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Can remote coaching help At-Risk babies reach milestones?

NCT ID NCT07499843

Disease control Sponsor: Biruni University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two ways of delivering physiotherapy coaching to parents of high-risk infants (born early or with low birth weight) aged 6-9 months. One group gets live video sessions with a therapist, another gets recorded feedback, and a third gets standard home materials. The goal is to see which method best improves motor skills and reduces parenting stress. 48 infants will take part.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
telerehabilitation (parent coaching via video conferencing or video analysis)
What this could lead to
If successful, this could show that remote physiotherapy coaching is as effective as in-person sessions, making early intervention more accessible for at-risk infants.
What could go wrong
This is a small, early-stage trial (48 infants) comparing two remote methods, not testing a new drug or cure. Results may not apply broadly, and the study hasn't started recruiting yet.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 9 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Gestational age ≤32 weeks and/or birth weight ≤1500 grams. * Corrected age between 6 and 9 months at the time of enrollment. * Referral to a pediatric neurology clinic and/or current follow-up by a pediatric neurologist due to developmental risk. * A total score of ≤73 on the Hammersmith Infant Neurological Examination (HINE) (Romeo et al., 2021; Novak et al., 2017). * A score ≤5th percentile on the Alberta Infant Motor Scale (AIMS) (Fuentefria et al., 2017). * Parental willingness to participate and signing of the "Informed Consent Form." * Access to the minimum technological infrastructure required for telerehabilitation (smartphone, tablet, or computer with video calling capability and active internet access). Exclusion Criteria: * Presence of diagnosed genetic syndromes or metabolic diseases known to directly affect neuro-motor development. * Major congenital malformations causing significant movement restriction or exercise intolerance. * History of symptomatic hypoglycemia associated with severe brain injury during the neonatal period. * Sensory impairments (bilateral blindness or severe bilateral hearing loss not correctable with hearing aids) that prevent participation in assessments and exercises based on visual and auditory stimuli. * Acute or unstable clinical conditions that preclude the safe conduct of the intervention (e.g., continuous mechanical ventilation, hemodynamic instability, uncontrolled seizures, or active acute infections). * Non-adherence to the study protocol, defined as missing more than 6 intervention sessions.

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Conditions

The condition(s) this trial relates to.

Premature Birth Psychomotor Disorders

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Motor delay Premature birth of newborn Risky baby

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Biruni University Department of Physiotherapy and Rehabilitation

    Istanbul, Zeyti̇nburnu, 34010, Turkey (Türkiye)

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