HOMe-IMprove Telerrehabilitation System

NCT ID: NCT07091461

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cerebral Palsy Infantile

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HOME Kit Tablet Telerehabilitation

Participants in this arm will receive a structured telerehabilitation program using the HOME Kit Tablet system, which includes a touchscreen tablet with therapeutic software, inertial measurement unit (IMU) sensors, digital scales, a K-wand, and a stabilometric platform. Sessions are remotely supervised in real time by a trained physiotherapist who personalizes the activity protocol according to individual performance.

Group Type EXPERIMENTAL

HOME Kit Tablet-based Telerehabilitation

Intervention Type DEVICE

Device-based behavioral intervention (motor, cognitive, and communication rehabilitation)

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.

Group Type ACTIVE_COMPARATOR

Conventional Home Physiotherapy

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HOME Kit Tablet-based Telerehabilitation

Device-based behavioral intervention (motor, cognitive, and communication rehabilitation)

Intervention Type DEVICE

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rocío Palomo-Carrión, PT PhD

Role: CONTACT

34926051821

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HOMIMTES-CHilD

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Pediatric Teleneuromodulation
NCT05071586 COMPLETED NA
AOT and ICT for Hemiplegia
NCT03094455 COMPLETED NA