Robot-Assisted Mirror Therapy in the Rehabilitation of Hemiparetic Cerebral Palsy

NCT07763691 | Active Not Recruiting

• 1 other identifier: E-10840098-202.3.02-8027 /1298
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether robot-assisted mirror therapy improves upper extremity function in children with spastic hemiparetic cerebral palsy. The study will also compare the effects of robot-assisted mirror therapy with those of conventional mirror therapy. The main questions this study aims to answer are:

• Does robot-assisted mirror therapy improve spasticity, grip strength, selective motor control, hand skills, bimanual performance, participation in activities of daily living, and quality of life?
• Does robot-assisted mirror therapy improve upper extremity function more than conventional mirror therapy? Researchers will compare robot-assisted mirror therapy combined with neurodevelopmental treatment with conventional mirror therapy combined with neurodevelopmental treatment. Participants will:
• Receive individualized neurodevelopmental treatment for 6 weeks.
• Complete a 2-week interval after neurodevelopmental treatment.
• Be randomly assigned to either the robot-assisted mirror therapy group or the conventional mirror therapy group.
• Receive robot-assisted mirror therapy or conventional mirror therapy twice a week for 6 weeks.
• Complete assessments before neurodevelopmental treatment, after neurodevelopmental treatment, before the study intervention, and after the intervention. Researchers will evaluate upper extremity function, spasticity, grip strength, selective motor control, hand skills, bimanual performance, participation in activities of daily living, and quality of life using standardized clinical assessment tools.

Conditions

Cerebral Palsy (CP); Hemiparetic Cerebral Palsy

Keywords

Hemiplegic Cerebral Palsy; Cerebral Palsy; Mirror Therapy; Robotic-Assisted Mirror Therapy; Rehabilitation; Visual Feedback; Wearable Robotics; Spastic Hemiparesis

Outcome Measures

Primary Outcomes (2)

• Change in Self-Perceived Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure (COPM) is a client-centered measure of occupational performance in self-care, productivity, and leisure. Children identify important activities they want, need, or are expected to perform but find difficult and rate their performance on a 10-point scale; higher scores indicate better performance. The mean performance score is the sum of the ratings divided by the number of activities. Changes in the mean performance score will be calculated for the relevant assessment periods by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate improved self-perceived occupational performance. In the present study, the COPM will be used to assess children's occupational performance in daily life activities they identify as important.

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

• Change in Self-Perceived Satisfaction With Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)

  The Canadian Occupational Performance Measure (COPM) is a client-centered measure of satisfaction with occupational performance in self-care, productivity, and leisure. Children identify important activities they want, need, or are expected to perform but find difficult and rate their satisfaction with their performance on a 10-point scale; higher scores indicate greater satisfaction. The mean satisfaction score is the sum of the ratings divided by the number of activities. Changes in the mean satisfaction score will be calculated for the relevant assessment periods by subtracting the baseline score from the Week 6 score and the Week 8 score from the Week 14 score. Positive change scores indicate increased satisfaction with occupational performance. In the present study, the COPM will be used to assess children's satisfaction with their performance in daily life activities they identify as important.

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

Secondary Outcomes (13)

• Change in Wrist Flexor Spasticity as Assessed by the Modified Ashworth Scale (MAS)

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

• Change in Wrist Extensor Spasticity as Assessed by the Modified Ashworth Scale (MAS)

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

• Change in Forearm Pronator Spasticity as Assessed by the Modified Ashworth Scale (MAS)

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

• Change in Forearm Supinator Spasticity as Assessed by the Modified Ashworth Scale (MAS)

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

• Change in Selective Motor Control of the Affected Upper Extremity as Measured by the Total Selective Control of the Upper Extremity Scale (SCUES) Score

  Baseline; end of Week 6 (after the NDT period); end of Week 8 (immediately before the combined intervention: NDT+RAT or NDT+MT); and end of Week 14 (immediately after the 6-week combined intervention: NDT+RAT or NDT+MT)

Study Arms (2)

Robot-Assisted Mirror Therapy (RAT)

EXPERIMENTAL

All participants will first undergo baseline assessment and receive neurodevelopmental treatment (NDT). After the NDT period, participants will be reassessed and randomized. Participants allocated to this arm will receive robot-assisted mirror therapy in addition to NDT twice weekly for 6 weeks. Each session will include 40 minutes of NDT and 30 minutes of robotic intervention. Participants will perform the planned exercises with the unaffected upper extremity positioned in front of the therapy mirror (Metafiz, Turkey), while the hemiparetic upper extremity will be positioned behind the mirror inside a robotic glove (FosilTech, Turkey). The commercially available robotic glove uses a mechanism similar to that of devices previously shown feasible for pediatric rehabilitation. During the intervention, it will provide passive symmetrical movements to the affected upper extremity corresponding to the exercises performed by the unaffected upper extremity in front of the mirror.

Device: Robot-Assisted Mirror Therapy; Behavioral: Neurodevelopmental Treatment

Mirror Therapy (MT)

ACTIVE COMPARATOR

All participants will undergo baseline assessment and receive neurodevelopmental treatment (NDT). After completion of the NDT period, participants will be reassessed and randomized. Participants assigned to this arm will receive a combined intervention consisting of NDT and conventional mirror therapy twice weekly for 6 weeks. Each session will include 40 minutes of NDT followed by 30 minutes of mirror therapy. During mirror therapy, participants will perform the planned exercises with the unaffected upper extremity positioned in front of the therapy mirror (Metafiz, Turkey), while the affected upper extremity will be positioned behind the mirror. No intervention will be applied directly to the affected upper extremity during mirror therapy. Participants will observe the mirror reflection of the unaffected upper-extremity movements, thereby creating the visual illusion that the affected upper extremity is performing the movements.

Behavioral: Mirror Therapy; Behavioral: Neurodevelopmental Treatment

Interventions

Robot-Assisted Mirror Therapy DEVICE

Participants will receive robot-assisted mirror therapy in addition to neurodevelopmental treatment. The unaffected hand will perform movements in front of a mirror, while the affected hand will be positioned behind it inside a pneumatic robotic glove (FosilTech, Turkey). The glove operates through air compression and vacuum. For each movement, the air valves controlling the fingers will be set open or closed. Open valves permit airflow and passive finger movement, whereas closed valves restrict airflow and stop selected fingers. The valve configuration will be adjusted to create a hand position symmetrical to that of the unaffected hand. The motor will be operated via remote control in synchrony and coordination with the unaffected-hand movements, producing corresponding passive movements of the affected hand and providing mirrored visual feedback and bilateral movement training. Robot-assisted mirror therapy will be administered for 30 minutes per session, twice weekly for 6 weeks.

Robot-Assisted Mirror Therapy (RAT)

Mirror Therapy BEHAVIORAL

Participants will receive conventional mirror therapy in addition to neurodevelopmental treatment. A mirror is positioned in the participant's midsagittal plane to create the visual illusion that the affected upper extremity is moving normally while performing bilateral upper extremity exercises. Mirror therapy will be administered for 30 minutes per session, twice weekly for 6 weeks.

Mirror Therapy (MT)

Neurodevelopmental Treatment BEHAVIORAL

Participants will receive a neurodevelopmental treatment (NDT) program administered by a physiotherapist. The intervention will focus on facilitating normal movement patterns, postural control, balance, and upper extremity function through task-oriented therapeutic activities. NDT will be administered for 40 minutes per session, twice weekly for 6 weeks.

Mirror Therapy (MT); Robot-Assisted Mirror Therapy (RAT)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children classified within levels I, II, or III of the Communication Function Classification System (CFCS) Medical records indicating a diagnosis of prenatal, intrapartum, or very early postnatal hemiparetic cerebral palsy, confirmed by neurologists and supported by magnetic resonance imaging (MRI).
• Being between 6-17 years of age Being able to cooperate Attending age-appropriate classes Ability to extend the wrist by more than 20 degrees and the metacarpophalangeal joints by more than 10 degrees Ability to voluntarily release objects with the affected hand

You may not qualify if:

• Diagnosis of intellectual disability and/or low cognitive level suitable for attending a special education school, Behavioral and adaptation difficulties observed in the child during the administration of study assessments.
• Diagnosis of attention deficit and/or hyperactivity disorder History of epileptic seizures Upper extremity fracture, muscle-tendon or bone surgery within the past six months, or use of any pharmacological agents to inhibit spasticity, including botulinum toxin administration Uncorrected hearing and/or visual impairment Severe muscle tone in the shoulder, elbow, or wrist, indicated by a Modified Ashworth Scale score greater than 3.
• Any new treatment planned during the study period

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Dilbade Özel Eğitim ve Rehabilitasyon Merkezi

Istanbul, 34050, Turkey (Türkiye)

Location

Related Publications (25)

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MeSH Terms

Conditions

Cerebral Palsy; Hemiplegia

Interventions

Mirror Movement Therapy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist, PhD Candidate

Model Details: All participants initially receive neurodevelopmental treatment and are evaluated before and after this initial treatment period. Following this period, participants are randomized into two parallel groups. One group receives robot-assisted therapy in addition to neurodevelopmental treatment, while the other group receives mirror therapy in addition to neurodevelopmental treatment. This design allows the effects of the initial neurodevelopmental treatment period to be evaluated, as well as the effects of the two subsequent treatment approaches to be compared.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 13, 2026
• Study Start: March 25, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning upon publication of the primary study results in an international peer-reviewed journal and continuing for 5 years.
• Access Criteria: Following publication of the primary study results in an international peer-reviewed journal, de-identified individual participant data, the study protocol, data dictionary, statistical analysis plan and informed consent form will be available to qualified researchers who submit a methodologically sound research proposal. Data will be shared upon reasonable request to the principal investigator and may require a data use agreement.

Locations

TU (1)