Cerebral Palsy ChildrenNCT07394985
Fiability of a Telerehabilitation Programme Based on the Neurodevelopmental Treatment (NDT) Model on Gross Motor Function and Functional Performance in Children With Cerebral Palsy.
A study testing neurodevelopmental treatment based on the Bobath concept and neurodevelopmental treatment according to the Bobath concept in people with Cerebral Palsy Children, run by Escola Superior Saúde Fernando Pessoa at 1 site in Portugal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Cerebral Palsy Children
- What is being tested?
- neurodevelopmental treatment based on the Bobath concept and neurodevelopmental treatment according to the Bobath concept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePortugal
- Study dates
- 4 Apr 2025to 1 Sep 2026
- Phase
- Interventional
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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
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;
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Associação do Porto de Paralisia Cerebral
Porto, Porto District, 4300-008
About this study
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.
Read the 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.
- Conditions
- Cerebral Palsy Children
- Being tested
- neurodevelopmental treatment based on the Bobath concept, neurodevelopmental treatment according to the Bobath concept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
neurodevelopmental treatment based on the Bobath conceptOther
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.
neurodevelopmental treatment according to the Bobath conceptOther
Participants in the control group continue to receive conventional in-person physiotherapy based on neurodevelopment according to the Bobath concept.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | telerhabilitation intervention in accordance with neurodevelopmental treatment Receives: Other: neurodevelopmental treatment based on the Bobath concept |
| Control Group | Experimental | face-to-face intervention in accordance with neurodevelopmental treatment Receives: Other: neurodevelopmental treatment according to the Bobath concept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM-88)
instrument designed to evaluate changes in gross motor abilities in children with cerebral palsy.
Measured: Baseline and at the end of the 6-month intervention period
Gross Motor Function Measure (GMFM-88)
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.
Measured: Baseline and at the end of the 6-month intervention period
Secondary outcomes (1)
Canadian Occupational Performance Measure (COPM)
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.
Measured: Baseline and at the end of the 6-month intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start4 Apr 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy ChildrenStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a parallel-group experimental study in which participants are assigned to an intervention group or a control group. The intervention group undergoes a structured telerehabilitation program based on neurodevelopmental principles, while the control group continues with usual care. Outcome measures are collected at baseline and post-intervention to assess changes within each group over time.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior Saúde Fernando Pessoa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Maria Barros Maia, Escola Superior Saúde Fernando Pessoa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07394985
- Sponsor's protocol ID
- ESTUDO_PC_TELEREAB_01
- Status last verified
- Jan 2026
- First submitted
- 31 Jan 2026
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No