Problem With Growth of an InfantInfantNCT02681289
Physiotherapy of At-Risk Infants, Physiotherapist or Family?
A study testing Early goal directed neuromotor therapy in people with Problem With Growth of an Infant, run by Hacettepe University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 15 months
- Conditions the study is for
- Problem With Growth of an Infant
- What is being tested?
- Early goal directed neuromotor therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
- lack of informed content by the parents.
About this study
Official title: 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.
Read the 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).
- Conditions
- Problem With Growth of an Infant
- Being tested
- Early goal directed neuromotor therapy
- Keywords
- infant, risk, rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early goal directed neuromotor therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| physiotherapy group | Experimental | Early goal directed neuromotor therapy applied by physiotherapist Receives: Other: Early goal directed neuromotor therapy |
| family group | Experimental | Early goal directed neuromotor therapy applied by family Receives: Other: Early goal directed neuromotor therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hammersmith Infant Neurological Examination (HINE)
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.
Measured: 12 weeks
Alberta Infant Motor Scale (AIMS)
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.
Measured: 12 weeks
Goal Attainment Scale (GAS)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem With Growth of an InfantStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Nilay Comuk Balci, Hacettepe University
- Investigators
- Mintaze Kerem Gunel, PT, PhD, Study director, Hacettepe UniversityZafer Erden, PT, PhD, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681289
- Sponsor's protocol ID
- GO13 186-01
- Acronym
- Infant
- Status last verified
- Feb 2016
- First submitted
- 7 Feb 2016
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy of At-Risk Infants, Physiotherapist or Family? A Randomized Intervention Study
- ClinicalTrials.gov ID
- NCT02681289
- Acronym / sponsor ID
- Infant / GO13 186-01
- Conditions
- Problem With Growth of an Infant
- Keywords
- infant, risk, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physiotherapy group | Experimental | Other: Early goal directed neuromotor therapyEarly goal directed neuromotor therapy applied by physiotherapist |
| family group | Experimental | Other: Early goal directed neuromotor therapyEarly goal directed neuromotor therapy applied by family |
Who may qualify
- Ages
- Up to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- having congenital anomalies, musculoskeletal disorders, cyanotic congenital heart disease and mechanical dependency, and
- lack of informed content by the parents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early goal directed neuromotor therapyEarly 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. | Other | family group, physiotherapy group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2016.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mintaze Kerem Gunel, PT, PhD study director
Hacettepe University
Zafer Erden, PT, PhD study director
Hacettepe University
Questions about this trial
What is this clinical trial studying?
A study testing Early goal directed neuromotor therapy in people with Problem With Growth of an Infant, run by Hacettepe University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hammersmith Infant Neurological Examination (HINE) (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2016.