Physiotherapy of At-Risk Infants, Physiotherapist or Family? (Infant)

February 11, 2016 updated by: Nilay Comuk Balci, Hacettepe University

Physiotherapy of At-Risk Infants, Physiotherapist or Family? A Randomized Intervention Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: physiotherapy group
Early goal directed neuromotor therapy applied by physiotherapist
Other: 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.
Experimental: family group
Early goal directed neuromotor therapy applied by family
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hammersmith Infant Neurological Examination (HINE)
Time Frame: 12 weeks
It includes three sections, the Neurological Examination, the Development of Motor Functions and the State of Behaviour.The data obtained in the second and third sections are not included in the calculation of global optimality scores. The overall score ranges from a minimum of 0 to a maximum of 78. At 9 or 12 months, the scores equal or above 73 are regarded as optimal, if below 73 as sub-optimal; while at 3 and 6 months healthy term infants scored equal or above 67 and 70 (median) respectively.
12 weeks
Alberta Infant Motor Scale (AIMS)
Time Frame: 12 weeks
This scale is a norm-referenced observational tool designed for the evaluation of gross motor development in infants from birth to 18 months of age or the acquisition of independent walking. It consists of 58 items and four subscales: supine (9 items), prone (21 items), sitting (12 items) and standing (16 items), which are observed in postural alignment, antigravity movements and surface contact.The obtained score (0-60 points) was converted to a normative age-dependent percentile rank (5th,10th,25th, 50th, 75th or 90th percentiles). A score less than the 10th percentile was classified as possibly delayed motor development.
12 weeks
Goal Attainment Scale (GAS)
Time Frame: 12 weeks
GAS methods required practitioners to set rehabilitation goals in collaboration with the client and family. or significant others, such as a carer. For each goal, the client and practitioner developed detailed and very specific observable and quantifiable descriptions of possible outcomes Five outcome levels were identified,including the expected or desired level of performance or outcome, 2 levels that would be seen as less favourable and 2 levels that were more favourable. The 5 recommended outcome levels for each goal were assigned numeric values from -2 (the least favourable outcome) to +2 (the most favourable outcome). The expected outcome or goal was assigned 0.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

The Scientific and Technological Research Council of Turkey

Investigators

  • Study Director: Mintaze Kerem Gunel, PT, PhD, Hacettepe University
  • Study Director: Zafer Erden, PT, PhD, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 7, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GO13 186-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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