- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394985
Fiability of a Telerehabilitation Programme Based on the Neurodevelopmental Treatment (NDT) Model on Gross Motor Function and Functional Performance in Children With Cerebral Palsy.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Porto District
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Porto, Porto District, Portugal, 4300-008
- Associação do Porto de Paralisia Cerebral
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
telerhabilitation intervention in accordance with neurodevelopmental treatment
|
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
|
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
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- ESTUDO_PC_TELEREAB_01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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