NCT06837025

Brief Summary

The purpose of the study is to investigate the potential additional benefits of a relatively new physiotherapy method, fascial manipulation, in the rehabilitation of movement difficulties or other problems caused by CP (cerebral palsy). A physiotherapist specialized in fascial manipulation specifically treats the muscle fascia, which plays a central role in the problems associated with CP. Fascial manipulation feels just like a massage but does not hurt. The purpose of the study is to determine how physiotherapeutic rehabilitation methods should be further developed in Finland and elsewhere. Fascial manipulation was originally developed in Italy and is used to treat many musculoskeletal problems. There have been few studies on the effectiveness of fascial manipulation in the context of CP problems. It is important to obtain more research evidence, which is why conducting this study is crucial.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Oct 2024Dec 2027

Study Start

First participant enrolled

October 4, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

January 31, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

Cerebral PalsyFascial manipulationFlexibilitySpasticityWalking abilityInterview studyqualitative study

Outcome Measures

Primary Outcomes (1)

  • Six-minute walking test

    Distance covered six minutes

    From enrollment to the end of treatment at 8 weeks

Secondary Outcomes (4)

  • Walking efficiency

    From enrollment to the end of treatment at 8 weeks

  • Ankle joint hyper-resistance

    From enrollment to the end of treatment at 8 weeks

  • Gait pattern

    From enrollment to the end of treatment at 8 weeks

  • Interview: Parents of a child with cerebral palsy and their physiotherapist

    From enrollment to the end of treatment at 8 weeks

Study Arms (2)

Fascial manipulation

ACTIVE COMPARATOR

In fascia manipulation (FM), the treatment targets the deep fascia related to muscles, including the aponeurotic and epimysial fascia. Treatment points are selected based on a thorough assessment, including the client's history, movement tests and analysis, and palpation tests. Fascia manipulation treatment affects the hyaluronan and viscosity of the muscle fascia. In the treatment of spasticity, the treatment points are in the body parts involved in spastic movement patterns. In this study, fascia manipulation is performed once a week, and the therapist provides instructions for self-exercises to the child with CP. The child's own physiotherapy continues at the same time.

Other: Fascial manipulation

Stretching

ACTIVE COMPARATOR

The stretches are based on the article published 2024 at University of Jyväskylä. Four sets of 45-second manual passive-static guided stretches to the pain threshold are performed for the ankle extensors, hip flexors, hip adductors, and knee flexors.

Other: Fascial manipulation

Interventions

Fascial manipulation once a week

Also known as: 1
Fascial manipulationStretching

Eligibility Criteria

Age7 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 7-14 years
  • GMFCS level 2-3
  • Good cooperation
  • Family living in the Helsinki metropolitan area

You may not qualify if:

  • The child has previously received fascia manipulation by a Stecco-trained therapist or other fascia treatment (if done within the last 6 months)
  • Surgeries on the lower limbs (if done within the last 12 months)
  • Electrical stimulation treatments (if done within the last 3 months)
  • Botox treatments on the lower limbs (if done within the last 6 months)
  • Reduced cognitive level
  • Severe visual impairment (unable to perform the walking test)
  • Other illnesses: psychological or other serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Hospital

Helsinki, 00290, Finland

RECRUITING

Related Publications (19)

  • Tolvanen 2019 http://www.fascialmanipulation.com/wp-content/uploads/ATTI-2019-PDF.pdf

    RESULT
  • Tolvanen 2018, Treatment of neurological pediatric patients in Julia Ann Day, Fascial Manipulation-Stecco -method The practitioner´s perspective, Handspring .

    RESULT
  • Tolvanen, Lahtinen-Suopanki, 2022, Fascia Research Congress (poster), The Experiences and Benefits of Applying Fascial Manipulation® Stecco Method in Neurological Physiotherapy for Children and Adults. https://www.fasciaresearchsociety.org/docs/2022_FRC_AbstractBook.pdf

    RESULT
  • BOBATH K, BOBATH B. THE FACILITATION OF NORMAL POSTURAL REACTIONS AND MOVEMENTS IN THE TREATMENT OF CEREBRAL PALSY. Physiotherapy. 1964 Aug;50:246-62. No abstract available.

  • Stecco L, Basmanjian JV, Day JA. (2004). Fascial manipulation for musculoskeletal pain (pp. 123-130). Padova: Piccin.

    RESULT
  • Stecco A, Raghavan P: Peripheral Mechanisms Contributing to Spasticity and Implications for Treatment. Curr Phys Med Rehabil Rep. 2014;2:121-127. DOI 10.1007/s40141-014-0052-3.

    RESULT
  • Hansen 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.

  • Pintucci M, Simis M, Imamura M, Pratelli E, Stecco A, Ozcakar L, Battistella LR. Successful treatment of rotator cuff tear using Fascial Manipulation(R) in a stroke patient. J Bodyw Mov Ther. 2017 Jul;21(3):653-657. doi: 10.1016/j.jbmt.2016.12.007. Epub 2016 Dec 22.

  • Faccioli 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.

  • Amir A, Kim S, Stecco A, Jankowski MP, Raghavan P. Hyaluronan homeostasis and its role in pain and muscle stiffness. PM R. 2022 Dec;14(12):1490-1496. doi: 10.1002/pmrj.12771. Epub 2022 Feb 25.

  • Cowman MK, Schmidt TA, Raghavan P, Stecco A. Viscoelastic Properties of Hyaluronan in Physiological Conditions. F1000Res. 2015 Aug 25;4:622. doi: 10.12688/f1000research.6885.1. eCollection 2015.

  • Smith LR, Lee KS, Ward SR, Chambers HG, Lieber RL. Hamstring contractures in children with spastic cerebral palsy result from a stiffer extracellular matrix and increased in vivo sarcomere length. J Physiol. 2011 May 15;589(Pt 10):2625-39. doi: 10.1113/jphysiol.2010.203364. Epub 2011 Mar 21.

  • Menon RG, Oswald SF, Raghavan P, Regatte RR, Stecco A. T1rho-Mapping for Musculoskeletal Pain Diagnosis: Case Series of Variation of Water Bound Glycosaminoglycans Quantification before and after Fascial Manipulation(R) in Subjects with Elbow Pain. Int J Environ Res Public Health. 2020 Jan 22;17(3):708. doi: 10.3390/ijerph17030708.

  • Valadao P, Cenni F, Piitulainen H, Avela J, Finni T. Effects of the EXECP Intervention on Motor Function, Muscle Strength, and Joint Flexibility in Individuals with Cerebral Palsy. Med Sci Sports Exerc. 2024 Jan 1;56(1):1-12. doi: 10.1249/MSS.0000000000003273. Epub 2023 Aug 7.

  • Te Velde A, Morgan C, Finch-Edmondson M, McNamara L, McNamara M, Paton MCB, Stanton E, Webb A, Badawi N, Novak I. Neurodevelopmental Therapy for Cerebral Palsy: A Meta-analysis. Pediatrics. 2022 Jun 1;149(6):e2021055061. doi: 10.1542/peds.2021-055061.

  • Arumugam K, Harikesavan K. Effectiveness of fascial manipulation on pain and disability in musculoskeletal conditions. A systematic review. J Bodyw Mov Ther. 2021 Jan;25:230-239. doi: 10.1016/j.jbmt.2020.11.005. Epub 2020 Nov 11.

  • Raghavan P, Lu Y, Mirchandani M, Stecco A. Human Recombinant Hyaluronidase Injections For Upper Limb Muscle Stiffness in Individuals With Cerebral Injury: A Case Series. EBioMedicine. 2016 Jul;9:306-313. doi: 10.1016/j.ebiom.2016.05.014. Epub 2016 May 13.

  • Nielsen JB, Christensen MS, Farmer SF, Lorentzen J. Spastic movement disorder: should we forget hyperexcitable stretch reflexes and start talking about inappropriate prediction of sensory consequences of movement? Exp Brain Res. 2020 Aug;238(7-8):1627-1636. doi: 10.1007/s00221-020-05792-0. Epub 2020 May 7.

  • Stecco A, Stern R, Fantoni I, De Caro R, Stecco C. Fascial Disorders: Implications for Treatment. PM R. 2016 Feb;8(2):161-8. doi: 10.1016/j.pmrj.2015.06.006. Epub 2015 Jun 14.

MeSH Terms

Conditions

Cerebral PalsyMuscle Spasticity

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Juha-Pekka Kulmala, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 20, 2025

Study Start

October 4, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations