HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy

NCT07041944 | Not Yet Recruiting DMC

• 2 other identifiers: HEMImprove-APPFEDER
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Unilateral Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Assisting Hand Assessment

  baseline, immediately after the intervention, 3 months after intervention

• Melbourne Assessment v 2.0 MA2

  baseline, immediately after the intervention, 3 months after intervention

• Nine hole Test

  baseline, immediately after the intervention, 3 months after intervention

Secondary Outcomes (2)

• 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

Study Arms (2)

HEMImprove APP

EXPERIMENTAL

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.

Other: HEMImprove APP

Control group

ACTIVE COMPARATOR

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

Other: exercises to upper limb

Interventions

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.

HEMImprove APP

exercises to upper limb OTHER

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

Control group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor will not know the group where the child/adolescent is (experimental or control group)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: June 27, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03