HOMe-IMprove Telerrehabilitation System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity of Castilla-La Mancha

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe neurological or psychiatric comorbidities

Recent orthopedic surgery (<12 months) or botulinum toxin treatment (<6 months)

Concurrent participation in other intervention studies

Trial design

Design model

Parallel

Treatments tested in this trial

  • HOME Kit Tablet-based Telerehabilitation

    Device

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

  • Conventional Home Physiotherapy

    Other intervention

    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.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: HOME Kit Tablet TelerehabilitationExperimental treatment 1 intervention
Group B: Conventional Home PhysiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention
2

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention
3

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention
4

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention

Secondary outcomes

1

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention
2

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.

Time frame
baseline, immediately after the intervention
3

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.

Time frame
baseline, immediately after the intervention, 1 month after intervention
4

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.

Time frame
immediately after the intervention.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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