Cerebral Palsy InfantileHOMIMTES-CHilDNCT07091461
HOMe-IMprove Telerrehabilitation System
A study testing HOME Kit Tablet-based Telerehabilitation and Conventional Home Physiotherapy in people with Cerebral Palsy Infantile, run by University of Castilla-La Mancha.
Trial summary
This pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy Infantile
- What is being tested?
- HOME Kit Tablet-based Telerehabilitation and Conventional Home Physiotherapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2026to 1 Apr 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Confirmed diagnosis of infantile unilateral cerebral palsy
- Age between 6 and 18 years
- Stable home Wi-Fi access and space to perform exercises
- Manual Ability Classification System (MACS) level ≤ 3
- Informed consent from legal guardian and assent from the child (if <12 years)
Who cannot join
- Severe neurological or psychiatric comorbidities
- Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)
- Concurrent participation in other intervention studies
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HOMe-IMprove Telerrehabilitation System for CHilDren With Cerebral Palsy
This pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. The intervention group will use a digitally supervised rehabilitation system, while the control group will follow a traditional home therapy protocol without technological tools.
- Conditions
- Cerebral Palsy Infantile
- Being tested
- HOME Kit Tablet-based Telerehabilitation, Conventional Home Physiotherapy
- Keywords
- home, children, infantile cerebral palsy, family, upper extremity, balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOME Kit Tablet-based TelerehabilitationDevice
Device-based behavioral intervention (motor, cognitive, and communication rehabilitation)
Conventional Home PhysiotherapyOther
Participants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns.
| Study group | Role | What they receive |
|---|---|---|
| HOME Kit Tablet Telerehabilitation | Experimental | Participants in this arm will receive a structured telerehabilitation program using the HOME Kit Tablet system, which includes a touchscreen tablet with therapeutic software, inertial measurement unit (IMU) sensors, digital scales, a K-wand, and a stabilometric platform. Sessions are remotely supervised in real time by a trained physiotherapist who personalizes the activity protocol according to individual performance. Receives: Device: HOME Kit Tablet-based Telerehabilitation |
| Conventional Home Physiotherapy | Active comparator | Participants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns. Receives: Other: Conventional Home Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postural control assessed by stabilometric platform
Postural control is evaluated using a stabilometric platform, which quantitatively measures center of pressure (CoP) displacement and sway area during quiet standing. The main outcome is the mean sway area in square centimeters (cm²), with lower values indicating better postural stability.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in balance performance assessed by the Pediatric Berg Balance Scale (PBS)
The PBS is a 14-item observational tool designed to measure balance in children. Scores range from 0 to 56; higher scores indicate better balance function.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in unimanual hand function assessed by the Assisting Hand Assessment (AHA)
The AHA measures how effectively children with unilateral cerebral palsy use their affected hand in bimanual tasks. Total scores range from 0 to 100; higher scores indicate better hand function.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in upper limb performance assessed by the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)
The SHUEE evaluates spontaneous and dynamic use of the upper limb. Scores range from 0 to 100; higher scores indicate better function.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in manual ability assessed by the Children's Hand-use Experience Questionnaire (CHEQ)
The CHEQ is a parent-reported measure that assesses the child's experience using their affected hand in daily tasks. Item scores and mean summary scores; higher scores reflect better experiences.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in gross manual dexterity assessed by the Box and Block Test
The Box and Block Test assesses gross manual dexterity by counting the number of blocks moved from one compartment to another in one minute. Higher numbers indicate better manual dexterity.
Measured: baseline, immediately after the intervention, 1 month after intervention
Secondary outcomes (4)
Change in participation in daily activities assessed by the Participation and Environment Measure for Children and Youth (PEM-CY)
The PEM-CY questionnaire evaluates participation frequency, involvement, and environmental supports and barriers across home, school, and community settings in children and youth. Scores are reported as frequency (number of activities per week), level of involvement (1-5 scale), and percentage of environmental barriers identified. Higher scores in frequency and involvement indicate greater participation, while higher percentages of environmental barriers reflect more challenges. Outcomes will be summarized for each domain (home, school, community) separately.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in individual goal achievement assessed by Goal Attainment Scaling (GAS)
Goal Attainment Scaling (GAS) is a participant-centered outcome measure that evaluates the extent to which individualized rehabilitation goals are achieved. Each participant collaborates with the therapist to set specific goals at baseline, which are rated on a 5-point scale ranging from -2 (much less than expected outcome) to +2 (much more than expected outcome), with 0 representing the expected level of achievement. Higher total GAS scores reflect greater goal attainment and better functional improvement.
Measured: baseline, immediately after the intervention
Change in occupational performance and satisfaction assessed by the Canadian Occupational Performance Measure (COPM)
The COPM measures self-perceived performance and satisfaction in daily activities identified as important by the participant or caregiver. Participants rate their performance and satisfaction on a 10-point scale (1-10), with higher scores indicating better performance and greater satisfaction. The primary outcomes are changes in COPM performance and satisfaction scores between baseline and post-intervention assessments.
Measured: baseline, immediately after the intervention, 1 month after intervention
Change in user satisfaction evaluated with a 5-point Likert-scale questionnaire
User satisfaction with the intervention will be assessed using a structured questionnaire based on a 5-point Likert scale, ranging from 1 (very dissatisfied) to 5 (very satisfied). The total score will be calculated as the mean of individual item responses. Higher scores indicate greater satisfaction with the rehabilitation protocol and the HOME Kit system. The questionnaire includes items related to usability, comfort, perceived usefulness, and motivation.
Measured: immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start1 Mar 2026 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy InfantileStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 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
- NCT07091461
- Sponsor's protocol ID
- HOMIMTES-CHilD
- Acronym
- HOMIMTES-CHilD
- Status last verified
- Feb 2026
- First submitted
- 7 Jul 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOMe-IMprove Telerrehabilitation System for CHilDren With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07091461
- Acronym / sponsor ID
- HOMIMTES-CHilD / HOMIMTES-CHilD
- Conditions
- Cerebral Palsy Infantile
- Keywords
- home, children, infantile cerebral palsy, family, upper extremity, balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 29 Jul 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 pilot study aims to assess the feasibility, adherence, and preliminary efficacy of a home-based telerehabilitation protocol using the HOME Kit Tablet system in children aged 6 to 18 years with cerebral palsy. The study follows a randomized controlled design with parallel groups and single-blind evaluation. The intervention group will use a digitally supervised rehabilitation system, while the control group will follow a traditional home therapy protocol without technological tools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HOME Kit Tablet Telerehabilitation | Experimental | Device: HOME Kit Tablet-based TelerehabilitationParticipants in this arm will receive a structured telerehabilitation program using the HOME Kit Tablet system, which includes a touchscreen tablet with therapeutic software, inertial measurement unit (IMU) sensors, digital scales, a K-wand, and a stabilometric platform. Sessions are remotely supervised in real time by a trained physiotherapist who personalizes the activity protocol according to individual performance. |
| Conventional Home Physiotherapy | Active comparator | Other: Conventional Home PhysiotherapyParticipants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of infantile unilateral cerebral palsy
- Age between 6 and 18 years
- Stable home Wi-Fi access and space to perform exercises
- Manual Ability Classification System (MACS) level ≤ 3
- Informed consent from legal guardian and assent from the child (if <12 years)
Key exclusion criteria (3 listed)
- Severe neurological or psychiatric comorbidities
- Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)
- Concurrent participation in other intervention studies
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 |
|---|---|---|
| HOME Kit Tablet-based TelerehabilitationDevice-based behavioral intervention (motor, cognitive, and communication rehabilitation) | Device | HOME Kit Tablet Telerehabilitation |
| Conventional Home PhysiotherapyParticipants in this arm will follow a conventional home rehabilitation protocol, focusing on upper limb function and postural control. The protocol includes traditional exercises prescribed and explained by a physiotherapist. Follow-up will be conducted through weekly phone calls to reinforce adherence and resolve concerns. | Other | Conventional Home Physiotherapy |
Primary outcome
Change in postural control assessed by stabilometric platform
Time frame: baseline, immediately after the intervention, 1 month after intervention
Postural control is evaluated using a stabilometric platform, which quantitatively measures center of pressure (CoP) displacement and sway area during quiet standing. The main outcome is the mean sway area in square centimeters (cm²), with lower values indicating better postural stability.
Change in balance performance assessed by the Pediatric Berg Balance Scale (PBS)
Time frame: baseline, immediately after the intervention, 1 month after intervention
The PBS is a 14-item observational tool designed to measure balance in children. Scores range from 0 to 56; higher scores indicate better balance function.
Change in unimanual hand function assessed by the Assisting Hand Assessment (AHA)
Time frame: baseline, immediately after the intervention, 1 month after intervention
The AHA measures how effectively children with unilateral cerebral palsy use their affected hand in bimanual tasks. Total scores range from 0 to 100; higher scores indicate better hand function.
Change in upper limb performance assessed by the Shriners Hospital for Children Upper Extremity Evaluation (SHUEE)
Time frame: baseline, immediately after the intervention, 1 month after intervention
The SHUEE evaluates spontaneous and dynamic use of the upper limb. Scores range from 0 to 100; higher scores indicate better function.
Change in manual ability assessed by the Children's Hand-use Experience Questionnaire (CHEQ)
Time frame: baseline, immediately after the intervention, 1 month after intervention
The CHEQ is a parent-reported measure that assesses the child's experience using their affected hand in daily tasks. Item scores and mean summary scores; higher scores reflect better experiences.
Change in gross manual dexterity assessed by the Box and Block Test
Time frame: baseline, immediately after the intervention, 1 month after intervention
The Box and Block Test assesses gross manual dexterity by counting the number of blocks moved from one compartment to another in one minute. Higher numbers indicate better manual dexterity.
4 secondary outcomes
Change in participation in daily activities assessed by the Participation and Environment Measure for Children and Youth (PEM-CY)
Time frame: baseline, immediately after the intervention, 1 month after intervention
Change in individual goal achievement assessed by Goal Attainment Scaling (GAS)
Time frame: baseline, immediately after the intervention
Change in occupational performance and satisfaction assessed by the Canadian Occupational Performance Measure (COPM)
Time frame: baseline, immediately after the intervention, 1 month after intervention
Change in user satisfaction evaluated with a 5-point Likert-scale questionnaire
Time frame: immediately after the intervention.
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 5 Feb 2026.
Related trials for Cerebral Palsy Infantile
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruiting
Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
Cerebral Palsy, Hemiplegia, Infantile
Not yet recruiting
Coaching, Learning, Empowerment in Cerebral Palsy - a 6-Week Integrated PT/OT Caregiver "Primer" Bootcamp for Infants Diagnosed With or at High Risk for Cerebral Palsy
Cerebral Palsy, Cerebral Palsy (CP)
RecruitingObservational study
Motor-voice Assessment in Infants (MAMI)
Cerebral Palsy Infantile, Pre-Term
RecruitingObservational study
Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disorders
Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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.
Questions about this trial
What is this clinical trial studying?
A study testing HOME Kit Tablet-based Telerehabilitation and Conventional Home Physiotherapy in people with Cerebral Palsy Infantile, 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 5 inclusion and 3 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 5 Feb 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?
Contact Rocío Palomo-Carrión, PT PhD (34926051821, Rocio.Palomo@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postural control assessed by stabilometric platform (time frame: baseline, immediately after the intervention, 1 month after intervention). The study lists 6 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 5 Feb 2026.