Cerebral palsy
Conditions
Interventions
Trial Group 1 (Upper Extremity Motor Dysfunction - Trial Group):1. Training of the upper limb rehabilitation robot (30 minutes/time), including the time to put on and take off the robot, rest time, an
Control group 1 (upper extremity motor dysfunction - control group):1. Artificial conventional rehabilitation therapy (30 minutes/time): focus on functional training of the proximal joints of the uppe
Trial Group 2 (Lower Extremity Motor Dysfunction - Trial Group):1. Robot gait training (30 minutes/time): adaptive children's gait adjustment, real-time step monitoring, including equipment donning an
Control group 2 (lower extremity motor dysfunction - control group):1. Artificial gait training (30 minutes/time): 1-on-1 guidance from the therapist, and the number of steps is monitored by the pedom
Experimental Group 3 (Rehabilitation Platform Group):The information platform for the management of brain dysfu
Sponsors
Xinhua Hospital Affiliated to Shanghai Jiaotong University, School of Medicine
Eligibility
Sex/Gender
All
Age
4 Years to 16 Years
Inclusion criteria
Inclusion criteria: Trial 1: 1. Children with a confirmed diagnosis of cerebral palsy. 2. Aged 4–16 years. 3. GMFCS levels I–IV; divided into two groups based on the primary site of functional impairment. (1) Upper limb functional impairment group: The primary functional impairment is characterized by difficulties in upper limb motor control (e.g., grasping, manipulation, reaching). The Manual Ability Classification System (MACS) level is II–IV, and the Gross Motor Function Classification System (GMFCS) level is = III (to ensure the ability to participate in upper limb training and assessment that requires certain sitting/standing capabilities). (2) Lower limb functional impairment group: The primary functional impairment is characterized by lower limb motor control difficulties that affect mobility (e.g., sitting, standing, walking). The GMFCS level is I–III, and the MACS level is = II (to ensure sufficient upper limb function to cooperate with lower limb training and assessment). 4. Capable of following instructions and completing tests. 5. Able to tolerate at least 30 minutes of rehabilitation training. 6. Able to reliably signal pain, fear, and discomfort using verbal or non - verbal means. 7. Understanding and signing the informed consent form. Trial 2: 1. Children with a confirmed diagnosis of cerebral palsy. 2. Aged 4–16 years. 3. GMFCS levels I–IV. 4. Capable of following instructions and completing tests. 5. Able to tolerate at least 30 minutes of rehabilitation training. 6. Able to reliably signal pain, fear, and discomfort using verbal or non-verbal means. 7. Understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: Trial 1 Upper-Limb Dysfunction Group 1. Epilepsy that is not fully controlled by medication. 2. Upper-limb surgery or onabotulinumtoxinA (type A) injections within 4 months prior to enrollment or planned within the next 2 months. 3. Severe visual, auditory, intellectual impairments, or behavioral abnormalities that interfere with upper-limb operation or comprehension of test procedures. 4. Coagulation disorders. 5. Severe obesity and/or Modified Ashworth Scale (MAS) > 4. 6. Osteoporosis or fractures. 7. Non-cooperative participants. Lower-Limb Dysfunction Group 1. Epilepsy that is not fully controlled by medication. 2. Lower-limb surgery or onabotulinumtoxinA (type A) injections within 4 months prior to enrollment or planned within the next 2 months. 3. Severe obesity and/or Modified Ashworth Scale (MAS) > 4. 4. Severe visual, auditory, intellectual impairments, or behavioral abnormalities that interfere with ambulation or comprehension of test procedures. 5. Osteoporosis or fractures. 6. Fixed knee flexion contracture > 10°. 7. Genu valgum (knee valgus) > 40°. 8. Hip subluxation with femoral head lateral displacement > 40 %. 9. Orthopedic surgery involving soft-tissue release within 9 months prior to enrollment. 10. Concurrent robotic-assisted gait training, weight-bearing restrictions, or non-cooperative participants. Trial 2 1. Epilepsy that is not fully controlled by medication. 2. Upper-limb surgery or onabotulinumtoxinA (type A) injections within 4 months prior to enrollment or planned within the next 2 months. 3. Severe visual, auditory, intellectual impairments, or behavioral abnormalities that interfere with upper-limb operation or comprehension of test procedures. 4. Coagulation disorders. 5. Severe obesity and/or Modified Ashworth Scale (MAS) > 4. 6. Osteoporosis or fractures. 7. Non-cooperative participants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Manual Ability Classification System (MACS);Gross Motor Function Measure-88 /Gross Motor Function Measure-66; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pediatric Evaluation of Disability Inventory (PEDI);Cerebral Palsy Quality of Life Questionnaire (CPQOL);Pediatric Quality of Life Inventory Cerebral Palsy Module (PedsQL-CP);Safety;Berg Balance Scale (BBS);Fugl-Meyer Assessment Upper Extremity (FMA-UE);Melbourne Assessment of Unilateral Upper Limb Function (MAUUL); | — |
Countries
China
Contacts
Public ContactXin Li
Xinhua Hospital Affiliated to Shanghai Jiaotong University, School of Medicine
Outcome results
None listed