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NCT Number: NCT07041944

HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy

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.

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Key information

Conditions

Unilateral Cerebral Palsy

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HEMImprove APP

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.

exercises to upper limb

Other

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

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

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

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

Acronym: HEMImprove-APP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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