Early InterventionNCT07068386
Telerehabilitation for Preterm Infants
A study testing Early intervention with telerehabilitation in people with Early Intervention and Infant, Premature, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants. The motor development of preterm infants will be assessed through video recordings. Read more about this study
- Who is it for?
- Ages 3 months to 1 year
- Conditions the study is for
- Early Intervention, Infant, Premature, Telerehabilitation
- What is being tested?
- Early intervention with telerehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2021to 1 Feb 2024
- 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 3 months to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between November 2021 and May 2024, all preterm infants with a corrected age of 3 to 5 months who were referred to the our Department were invited to participate in the study.
Who cannot join
- Infants with genetic abnormalities, hospitalized infants, those with blindness or deafness, infants requiring respiratory support, and physiologically unstable infants were excluded from the study.
- Additionally, infants whose parents did not have the required technological equipment for telerehabilitation (mobile phone) or the skills to use it were not included in the study.
- Children with optimal MOS-R were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of Telerehabilitation Includes Neuromotor Assessment and Early Intervention for Preterm Infants
The aim of this study is to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants.
The motor development of preterm infants will be assessed through video recordings. Based on these assessments and in collaboration with the parents, an intervention program will be developed. The parents will implement this intervention with their infants over a three-month period. Following this, motor development will be reassessed via video recordings.
- Conditions
- Early Intervention, Infant, Premature, Telerehabilitation
- Being tested
- Early intervention with telerehabilitation
- Keywords
- Early intervention; infant; premature; telerehabilitation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intervention with telerehabilitationOther
All premature infants aged 3 to 5 months included in the study were assessed for motor development using the General Movements Assessment (GMs) and the Alberta Infant Motor Scale (AIMS), based on videos submitted by their parents. Following the video evaluations, parents were contacted via video call. An intervention program was developed in collaboration with the parents, guided by the video-based assessments.
The intervention program focused on the acquisition of age-appropriate motor development and included components such as massage, positioning, trunk control, movement selectivity, and anti-gravity activities. It was delivered to parents through synchronous. Parents were advised to implement the program for 30 minutes per day, 4 days a week, over a 12-week period. After the intervention, the infants were re-evaluated using the AIMS via video call.
| Study group | Role | What they receive |
|---|---|---|
| Infant | Experimental | The study was conducted using a single-arm design to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants. The intervention was individualized for each infant, based on principles of typical motor development, motor learning, and environmental enrichment Receives: Other: Early intervention with telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Optimality Score-Revised (MOS-R) - A numerical result is obtained by observing the spontaneous motor movements, movement pattern, age adequate movement repertoire, postural patterns and movement character of infants.
The infant's spontaneous motor movements in the fidgety period (corrected 3-5 months) are recorded on video for 3-5 minutes. The infant must be active and awake, and no external stimuli should be provided. The MOS-R is made with Gestalt perception on this recording.
MOS-R consists of the sum of five subcategories. Spontaneous motor movements (normal=12, abnormal=4, absent=1 point), movement pattern (normal>abnormal=4, normal=abnormal=2 point, normal<abnormal=1 point), age adequate movement repertoire (present=4, reduced=2, absent=1 point), postural patterns (normal>abnormal=4, normal=abnormal=2, normal<abnormal= 1 point) and movement character (smooth and fluent=4, abnormal=2, cramped synchronized=1 point) The MOS-R ranges from 5 to 28, with higher scores indicating better outcomes. A score between 25 and 28 is considered optimal, 20 to 24 is mildly reduced, 9 to 19 is moderately reduced, and 5 to 8 is severely reduced.
Measured: MOS-R will be administered on Day 1 (baseline). If the baseline MOS-R score is ≤14, the MOS-R will be repeated on Days 8, 15, 22, and 29. If the score is greater than 14, no further MOS-R assessments will be performed.
Alberta Infant Motor Scale (AIMS) - A numerical value is obtained by observing the child's gross motor development in the prone, supine, sitting and standing positions.
It is a norm-referenced tool that evaluates the gross motor development of infants between 0-18 months. This tool evaluates weight transfer, posture and movement against gravity in prone, supine, sitting and standing positions.
The infant receives a score between 0 and 58, depending on age. This score is then converted to a percentile. A higher percentile mean a better outcome.
Measured: AIMS will be administered twice: once at baseline (Day 1) and once 13 weeks after baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start20 Nov 2021
- Primary completion15 Nov 2022
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early InterventionStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysu Kahraman, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068386
- Sponsor's protocol ID
- 2021/219
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the results will be analyzed from the infants' whole body images, it will not be appropriate to share the data.
Publications
Schlichting T, Martins da Silva K, Silva Moreira R, Marques de Moraes MV, Cicuto Ferreira Rocha NA, Boyd RN, Neves Dos Santos A. Telehealth Program for Infants at Risk of Cerebral Palsy during the Covid-19 Pandemic: A Pre-post Feasibility Experimental Study. Phys Occup Ther Pediatr. 2022;42(5):490-509. doi: 10.1080/01942638.2022.2057209. Epub 2022 Mar 27.
PubMed 35341469
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Telerehabilitation Includes Neuromotor Assessment and Early Intervention for Preterm Infants
- ClinicalTrials.gov ID
- NCT07068386
- Acronym / sponsor ID
- 2021/219
- Conditions
- Early Intervention, Infant, Premature, Telerehabilitation
- Keywords
- Early intervention; infant; premature; telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 16 Jul 2025 (actual)
- 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.
The aim of this study is to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants.
The motor development of preterm infants will be assessed through video recordings. Based on these assessments and in collaboration with the parents, an intervention program will be developed. The parents will implement this intervention with their infants over a three-month period. Following this, motor development will be reassessed via video recordings.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infant | Experimental | Other: Early intervention with telerehabilitationThe study was conducted using a single-arm design to investigate the feasibility and short-term effectiveness of early intervention delivered via telerehabilitation on the gross motor development of preterm infants. The intervention was individualized for each infant, based on principles of typical motor development, motor learning, and environmental enrichment |
Who may qualify
- Ages
- 3 months to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Between November 2021 and May 2024, all preterm infants with a corrected age of 3 to 5 months who were referred to the our Department were invited to participate in the study.
Key exclusion criteria (3 listed)
- Infants with genetic abnormalities, hospitalized infants, those with blindness or deafness, infants requiring respiratory support, and physiologically unstable infants were excluded from the study.
- Additionally, infants whose parents did not have the required technological equipment for telerehabilitation (mobile phone) or the skills to use it were not included in the study.
- Children with optimal MOS-R were excluded from the study
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 intervention with telerehabilitationAll premature infants aged 3 to 5 months included in the study were assessed for motor development using the General Movements Assessment (GMs) and the Alberta Infant Motor Scale (AIMS), based on videos submitted by their parents. Following the video evaluations, parents were contacted via video call. An intervention program was developed in collaboration with the parents, guided by the video-based assessments. The intervention program focused on the acquisition of age-appropriate motor development and included components such as massage, positioning, trunk control, movement selectivity, and anti-gravity activities. It was delivered to parents through synchronous. Parents were advised to implement the program for 30 minutes per day, 4 days a week, over a 12-week period. After the intervention, the infants were re-evaluated using the AIMS via video call. | Other | Infant |
Primary outcome
Motor Optimality Score-Revised (MOS-R) - A numerical result is obtained by observing the spontaneous motor movements, movement pattern, age adequate movement repertoire, postural patterns and movement character of infants.
Time frame: MOS-R will be administered on Day 1 (baseline). If the baseline MOS-R score is ≤14, the MOS-R will be repeated on Days 8, 15, 22, and 29. If the score is greater than 14, no further MOS-R assessments will be performed.
The infant's spontaneous motor movements in the fidgety period (corrected 3-5 months) are recorded on video for 3-5 minutes. The infant must be active and awake, and no external stimuli should be provided. The MOS-R is made with Gestalt perception on this recording. MOS-R consists of the sum of five subcategories. Spontaneous motor movements (normal=12, abnormal=4, absent=1 point), movement pattern (normal>abnormal=4, normal=abnormal=2 point, normal<abnormal=1 point), age adequate movement repertoire (present=4, reduced=2, absent=1 point), postural patterns (normal>abnormal=4, normal=abnormal=2, normal<abnormal= 1 point) and movement character (smooth and fluent=4, abnormal=2, cramped synchronized=1 point) The MOS-R ranges from 5 to 28, with higher scores indicating better outcomes. A score between 25 and 28 is considered optimal, 20 to 24 is mildly reduced, 9 to 19 is moderately reduced, and 5 to 8 is severely reduced.
Alberta Infant Motor Scale (AIMS) - A numerical value is obtained by observing the child's gross motor development in the prone, supine, sitting and standing positions.
Time frame: AIMS will be administered twice: once at baseline (Day 1) and once 13 weeks after baseline.
It is a norm-referenced tool that evaluates the gross motor development of infants between 0-18 months. This tool evaluates weight transfer, posture and movement against gravity in prone, supine, sitting and standing positions. The infant receives a score between 0 and 58, depending on age. This score is then converted to a percentile. A higher percentile mean a better outcome.
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 20 Jul 2025.
- Background: PubMed 35341469Schlichting T, Martins da Silva K, Silva Moreira R, Marques de Moraes MV, Cicuto Ferreira Rocha NA, Boyd RN, Neves Dos Santos A. Telehealth Program for Infants at Risk of Cerebral Palsy during the Covid-19 Pandemic: A Pre-post Feasibility Experimental Study. Phys Occup Ther Pediatr. 2022;42(5):490-509. doi: 10.1080/01942638.2022.2057209. Epub 2022 Mar 27.
- Individual participant dataSharing planned: No. Since the results will be analyzed from the infants' whole body images, it will not be appropriate to share the data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention with telerehabilitation in people with Early Intervention and Infant, Premature, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 3 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 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Motor Optimality Score-Revised (MOS-R) - A numerical result is obtained by observing the spontaneous motor movements, movement pattern, age adequate movement repertoire, postural patterns and movement character of infants. (time frame: MOS-R will be administered on Day 1 (baseline). If the baseline MOS-R score is ≤14, the MOS-R will be repeated on Days 8, 15, 22, and 29. If the score is greater than 14, no further MOS-R assessments will be performed.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07068386, which also lists 1 linked publication.
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 20 Jul 2025.