HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorUniversity of Castilla-La Mancha

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEMImprove APP

    Other intervention

    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.

  • exercises to upper limb

    Other intervention

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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: HEMImprove APPExperimental treatment 1 intervention
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Assisting Hand Assessment

Time frame
baseline, immediately after the intervention, 3 months after intervention
2

Melbourne Assessment v 2.0 MA2

Time frame
baseline, immediately after the intervention, 3 months after intervention
3

Nine hole Test

Time frame
baseline, immediately after the intervention, 3 months after intervention

Secondary outcomes

1

User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention.

Time frame
From the recruitment to the follow-up
2

Qualitative data from semi-structured interviews analyzing user experience.

Time frame
from the recruitment to the end of the treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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