Effects of Robot-Assisted Mirror Therapy on Upper Extremity Function in the Rehabilitation of Hemiparetic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Self-Perceived Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)
研究概览
简要总结
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.
详细描述
EFFECT OF ROBOT-ASSISTED MIRROR THERAPY ON UPPER EXTREMITY FUNCTIONS IN HEMIPARETIC CEREBRAL PALSY REHABILITATION
-1 . INTRODUCTION :
Cerebral palsy (CP) is a group of permanent disorders of movement and posture caused by non-progressive disturbances in the developing brain. It has a worldwide prevalence of 2 to 3 per 1,000 live births and is the most common cause of motor disability in children. Spastic CP accounts for 85 to 91 percent of all cases, and hemiplegia is its most common subtype, accounting for approximately 38 percent of cases.
Hemiplegic cerebral palsy is characterized by unilateral motor and sensory impairments resulting from damage to the motor cortex and corticospinal tract. In nearly half of the cases, the upper limbs-particularly the hands-are more severely affected than the lower limbs. Patients typically present with limited upper extremity range of motion, increased muscle tone, muscle weakness, impaired isolated finger movements, and reduced grip function. Collectively, these symptoms adversely affect the performance of activities of daily living and participation in social life, potentially leading to the learned non-use of the affected limb and further impairment of motor function.
Various rehabilitation techniques have been developed to improve upper extremity function and performance in activities of daily living. Mirror therapy (MT), developed by Ramachandran, is one such approach. MT is based on the mirror neuron system, in which neurons in the premotor cortex and inferior parietal cortex are activated during both the observation and the execution of a movement. This technique involves placing a mirror between the unaffected and affected limbs. The mirror creates a visual illusion in which the movement of the unaffected limb is perceived as that of the affected limb. This illusion activates the mirror neuron system, which plays a key role in both action observation and action execution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria
- •Children classified within levels I, II, or III of the Gross Motor Function Classification System (GMFCS)
- •Children classified within levels I, II, or III of the Manual Ability Classification System (MACS).
- •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
排除标准
- •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
- •Any new treatment planned during the study period
研究组 & 干预措施
Robot-Assisted Mirror Therapy (RAT)
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.
干预措施: Neurodevelopmental Treatment (Behavioral)
Robot-Assisted Mirror Therapy (RAT)
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.
干预措施: Robot-Assisted Mirror Therapy (Device)
Mirror Therapy (MT)
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.
干预措施: Mirror Therapy (Behavioral)
Mirror Therapy (MT)
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.
干预措施: Neurodevelopmental Treatment (Behavioral)
结局指标
主要结局
Change in Self-Perceived Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)
时间窗: 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)
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.
Change in Self-Perceived Satisfaction With Occupational Performance as Measured by the Canadian Occupational Performance Measure (COPM)
时间窗: 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)
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.
次要结局
- 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))
- Change in Affected-Hand Function as Measured by Total Completion Time on the Jebsen-Taylor Hand Function Test (JTHFT)(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 Affected-Hand Grasp Efficacy During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Grasp Efficacy 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))
- Change in Time Utilization During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Time Utilization 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))
- Change in Perceived Bother During Bimanual Daily Activities as Measured by the Children's Hand-use Experience Questionnaire (CHEQ) Feeling Bothered 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))
- Change in Frequency of Affected Upper-Extremity Use During Daily Activities as Measured by the Mean How Often Score on the Revised Pediatric Motor Activity Log (PMAL-R)(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 Quality of Affected Upper-Extremity Use During Daily Activities as Measured by the Mean How Well Score on the Revised Pediatric Motor Activity Log (PMAL-R)(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 Parent-Reported Functional Health and Health-Related Quality of Life as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) Global Functioning 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))
- Change in Child Self-Reported Functional Health and Health-Related Quality of Life as Measured by the Pediatric Outcomes Data Collection Instrument (PODCI) Global Functioning 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))
- 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))
研究者
Özlem Aydın
Physiotherapist, PhD Candidate
Medipol University