NCT07394985

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Apr 2025Sep 2026

Study Start

First participant enrolled

April 4, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

February 6, 2026

Status Verified

January 1, 2026

Enrollment Period

11 months

First QC Date

January 31, 2026

Last Update Submit

January 31, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Gross Motor Function Measure (GMFM-88)

    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)

    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 Outcomes (1)

  • Canadian Occupational Performance Measure (COPM)

    Baseline and at the end of the 6-month intervention period

Study Arms (2)

Intervention Group

EXPERIMENTAL

telerhabilitation intervention in accordance with neurodevelopmental treatment

Other: neurodevelopmental treatment based on the Bobath concept

Control Group

EXPERIMENTAL

face-to-face intervention in accordance with neurodevelopmental treatment

Other: neurodevelopmental treatment according to the Bobath concept

Interventions

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.

Intervention Group

Participants in the control group continue to receive conventional in-person physiotherapy based on neurodevelopment according to the Bobath concept.

Control Group

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação do Porto de Paralisia Cerebral

Porto, Porto District, 4300-008, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Olga Maria Barros Maia

Study Record Dates

First Submitted

January 31, 2026

First Posted

February 6, 2026

Study Start

April 4, 2025

Primary Completion

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

February 6, 2026

Record last verified: 2026-01

Locations