Unilateral Cerebral PalsyHEMImprove-APPNCT07041944
HEMImprove 1.0 in Children and Adolescents With Unilateral Cerebral Palsy
A study testing HEMImprove APP and exercises to upper limb in people with Unilateral Cerebral Palsy, run by University of Castilla-La Mancha.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Unilateral Cerebral Palsy
- What is being tested?
- HEMImprove APP and exercises to upper limb
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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"
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
- Being tested
- HEMImprove APP, exercises to upper limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HEMImprove APPOther
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 limbOther
The patients will do the same exercises than the experimental group, without APP and using the same dosage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: exercises to upper limb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assisting Hand Assessment
Measured: baseline, immediately after the intervention, 3 months after intervention
Melbourne Assessment v 2.0 MA2
Measured: baseline, immediately after the intervention, 3 months after intervention
Nine hole Test
Measured: baseline, immediately after the intervention, 3 months after intervention
Secondary outcomes (2)
User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention.
Measured: From the recruitment to the follow-up
Qualitative data from semi-structured interviews analyzing user experience.
Measured: from the recruitment to the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041944
- Sponsor's protocol ID
- HEMImprove-APP
- Other IDs
- FEDER
- Acronym
- HEMImprove-APP
- Status last verified
- Mar 2026
- First submitted
- 10 Jun 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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"
- ClinicalTrials.gov ID
- NCT07041944
- Acronym / sponsor ID
- HEMImprove-APP / HEMImprove-APP
- Conditions
- Unilateral Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HEMImprove APP | Experimental | Other: HEMImprove APPExperimental 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 | Active comparator | Other: exercises to upper limbThe control group will do exercises for the same time that is described in the experimental group, without using the APP |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HEMImprove APPExperimental 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 |
| exercises to upper limbThe patients will do the same exercises than the experimental group, without APP and using the same dosage | Other | Control group |
Primary outcome
Assisting Hand Assessment
Time frame: baseline, immediately after the intervention, 3 months after intervention
Melbourne Assessment v 2.0 MA2
Time frame: baseline, immediately after the intervention, 3 months after intervention
Nine hole Test
Time frame: baseline, immediately after the intervention, 3 months after intervention
2 secondary outcomes
User satisfaction and usability measured through structured Likert-scale questionnaires post-intervention.
Time frame: From the recruitment to the follow-up
Qualitative data from semi-structured interviews analyzing user experience.
Time frame: from the recruitment to the end of the treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HEMImprove APP and exercises to upper limb in people with Unilateral Cerebral Palsy, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assisting Hand Assessment (time frame: baseline, immediately after the intervention, 3 months after intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.