Physical Therapy Treatment on Children and Adolescents With Neurological Pathologies

NCT ID: NCT05313295

Last Updated: 2023-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2023-05-10

Brief Summary

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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.

Detailed Description

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Conditions

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Neurologic Disorder Duchenne Pediatric Disorder Sensorimotor Disorder Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Home-based Physiotherapy

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

Group Type EXPERIMENTAL

Home-based physiotherapy

Intervention Type OTHER

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

Usual physiotherapy

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

Group Type ACTIVE_COMPARATOR

Usual Physiotherapy

Intervention Type OTHER

Usual care provided for the management of neurological disorders in children

Interventions

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Home-based physiotherapy

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

Intervention Type OTHER

Usual Physiotherapy

Usual care provided for the management of neurological disorders in children

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Other pathological conditions
* Parents refuse the participation on the study
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Almeria

OTHER

Sponsor Role lead

Responsible Party

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María del Mar Sánchez Joya

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María del Mar Sánchez-Joya, PhD

Role: STUDY_CHAIR

Universidad de Almeria

Locations

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María del Mar Sánchez-Joya

Almería, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 25196721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28259452 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28627356 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27737016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23884013 (View on PubMed)

Other Identifiers

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FiNeuro

Identifier Type: -

Identifier Source: org_study_id

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