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NCT Number: NCT07091461

HOMe-IMprove Telerrehabilitation System

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.

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Key information

Age range

6 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

  • 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)

Exclusion criteria

  • Severe neurological or psychiatric comorbidities
  • Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)
  • Concurrent participation in other intervention studies

Treatment and study plan

HOME Kit Tablet-based Telerehabilitation

Device

Device-based behavioral intervention (motor, cognitive, and communication rehabilitation)

Conventional Home Physiotherapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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

    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.

  2. Change in individual goal achievement assessed by Goal Attainment Scaling (GAS)

    Time frame: baseline, immediately after the intervention

    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.

  3. 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

    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.

  4. Change in user satisfaction evaluated with a 5-point Likert-scale questionnaire

    Time frame: immediately after the intervention.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rocío Palomo-Carrión, PT PhD

CONTACT

[email protected]

34926051821

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Registry information

Official study title

HOMe-IMprove Telerrehabilitation System for CHilDren With Cerebral Palsy

Acronym: HOMIMTES-CHilD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Feb 5, 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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