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HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy

"Efficacy and Usability of HEMImprove 1.0 Gamified Mobile Application for Upper Limb Rehabilitation in Adolescents With Unilateral Cerebral Palsy: A Randomized Controlled Trial"

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07041944
Acronym
HEMImprove-APP
Enrollment
36
Registered
2025-06-27
Start date
2026-03-01
Completion date
2027-12-01
Last updated
2026-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Cerebral Palsy

Brief summary

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.

Interventions

OTHERHEMImprove 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.

OTHERexercises to upper limb

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

Sponsors

University of Castilla-La Mancha
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Assisting Hand Assessmentbaseline, immediately after the intervention, 3 months after intervention
Melbourne Assessment v 2.0 MA2baseline, immediately after the intervention, 3 months after intervention
Nine hole Testbaseline, immediately after the intervention, 3 months after intervention

Secondary

MeasureTime frame
User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention.From the recruitment to the follow-up
Qualitative data from semi-structured interviews analyzing user experience.from the recruitment to the end of the treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026