Manual Therapy Before Neuromotor Rehab in Children with Cerebral Palsy
Official title: Short-Term Effects of Lower Limb Manual Therapy as a Preparatory Phase for Neuromotor Functional Therapy in Children With Spastic Cerebral Palsy: A Prospective Self-Controlled Pilot Study
Run by LIFE - Research and Care Institute - Santa Lucia IRCCS · NCT07902466 · Data updated 2026-11-12
In this pilot study, researchers test whether 30 minutes of lower-limb manual therapy before functional neuromotor therapy helps improve gait and motor performance in children with spastic cerebral palsy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Months to 10 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | LIFE - Research and Care Institute - Santa Lucia IRCCS Academic / other |
| Locations | 1 site (Roma, Roma) |
| Status | Recruiting |
| Started | October 15, 2026 |
| Main results expected | December 2026 |
| Study ends | March 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07902466 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children ages 1–10 with spastic CP (hemiplegia or diplegia), GMFCS I–IV, and MAS ≤ 3 in the lower limbs.
✕Probably not a fit
Children with more severe spasticity, recent lower-limb procedures, or cognitive barriers preventing task participation may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This monocentric pilot study enrolls 20 children with spastic CP (hemiplegic or diplegic) aged 1–10 years to see if a preparatory 30-minute lower-limb manual therapy session can immediately enhance gait and neuromuscular function when followed by functional rehabilitation. Each participant is studied under four conditions in a self-controlled design: baseline, post-manual therapy, post-functional therapy, and post-combined manual plus functional therapy, with a 7-day washout between sessions. Outcomes include gait analysis, range of motion, MAS, and gross motor function measures. The aim is to determine whether manual therapy primes the neuromotor system for subsequent rehabilitation to produce better short-term gait outcomes.
Why it matters
Potential benefit: If successful, patients could experience improved gait quality and motor control when manual therapy is used as a prep step before rehabilitation.
How similar studies have gone: Preliminary work in pediatric rehabilitation suggests that preparatory manual therapies can influence immediate gait parameters, but results are variable and require confirmation in CP.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of spastic Cerebral Palsy with lower limb involvement (hemiplegia or diplegia). * Age between 12 months and 10 years. * Gross Motor Function Classification System (GMFCS) level I, II, III, or IV. * Modified Ashworth Scale (MAS) score ≤ 3 in the lower limbs. Exclusion Criteria: * Botulinum toxin injection in the lower limbs within the past 6 months. * Prior functional orthopedic or neurosurgical procedures on the lower limbs. * Concurrent participation in other experimental clinical studies involving the lower limbs. * Cognitive impairment preventing comprehension of required motor tasks.
Where it's running
-
LIFE - Istituto Ricerca e Cura e Santa Lucia IRCCS
Roma, Roma, Italy Recruiting
Study contacts
- Study coordinator: Chiara Fantini, PT
- Email: c.fantini@hsantalucia.it
- Phone: +39 0651501490
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.