Physiotherapy of At-Risk Infants, Physiotherapist or Family?

NCT ID: NCT02681289

Last Updated: 2016-02-12

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-12-31

Brief Summary

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Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants.

Detailed Description

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Early physiotherapy reduces neuromotor problems in at-risk infants. This study was planned to compare the effects of an early goal-directed neuromotor physiotherapy (GDNT) application between preterm and term at-risk infants. Eighteen at-risk infants between the ages of 0 and 12 months were assigned to the preterm and term groups according to their gestational and corrected age. Each group received GDNT for 45 min, three days per week for 12 weeks. The effectiveness of the therapy was measured using Alberta Infant Motor Scale (AIMS), Hammersmith Infant Neurological Examination (HINE), and Goal Attainment Scale (GAS).

Conditions

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Problem With Growth of an Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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physiotherapy group

Early goal directed neuromotor therapy applied by physiotherapist

Group Type EXPERIMENTAL

Early goal directed neuromotor therapy

Intervention Type OTHER

Early goal directed neuromotor therapy (NGDT) is referred to as 'task-oriented' and is built on contemporary system theories of motor control. The development and learning of new skills occur in an interaction between the child, the task to be performed and the particular environment in which the activity takes place.

family group

Early goal directed neuromotor therapy applied by family

Group Type EXPERIMENTAL

Early goal directed neuromotor therapy

Intervention Type OTHER

Early goal directed neuromotor therapy (NGDT) is referred to as 'task-oriented' and is built on contemporary system theories of motor control. The development and learning of new skills occur in an interaction between the child, the task to be performed and the particular environment in which the activity takes place.

Interventions

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Early goal directed neuromotor therapy

Early goal directed neuromotor therapy (NGDT) is referred to as 'task-oriented' and is built on contemporary system theories of motor control. The development and learning of new skills occur in an interaction between the child, the task to be performed and the particular environment in which the activity takes place.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* being diagnosed as "at-risk" by a pediatric neurologist, having intraventricular hemorrhage, periventricular leucomalacia, hypoxic ischemic encephalopathy, and prematurity, Apgar score of 5 or less at 5 min, chronic lung disease, seizures, meningitis, hyperbilirubinemia, being twins or triplets, and having intrauterine growth restriction;
* being outside of the neonatal intensive care unit;
* being between 0 and 12 months old (corrected age for premature infants);
* having a family acceptance for the participation in 12 weeks of therapy program.

Exclusion Criteria

* having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
* lack of informed content by the parents.
Maximum Eligible Age

15 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Nilay Comuk Balci

Pt, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mintaze Kerem Gunel, PT, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Zafer Erden, PT, PhD

Role: STUDY_DIRECTOR

Hacettepe University

Other Identifiers

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GO13 186-01

Identifier Type: -

Identifier Source: org_study_id

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