HOMe-IMprove Telerrehabilitation System

NCT07091461 | Not Yet Recruiting

• 1 other identifier: HOMIMTES-CHilD
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Keywords

home; children; infantile cerebral palsy; family; upper extremity; balance

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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)

  baseline, immediately after the intervention, 1 month after intervention

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

  baseline, immediately after the intervention

• Change in occupational performance and satisfaction assessed by the Canadian Occupational Performance Measure (COPM)

  baseline, immediately after the intervention, 1 month after intervention

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

  immediately after the intervention.

Study Arms (2)

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.

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.

Other: Conventional Home Physiotherapy

Interventions

HOME Kit Tablet-based Telerehabilitation DEVICE

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

HOME Kit Tablet Telerehabilitation

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.

Conventional Home Physiotherapy

Eligibility Criteria

• Age: 6 Years - 18 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Rocío Palomo-Carrión, PT PhD

CONTACT

34926051821; Rocio.Palomo@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02