Cerebral Palsy (CP)NCT07902466
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
A study testing Manual Therapy (T1 & T3) in people with Cerebral Palsy (CP) and Unilateral Spastic Cerebral Palsy, run by LIFE - Research and Care Institute - Santa Lucia IRCCS at 1 site in Italy.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 12 months to 10 years
- Conditions the study is for
- Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy, Bilateral Spastic Cerebral Palsy
- What is being tested?
- Manual Therapy (T1 & T3)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 15 Oct 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandra Medici, TNPEE contact
Italy1 site, 1 recruiting
- Recruiting
LIFE - Istituto Ricerca e Cura e Santa Lucia IRCCS
Roma, Roma, 00179
Chiara Fantini, PT, +39 0651501490, c.fantini@hsantalucia.it
Chiara Fantini, PT
About this study
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
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.
Read the detailed description
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).
- Conditions
- Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy, Bilateral Spastic Cerebral Palsy, Diplegic Cerebral Palsy With Spasticity, Hemiplegic Cerebral Palsy
- Being tested
- Manual Therapy (T1 & T3)
- Keywords
- Manual Therapy, Pediatric Rehabilitation, Gait Analysis
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Therapy (T1 & T3)Other
Bilateral lower limb treatment including myofascial release on triceps surae, hamstrings, adductors, and iliopsoas; passive joint mobilizations; and selective muscle stretching.
| Study group | Role | What they receive |
|---|---|---|
| All Participants (Self-Controlled Experimental Conditions) | Experimental | Participants complete four distinct evaluation/intervention conditions (T0, T1, T2, T3) separated by a 7-day wash-out period. Receives: Other: Manual Therapy (T1 & T3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Walking Speed via Instrumental Gait Analysis
Evaluation of walking speed measured in meters per second (m/s) using 3D motion analysis systems.
Measured: 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.
Secondary outcomes (5)
Change in Step Length via Instrumental Gait Analysis
Evaluation of step length measured in meters (m) using 3D motion analysis systems
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective self-controlled design where each participant undergoes all four experimental conditions (T0: Baseline, T1: Post-manual therapy, T2: Post-functional therapy, T3: Post-combined therapy) separated by a 7-day wash-out period.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LIFE - Research and Care Institute - Santa Lucia IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902466
- Sponsor's protocol ID
- 515/SL/26
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.
PubMed 23139425Shi X, Han J, Witchalls J, Waddington G, Adams R. Does treatment duration of manual therapy influence functional outcomes for individuals with chronic ankle instability: A systematic review with meta-analysis? Musculoskelet Sci Pract. 2019 Apr;40:87-95. doi: 10.1016/j.msksp.2019.01.015. Epub 2019 Feb 7.
PubMed 30753998Keter DL, Bialosky JE, Brochetti K, Courtney CA, Funabashi M, Karas S, Learman K, Cook CE. The mechanisms of manual therapy: A living review of systematic, narrative, and scoping reviews. PLoS One. 2025 Mar 18;20(3):e0319586. doi: 10.1371/journal.pone.0319586. eCollection 2025.
PubMed 40100908Kachmar O, Kushnir A, Matiushenko O, Hasiuk M. Influence of Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Participants With Cerebral Palsy: Randomized Controlled Trial. J Chiropr Med. 2018 Sep;17(3):141-150. doi: 10.1016/j.jcm.2018.03.004. Epub 2018 Aug 28.
PubMed 30228805Yanuck SB, Fox SK, Harting BR, Motyka TM. Effect of manual manipulation on mechanical gait parameters. J Osteopath Med. 2024 May 30;124(10):437-446. doi: 10.1515/jom-2023-0203. eCollection 2024 Oct 1.
PubMed 38807459Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.
PubMed 22925609Albright AL. Spasticity and movement disorders in cerebral palsy. Childs Nerv Syst. 2023 Oct;39(10):2877-2886. doi: 10.1007/s00381-023-06045-5. Epub 2023 Jul 6.
PubMed 37410128BAX MC. TERMINOLOGY AND CLASSIFICATION OF CEREBRAL PALSY. Dev Med Child Neurol. 1964 Jun;6:295-7. doi: 10.1111/j.1469-8749.1964.tb10791.x. No abstract available.
PubMed 14155190Youn PS, Cho KH, Park SJ. Changes in Ankle Range of Motion, Gait Function and Standing Balance in Children with Bilateral Spastic Cerebral Palsy after Ankle Mobilization by Manual Therapy. Children (Basel). 2020 Sep 18;7(9):142. doi: 10.3390/children7090142.
PubMed 32961844Hansen AB, Price KS, Loi EC, Buysse CA, Jaramillo TM, Pico EL, Feldman HM. Gait changes following myofascial structural integration (Rolfing) observed in 2 children with cerebral palsy. J Evid Based Complementary Altern Med. 2014 Oct;19(4):297-300. doi: 10.1177/2156587214540466. Epub 2014 Jul 2.
PubMed 24989994Faccioli S, Pagliano E, Ferrari A, Maghini C, Siani MF, Sgherri G, Cappetta G, Borelli G, Farella GM, Foscan M, Vigano M, Sghedoni S, Perazza S, Sassi S. Evidence-based management and motor rehabilitation of cerebral palsy children and adolescents: a systematic review. Front Neurol. 2023 May 25;14:1171224. doi: 10.3389/fneur.2023.1171224. eCollection 2023.
PubMed 37305763Chakraborty S, Nandy A, Kesar TM. Gait deficits and dynamic stability in children and adolescents with cerebral palsy: A systematic review and meta-analysis. Clin Biomech (Bristol). 2020 Jan;71:11-23. doi: 10.1016/j.clinbiomech.2019.09.005. Epub 2019 Oct 18.
PubMed 31677546Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
PubMed 28698802
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07902466
- Acronym / sponsor ID
- 515/SL/26
- Conditions
- Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy, Bilateral Spastic Cerebral Palsy, Diplegic Cerebral Palsy With Spasticity, Hemiplegic Cerebral Palsy
- Keywords
- Manual Therapy, Pediatric Rehabilitation, Gait Analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- LIFE - Research and Care Institute - Santa Lucia IRCCSUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective self-controlled design where each participant undergoes all four experimental conditions (T0: Baseline, T1: Post-manual therapy, T2: Post-functional therapy, T3: Post-combined therapy) separated by a 7-day wash-out period.
| Arm | Type | Receives |
|---|---|---|
| All Participants (Self-Controlled Experimental Conditions) | Experimental | Other: Manual Therapy (T1 & T3)Participants complete four distinct evaluation/intervention conditions (T0, T1, T2, T3) separated by a 7-day wash-out period. |
Who may qualify
- Ages
- 12 months to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | All Participants (Self-Controlled Experimental Conditions) |
Primary outcome
Change in Walking Speed via Instrumental Gait Analysis
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.
Evaluation of walking speed measured in meters per second (m/s) using 3D motion analysis systems.
5 secondary outcomes
Change in Step Length via Instrumental Gait Analysis
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Background: PubMed 23139425Ko J, Kim M. Reliability and responsiveness of the gross motor function measure-88 in children with cerebral palsy. Phys Ther. 2013 Mar;93(3):393-400. doi: 10.2522/ptj.20110374. Epub 2012 Nov 8.
- Background: PubMed 30753998Shi X, Han J, Witchalls J, Waddington G, Adams R. Does treatment duration of manual therapy influence functional outcomes for individuals with chronic ankle instability: A systematic review with meta-analysis? Musculoskelet Sci Pract. 2019 Apr;40:87-95. doi: 10.1016/j.msksp.2019.01.015. Epub 2019 Feb 7.
- Background: PubMed 40100908Keter DL, Bialosky JE, Brochetti K, Courtney CA, Funabashi M, Karas S, Learman K, Cook CE. The mechanisms of manual therapy: A living review of systematic, narrative, and scoping reviews. PLoS One. 2025 Mar 18;20(3):e0319586. doi: 10.1371/journal.pone.0319586. eCollection 2025.
- Background: PubMed 30228805Kachmar O, Kushnir A, Matiushenko O, Hasiuk M. Influence of Spinal Manipulation on Muscle Spasticity and Manual Dexterity in Participants With Cerebral Palsy: Randomized Controlled Trial. J Chiropr Med. 2018 Sep;17(3):141-150. doi: 10.1016/j.jcm.2018.03.004. Epub 2018 Aug 28.
- Background: PubMed 38807459Yanuck SB, Fox SK, Harting BR, Motyka TM. Effect of manual manipulation on mechanical gait parameters. J Osteopath Med. 2024 May 30;124(10):437-446. doi: 10.1515/jom-2023-0203. eCollection 2024 Oct 1.
- Background: PubMed 22925609Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.
- Background: PubMed 37410128Albright AL. Spasticity and movement disorders in cerebral palsy. Childs Nerv Syst. 2023 Oct;39(10):2877-2886. doi: 10.1007/s00381-023-06045-5. Epub 2023 Jul 6.
- Background: PubMed 14155190BAX MC. TERMINOLOGY AND CLASSIFICATION OF CEREBRAL PALSY. Dev Med Child Neurol. 1964 Jun;6:295-7. doi: 10.1111/j.1469-8749.1964.tb10791.x. No abstract available.
- Background: PubMed 32961844Youn PS, Cho KH, Park SJ. Changes in Ankle Range of Motion, Gait Function and Standing Balance in Children with Bilateral Spastic Cerebral Palsy after Ankle Mobilization by Manual Therapy. Children (Basel). 2020 Sep 18;7(9):142. doi: 10.3390/children7090142.
- Background: PubMed 24989994Hansen AB, Price KS, Loi EC, Buysse CA, Jaramillo TM, Pico EL, Feldman HM. Gait changes following myofascial structural integration (Rolfing) observed in 2 children with cerebral palsy. J Evid Based Complementary Altern Med. 2014 Oct;19(4):297-300. doi: 10.1177/2156587214540466. Epub 2014 Jul 2.
- Background: PubMed 37305763Faccioli S, Pagliano E, Ferrari A, Maghini C, Siani MF, Sgherri G, Cappetta G, Borelli G, Farella GM, Foscan M, Vigano M, Sghedoni S, Perazza S, Sassi S. Evidence-based management and motor rehabilitation of cerebral palsy children and adolescents: a systematic review. Front Neurol. 2023 May 25;14:1171224. doi: 10.3389/fneur.2023.1171224. eCollection 2023.
- Background: PubMed 31677546Chakraborty S, Nandy A, Kesar TM. Gait deficits and dynamic stability in children and adolescents with cerebral palsy: A systematic review and meta-analysis. Clin Biomech (Bristol). 2020 Jan;71:11-23. doi: 10.1016/j.clinbiomech.2019.09.005. Epub 2019 Oct 18.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy (CP)
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Comparison of Vestibular Stimulation and Core Stability Training on Sitting Balance in Hypotonic CP
Hypotonic Cerebral Palsy
Not yet recruiting
Video-based Visual Feedback Combined With Task-oriented Physiotherapy Among Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Active, not recruiting
Local Vibration for Drooling in Children With Cerebral Palsy
Cerebral Palsy (CP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alessandra Medici, TNPEE contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy (T1 & T3) in people with Cerebral Palsy (CP) and Unilateral Spastic Cerebral Palsy, run by LIFE - Research and Care Institute - Santa Lucia IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chiara Fantini, PT (+39 0651501490, c.fantini@hsantalucia.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Walking Speed via Instrumental Gait Analysis (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07902466, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.