Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies

NCT05313295 | Completed DMC

• 1 other identifier: FiNeuro
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the positive effects of a home-based physical therapy intervention added to the usual physical therapy programs performed in children with neurological pathologies that induce sensorimotor impairments that affect their quality of life and the importance of the implications of their families in their treatment.

Conditions

Neurologic Disorder; Duchenne; Pediatric Disorder; Sensorimotor Disorder Nos

Keywords

Childhood; Neurologic disorder; Duchenne

Outcome Measures

Primary Outcomes (1)

• Motor Function Measure

  Measurement scale for motor function applied to neuromuscular diseases (MFM): It was created in France in order to perform a better evaluation of global motor function in patients with Duchenne's muscular dystrophy (DMD), both for ambulatory and non-ambulatory patients. It has two versions, MFM 20 for children under 6 years of age and MFM 32 for children over 6 years of age. The scale considers three dimensions: (D1) standing station and transfers; (D2) axial and proximal motor skills and (D3) distal motor skills. The sum of the three results in a global percentage that provides an updated overview of the patient's functional diagnosis. (Trundell et al., 2020)

  One Year

Secondary Outcomes (4)

• Brooke Upper Extremity Scale

  One Year

• Vignos Scale

  One Year

• Timed Up and Go Test

  One Year

• Six Minutes Walk Distance

  One Year

Study Arms (2)

Home-based Physiotherapy

EXPERIMENTAL

Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques) + 3 hours extra of home-based physiotherapy (stretching, active mobilizations)

Other: Home-based physiotherapy

Usual physiotherapy

ACTIVE COMPARATOR

Two days a week of physical therapy (mobilizations, manual therapy, stretching, respiratory techniques)

Other: Usual Physiotherapy

Interventions

Home-based physiotherapy OTHER

Manual Therapy, passive and active mobilizations, stretching, respiratory techniques

Home-based Physiotherapy

Usual Physiotherapy OTHER

Usual care provided for the management of neurological disorders in children

Usual physiotherapy

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Parents agree to include their children on the study
• Affiliated to the Duchenne Parents Project Association (Spain)
• Between 3-18 years old

You may not qualify if:

• Other pathological conditions
• Parents refuse the participation on the study

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

María del Mar Sánchez-Joya

Almería, 04120, Spain

Location

Related Publications (5)

• Alemdaroglu I, Karaduman A, Yilmaz OT, Topaloglu H. Different types of upper extremity exercise training in Duchenne muscular dystrophy: effects on functional performance, strength, endurance, and ambulation. Muscle Nerve. 2015 May;51(5):697-705. doi: 10.1002/mus.24451. Epub 2015 Mar 5.

  PMID: 25196721 BACKGROUND

• Alkan H, Mutlu A, Firat T, Bulut N, Karaduman AA, Yilmaz OT. Effects of functional level on balance in children with Duchenne Muscular Dystrophy. Eur J Paediatr Neurol. 2017 Jul;21(4):635-638. doi: 10.1016/j.ejpn.2017.02.005. Epub 2017 Feb 20.

  PMID: 28259452 BACKGROUND

• Hind D, Parkin J, Whitworth V, Rex S, Young T, Hampson L, Sheehan J, Maguire C, Cantrill H, Scott E, Epps H, Main M, Geary M, McMurchie H, Pallant L, Woods D, Freeman J, Lee E, Eagle M, Willis T, Muntoni F, Baxter P. Aquatic therapy for children with Duchenne muscular dystrophy: a pilot feasibility randomised controlled trial and mixed-methods process evaluation. Health Technol Assess. 2017 May;21(27):1-120. doi: 10.3310/hta21270.

  PMID: 28627356 BACKGROUND

• Goemans N, Vanden Hauwe M, Signorovitch J, Swallow E, Song J; Collaborative Trajectory Analysis Project (cTAP). Individualized Prediction of Changes in 6-Minute Walk Distance for Patients with Duchenne Muscular Dystrophy. PLoS One. 2016 Oct 13;11(10):e0164684. doi: 10.1371/journal.pone.0164684. eCollection 2016.

  PMID: 27737016 BACKGROUND

• Jansen M, van Alfen N, Geurts AC, de Groot IJ. Assisted bicycle training delays functional deterioration in boys with Duchenne muscular dystrophy: the randomized controlled trial "no use is disuse". Neurorehabil Neural Repair. 2013 Nov-Dec;27(9):816-27. doi: 10.1177/1545968313496326. Epub 2013 Jul 24.

  PMID: 23884013 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Muscular Dystrophy, Duchenne

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• María del Mar Sánchez-Joya, PhD

  Universidad de Almeria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: April 6, 2022
• Study Start: November 1, 2018
• Primary Completion: November 30, 2022
• Study Completion: May 10, 2023
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will become available for one year once the study is finished
• Access Criteria: Reasonable request to reproduce the intervention performed on this study

Locations

ES (1)