An interventional study of Manual Therapy (T1 & T3) in Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy and Bilateral Spastic Cerebral Palsy, sponsored by LIFE - Research and Care Institute - Santa Lucia IRCCS. Recruiting at 1 site in Italy. Open to participants aged 12 Months to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by LIFE - Research and Care Institute - Santa Lucia IRCCS · Not applicable, Interventional, and Treatment
This pilot study aims to evaluate the immediate, short-term biomechanical and neuromuscular effects of lower limb manual therapy applied as a preparatory phase prior to functional neuromotor rehabilitation in children with spastic cerebral palsy (hemiplegic and diplegic forms). Using a prospective self-controlled design, 20 children will be assessed under four experimental conditions (baseline, post-manual therapy, post-functional therapy, and post-combined manual + functional therapy) to determine if manual techniques enhance gait parameters and motor execution.
Cerebral Palsy (CP) is the leading cause of permanent motor disability in childhood, frequently causing hypertonia, myofascial retractions, altered neuromuscular recruitment, and compromised gait function. Manual therapy techniques (myofascial release, joint mobilizations, passive stretching) have emerged as potential complementary interventions to reduce spasticity and improve joint mobility.
This monocentric prospective study investigates whether lower limb manual therapy immediately improves spatio-temporal parameters and quality of gait when used prior to functional neuromotor training. Twenty pediatric patients aged 12 months to 10 years with spastic CP (GMFCS I-IV) will be enrolled. Each participant serves as their own control. Assessments will occur at four time points with a 7-day wash-out period between sessions:
T0 (Baseline): Pre-treatment assessment (at least 48 hours after any previous rehabilitation session).
T1 (Post-Manual Therapy): Immediate evaluation following 30 minutes of targeted lower limb manual therapy.
T2 (Post-Functional Therapy): Immediate evaluation following 30 minutes of functional neuromotor therapy alone.
T3 (Post-Combined Therapy): Immediate evaluation following 30 minutes of manual therapy immediately followed by 30 minutes of functional neuromotor therapy.
Evaluations include instrumental Gait Analysis (spatiotemporal and kinematic/EMG parameters), Range of Motion (ROM) measurements, Modified Ashworth Scale (MAS), and Gross Motor Function Measure (GMFM-88, Dimensions D and E).
1,898 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 20 is below the median of 33 across 1,399 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →LIFE - Research and Care Institute - Santa Lucia IRCCS is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participants complete four distinct evaluation/intervention conditions (T0, T1, T2, T3) separated by a 7-day wash-out period.
Other: Manual Therapy (T1 & T3)
Bilateral lower limb treatment including myofascial release on triceps surae, hamstrings, adductors, and iliopsoas; passive joint mobilizations; and selective muscle stretching.
Change in Walking Speed via Instrumental Gait Analysis
Evaluation of walking speed measured in meters per second (m/s) using 3D motion analysis systems.
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks.
Change in Step Length via Instrumental Gait Analysis
Evaluation of step length measured in meters (m) using 3D motion analysis systems
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks.
Change in Cadence via Instrumental Gait Analysis
Evaluation of cadence measured in steps per minute (steps/min) using 3D motion analysis systems
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks
Change in Double Support Time via Instrumental Gait Analysis
Evaluation of double support time measured as a percentage of the gait cycle (% of gait cycle) using 3D motion analysis systems
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks
Change in Joint and Elevation Angles via Instrumental Gait Analysis
Evaluation of joint angles, elevation angles, and foot lift measured in degrees using 3D motion analysis systems
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks
Change in Electromyographic (EMG) Activity Parameters
Evaluation of center of activity of EMG signals, FWHM (full width at half maximum), coactivation index, and mean intensity of EMG signals using 3D motion analysis systems
Time frame: Measured at T0 (Baseline, before intervention period), T1 (Immediate post-Manual Therapy, week 1), T2 (Immediate post-Functional Therapy, week 2), and T3 (Immediate post-Combined Therapy, week 3), over a total study duration of 4 weeks
Plan to share: No
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
Of 888 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 2 months is below that.
Counting every sponsor, half of 906 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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LIFE - Research and Care Institute - Santa Lucia IRCCS