HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy

NCT ID: NCT07041944

Last Updated: 2025-06-27

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-04-01

Brief Summary

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

This study aims to evaluate the effectiveness and usability of HEMImprove 1.0, a gamified mobile application designed to improve upper limb motor function in adolescents with unilateral cerebral palsy. Participants will be randomly assigned to an intervention group using the app or a control group performing conventional home exercises. The intervention will last four weeks, with assessments before and after the intervention to measure motor function, motivation, and quality of life improvements.

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.

Unilateral Cerebral Palsy

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

Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The assessor will not know the group where the child/adolescent is (experimental or control group)

Study Groups

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

HEMImprove APP

Experimental Group:

Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance.

Control Group:

Perform conventional home exercises guided by printed manual with instructions and images, matching frequency and duration of intervention group.

Group Type EXPERIMENTAL

HEMImprove APP

Intervention Type OTHER

Experimental Group:

Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance.

Control Group:

Perform conventional home exercises guided by printed manual with instructions and images, matching frequency and duration of intervention group.

Control group

The control group will do exercises for the same time that is described in the experimental group, without using the APP

Group Type ACTIVE_COMPARATOR

exercises to upper limb

Intervention Type OTHER

The patients will do the same exercises than the experimental group, without APP and using the same dosage

Interventions

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

HEMImprove APP

Experimental Group:

Use HEMImprove 1.0 mobile app at home for 30 minutes/session, 5 days/week, for 4 weeks. Exercises tailored progressively with avatar guidance.

Control Group:

Perform conventional home exercises guided by printed manual with instructions and images, matching frequency and duration of intervention group.

Intervention Type OTHER

exercises to upper limb

The patients will do the same exercises than the experimental group, without APP and using the same dosage

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Adolescents aged 12 to 18 years diagnosed with unilateral cerebral palsy.
* Ability to use the mobile app independently or with minimal assistance.
* Informed consent provided.

Exclusion Criteria

* Severe cognitive impairment.
* Recent upper limb surgery (within 6 months).
* Recent botulinum toxin treatment (within 3 months).
* Other neurological or orthopedic disorders affecting upper limb function.
Minimum Eligible Age

12 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

Other Identifiers

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

FEDER

Identifier Type: OTHER

Identifier Source: secondary_id

HEMImprove-APP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Wereables for Upper Limb Functionality in Hemiparesis
NCT06872736 RECRUITING PHASE2/PHASE3