Fiability of a Telerehabilitation Programme Based on the Neurodevelopmental Treatment (NDT) Model on Gross Motor Function and Functional Performance in Children With Cerebral Palsy.

January 31, 2026 updated by: Olga Maria Barros Maia, Escola Superior Saúde Fernando Pessoa
Experimental study with a control group, developed with the aim of analyzing the impact of a telerehabilitation program based on the Neurodevelopmental Treatment (NDT) model on gross motor function and functional performance in children with cerebral palsy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The sample consisted of 20 children divided into two equivalent groups: an experimental group (n = 10), which received the TND intervention program in a synchronous telerehabilitation format for six months, and a control group (n = 10), which maintained the usual care and clinical follow-up plan without additional structured intervention.

The children included had a clinical diagnosis of spastic cerebral palsy, aged between 6 months and 6 years, classified between levels I and IV of the Gross Motor Function Classification System (GMFCS).

The pre-intervention assessment was performed before the start of the program, and the post-intervention assessment took place after six months. The assessments included the GMFM-88, to measure gross motor function, and the CO-OP Performance Measure (COOPM), to assess caregivers' perceptions of performance and satisfaction.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
    • Porto District
      • Porto, Porto District, Portugal, 4300-008
        • Associação do Porto de Paralisia Cerebral

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion criteria Confirmed diagnosis of cerebral palsy; Age between 6 months and 6 years; Ability of the primary caregiver to actively participate in online sessions; Regular access to a device with a camera and internet connection.

Exclusion criteria Orthopaedic surgery or botulinum toxin application in the six months prior to the intervention; Presence of severe comorbidities (cardiorespiratory, cognitive, or sensory) that would limit participation;

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
telerhabilitation intervention in accordance with neurodevelopmental treatment
Other: neurodevelopmental treatment based on the Bobath concept
Participants in the intervention group receive a structured telerehabilitation program based on neurodevelopmental principles. The intervention is delivered remotely by a physiotherapist through scheduled sessions and focuses on improving motor control, postural alignment, balance, and functional movement according to each child's abilities. The program is individualized and adapted to the functional level of each participant and is conducted over a predefined intervention period.
Experimental: Control Group
face-to-face intervention in accordance with neurodevelopmental treatment
Other: neurodevelopmental treatment according to the Bobath concept
Participants in the control group continue to receive conventional in-person physiotherapy based on neurodevelopment according to the Bobath concept.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gross Motor Function Measure (GMFM-88)
Time Frame: Baseline and at the end of the 6-month intervention period
instrument designed to evaluate changes in gross motor abilities in children with cerebral palsy.
Baseline and at the end of the 6-month intervention period
Gross Motor Function Measure (GMFM-88)
Time Frame: Baseline and at the end of the 6-month intervention period
Gross motor function assessed using the Gross Motor Function Measure-88 (GMFM-88), a validated observational instrument designed to evaluate changes in gross motor abilities in children with cerebral palsy.
Baseline and at the end of the 6-month intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline and at the end of the 6-month intervention period
Occupational performance and satisfaction assessed using the Canadian Occupational Performance Measure (COPM), administered to the child's primary caregiver as a proxy respondent. Caregivers identify meaningful daily activities and rate the child's performance and satisfaction on a 10-point scale. Changes from baseline to post-intervention are analyzed.
Baseline and at the end of the 6-month intervention period

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Escola Superior Saúde Fernando Pessoa

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 4, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESTUDO_PC_TELEREAB_01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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