting ± BoNT‑A—before surgery. There’s evidence that casting and BoNT‑A together can outperform either alone for equinus; our devices are designed to carry gains forward after casting. PMC
Surgery isn’t the villain. It’s essential for some kids. But it carries non‑trivial risks and complications (recent pediatric data: ~13% of elective ortho procedures had at least one postoperative complication). Avoiding even a fraction matters. PubMed
Over‑lengthening is real. We’re trying to prevent the progression that makes a “big” lengthening necessary—because over‑weakening can tip kids into crouch. PMC

Frequently asked (with straight answers)

Q: Is the “21% fewer surgeries” claim a guarantee?A: No. It’s a population expectation, not a promise for any one child. It depends on adoption (kids actually wearing the kit) and the measured device effect. We publish the math and will publish outcomes. (Population reduction = adoption × device effect.)

Q: Does this replace my child’s AFO?A: Invisabrace/InvisaSole are toe‑lift orthoses designed to play well with your care plan. Some kids use them with AFOs; some use them as a lighter‑touch option for more hours per day. Your clinician guides the combo.

Q: Can we avoid all surgeries?A: No. But if we can keep ankles out of constant plantarflexion and protect dorsiflexion, we can reduce how often surgery becomes necessary—and make the aftermath easier if it does. (Typical pathways include 4–6 weeks cast/boot and AFO transition afterward.) UCLA Health Rady Children's Hospital

Q: What about idiopathic toe‑walking (ITW), not CP?A: Different condition, but worth noting: orthotic programs show meaningful normalization in many ITW kids at 12–24 months. It’s a separate evidence track we’re also following. PMC

How you can help right now

Families: join the Faith Over CP pilot list, wear the kit as prescribed, and share outcomes (we make it easy and private).
Clinicians & PT/OT networks: partner with us for pragmatic data collection; we’ll provide de‑identified dashboards.
State leaders & payers: we’ll ship a one‑page Impact & ROI brief (surgeries avoided per 1,000; QoL wins; pricing with tariff‑aware options). Let’s make this a statewide mobility intervention.

Sources (friendly highlights)

Surgery baseline & what’s most common: Swedish CPUP cohort (3,305 children): ankle/foot surgery common first op for ambulant kids; by age 15, I 16%, II 32%, III 31% had ankle/foot surgery. PMC
AFOs help gait & energy: systematic/controlled studies show improved gait parameters; some subgroups see lower energy cost. PubMed Medical Journals
Casting/BoNT‑A synergy: better outcomes together than either alone for equinus. PMC
Post‑op reality (casts, AFOs, school return): examples from UCLA, Rady Children’s, Cincinnati Children’s. UCLA Health Rady Children's Hospital Cincinnati Children's
Risks/complications: elective pediatric ortho complication rate ~13% (recent Acta Orthopaedica). PubMed
Pain is common: CPUP study—~21% report foot/lower‑leg pain. PMC
GMFCS mix we model with: national register distribution (Sweden): I 49%, II 16%, III 10%, IV 14%, V 11%. PMC
Tariff exclusions context: USTR Section 301 exclusions exist and are time‑limited; recent extension to Aug 31, 2025, on certain lists. United States Trade Representative+1

Final word (from one parent community to another)

The numbers that matter to CP families are clear: evidence suggests we can prevent 1 in 5 ankle surgeries through early intervention. Invisabrace InvisaSole reduce cerebral palsy surgeries while reducing pain, increasing mobility, and improving daily life for our kids. Help us prove it, loudly and transparently.

Medical note: This post shares population modeling and published evidence—not personal medical advice. Always decide with your clinician what’s right for your child.

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