Physical Therapy for Improving Functionality, Gait and Participation in Cerebral Palsy

NCT04778930 | Unknown

• 1 other identifier: SCosta
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral Palsy is a non-progressive nature lesion of the Central Nervous System, with a wide spectrum of impairments at body structure and function, which has a great impact at activity and participation in the environment. The intensity of participation is influenced by multiple factors, among which independent mobility stands out, through the functional activity of walking. Children and adolescents with Cerebral Palsy present limitations in gait function both at the level of body structure and activity and improving these aspects is one of the main therapeutic objectives in their treatment. Physical Therapy interventions based on task learning and achieving objectives have proven to be effective in improving functional skills, gait and participation. Due to COVID-19, interventions have been interrupted or reduced in periodicity. For this reason, it is essential to provide alternatives to Physical Therapy interventions for children and adolescents with Cerebral Palsy. Telehealth may play an important role both in maintaining function and in monitoring individuals, in addition to bringing the Physical Therapist closer to the natural environment of the child / adolescent through digital platforms. Therefore the aim of this clinical trial is to verify that a Physiotherapy intervention that combines face-to-face sessions with telecare in natural settings is effective in improving the functional activity of walking and participation in the environment of children and adolescents with Cerebral Palsy. The study population are children and adolescents diagnosed with Cerebral Palsy; ages 6-17 years old. The sample of 50 subjects (25 in each group) will be recruited in care centers for children and adolescents with Cerebral Palsy in Alcalá de Henares. The outcome variables are: participation in the environment (Spanish version of the Children's Assessment of Participation and Enjoyment - CAPE), gait speed (10-meter walk test - 10MM), gait endurance (6-minute walk test - 6MM), gross motor function (Spanish version of the Gross Motor Function Measure - GMFM-SP) and static and dynamic balance (Spanish version of the Pediatric Balance Scale - PBS). They will be collected in three moments: baseline assessment (V0); intermediate assessment (V1) at 6 weeks at the end of each group intervention; Final assessment (V2) 3 months after baseline.

Conditions

Physical Therapy; Cerebral Palsy; Therapeutic Education; Telehealth

Keywords

Physical Therapy; Cerebral Palsy; Telehealth; Therapeutic Education

Outcome Measures

Primary Outcomes (5)

• Change in baseline Environmental participation at 6 weeks and 3 months

  Spanish version of Children's Assessment of Participation and Enjoyment (CAPE)

  Baseline assessment

• Change in baseline Gait speed at 6 weeks and 3 months

  10 meter walk Test

  Baseline assessment

• Change in baseline Gait endurance at 6 weeks and 3 months

  6 minutes walk test

  Baseline assessment

• Change in baseline Gross Motor Function at 6 weeks and 3 months

  Spanish version of Gross Motor Function Measure (GMFM-SP)

  Baseline assessment

• Change in baseline Static and Dynamic Balance at 6 weeks and 3 months

  Spanish version of Pediatric Balance Scale (PBS)

  Baseline assessment

Study Arms (2)

Group A_Intervention Group

EXPERIMENTAL

It will consist of 18 sessions, 3 times a week, for 6 consecutive weeks; on the one hand, 12 face-to-face sessions of approximately 90 minutes duration, in which the Physical Therapy treatment will be carried out based on training of specific tasks directed to objectives and training of gait with a treadmill; In addition, a therapeutic education program will be carried out, with 6 telehealth sessions lasting approximately 60 minutes, which will include action observation activities. The face-to-face sessions will be held at the Physical Therapy Teaching Unit at University of Alcalá, and the telehealth sessions of the Therapeutic Education program will be carried out by remote assistance through a digital platform. All will be carried out by specialist Physical Therapists, members of the research team.

Other: Physical Therapy; Other: THERAPEUTIC EDUCATION PROGRAM

Group B_Control Group

EXPERIMENTAL

The subjects in this group will receive their usual Physical Therapy intervention regimen for 6 weeks at their referral center and the same telehealth Therapeutic Education program of the intervention group.

Other: THERAPEUTIC EDUCATION PROGRAM

Interventions

Physical Therapy OTHER

FACE-TO FACE SESSIONS: approximately 90 minutes of Goal-directed training (activities for the activation of the muscles of the trunk, pelvis and lower limbs; and training of activities will be carried out in a functional and meaningful context, aimed at specific functional objectives, according to the interests of each participant and agreed with the participants and their families) and gait training on the treadmill for 20 minutes. TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation.

Also known as: Therapeutic Education, Family centered model, Action Observation Therapy, Goal-directed training, Treadmill

Group A_Intervention Group

THERAPEUTIC EDUCATION PROGRAM OTHER

TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation.

Group A_Intervention Group; Group B_Control Group

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• GMFCS (I-III); MACS (I-III); CFCS (I-III)

You may not qualify if:

• having undergone surgery on lower limbs in the 6 months prior to his participation in the study; having surgery during the study; inability to follow the planned program due to moving to other city or other reason.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (1)

Physiotherapy Neuromusculoskeletal in life stages Research Group - FINEMEV

Alcalá de Henares, Madrid, 28005, Spain

RECRUITING

Related Publications (7)

• Novak I, Morgan C, Fahey M, Finch-Edmondson M, Galea C, Hines A, Langdon K, Namara MM, Paton MC, Popat H, Shore B, Khamis A, Stanton E, Finemore OP, Tricks A, Te Velde A, Dark L, Morton N, Badawi N. State of the Evidence Traffic Lights 2019: Systematic Review of Interventions for Preventing and Treating Children with Cerebral Palsy. Curr Neurol Neurosci Rep. 2020 Feb 21;20(2):3. doi: 10.1007/s11910-020-1022-z.

  PMID: 32086598 RESULT

• Sellier E, McIntyre S, Smithers-Sheedy H, Platt MJ; SCPE and ACPR Groups. European and Australian Cerebral Palsy Surveillance Networks Working Together for Collaborative Research. Neuropediatrics. 2020 Apr;51(2):105-112. doi: 10.1055/s-0039-3402003. Epub 2020 Jan 7.

  PMID: 31910452 RESULT

• Schiariti V, Mahdi S, Bolte S. International Classification of Functioning, Disability and Health Core Sets for cerebral palsy, autism spectrum disorder, and attention-deficit-hyperactivity disorder. Dev Med Child Neurol. 2018 Sep;60(9):933-941. doi: 10.1111/dmcn.13922. Epub 2018 May 30.

  PMID: 29845609 RESULT

• Chakraborty 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.

  PMID: 31677546 RESULT

• Toovey R, Bernie C, Harvey AR, McGinley JL, Spittle AJ. Task-specific gross motor skills training for ambulant school-aged children with cerebral palsy: a systematic review. BMJ Paediatr Open. 2017 Aug 11;1(1):e000078. doi: 10.1136/bmjpo-2017-000078. eCollection 2017.

  PMID: 29637118 RESULT

• Han YG, Yun CK. Effectiveness of treadmill training on gait function in children with cerebral palsy: meta-analysis. J Exerc Rehabil. 2020 Feb 26;16(1):10-19. doi: 10.12965/jer.1938748.374. eCollection 2020 Feb.

  PMID: 32161730 RESULT

• Pacheco-da-Costa S, Rodriguez-Costa I, Abuin-Porras V, Asunsolo-Del-Barco A, Calvo-Fuente V, Soto-Vidal C. Effectiveness of Physiotherapy for Improving Participation, Gross Motor Function, Gait and Balance in Children and Adolescents with Cerebral Palsy: Study Protocol for a Randomized Controlled Trial. J Clin Med. 2025 Mar 24;14(7):2214. doi: 10.3390/jcm14072214.

  PMID: 40217665 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Physical Therapy Modalities; Exercise Test

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Soraya Pacheco da Costa, PhD

  University Professor Physical Therapy Degree

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soraya Pacheco da Costa, PhD

CONTACT

661855923; soraya.pacheco@uah.es

Concepción Soto Vidal, PhD

CONTACT

918854838; conchi.soto@uah.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: As masking techniques, the persons responsible for the assessment of the subjects and the data collection, the random assignment and the intervention in each group will be independent from each other.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 3, 2021
• Study Start: February 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: December 31, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)