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Not yet recruiting NCT07091461

HOMe-IMprove Telerrehabilitation System

No phase Interventional Cerebral Palsy Infantile

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HOME Kit Tablet-based Telerehabilitation, Conventional Home Physiotherapy.
Who it may be relevant to
Registry conditions: Cerebral Palsy Infantile. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

HOMe-IMprove Telerrehabilitation System for CHilDren With Cerebral Palsy

Overview

This pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. The intervention group will use a digitally supervised rehabilitation system, while the control group will follow a traditional home therapy protocol without technological tools.

Interventions

  • Device HOME Kit Tablet-based Telerehabilitation
    Device-based behavioral intervention (motor, cognitive, and communication rehabilitation)
  • Other Conventional Home Physiotherapy
    Participants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns.

Primary outcome measures

  • Change in postural control assessed by stabilometric platform [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in balance performance assessed by the Pediatric Berg Balance Scale (PBS) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in unimanual hand function assessed by the Assisting Hand Assessment (AHA) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in upper limb performance assessed by the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in manual ability assessed by the Children's Hand-use Experience Questionnaire (CHEQ) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in gross manual dexterity assessed by the Box and Block Test [Time frame: baseline, immediately after the intervention, 1 month after intervention]
Secondary outcome measures (4)
  • Change in participation in daily activities assessed by the Participation and Environment Measure for Children and Youth (PEM-CY) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in individual goal achievement assessed by Goal Attainment Scaling (GAS) [Time frame: baseline, immediately after the intervention]
  • Change in occupational performance and satisfaction assessed by the Canadian Occupational Performance Measure (COPM) [Time frame: baseline, immediately after the intervention, 1 month after intervention]
  • Change in user satisfaction evaluated with a 5-point Likert-scale questionnaire [Time frame: immediately after the intervention.]

Eligibility criteria

Inclusion criteria

  • Confirmed diagnosis of infantile unilateral cerebral palsy
  • Age between 6 and 18 years
  • Stable home Wi-Fi access and space to perform exercises
  • Manual Ability Classification System (MACS) level ≤ 3
  • Informed consent from legal guardian and assent from the child (if <12 years)

Exclusion criteria

  • Severe neurological or psychiatric comorbidities
  • Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)
  • Concurrent participation in other intervention studies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07091461 · HOMIMTES-CHilD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗