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| Name | Class |
|---|---|
| Beihang University | OTHER |
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The goal of this clinical trial is to evaluate the long-term effects of isokinetic rehabilitation training in patients with spinal muscular atrophy (SMA). The main question it aims to answer is:
• Does isokinetic training at fixed angular velocity improve muscle strength and functional recovery in SMA patients?
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robot-assisted Rehabilitation for children with SMA type II | Experimental |
| |
| Non-robot-assisted Rehabilitation for children with SMA type II | No Intervention | Prior to the intervention, all participants will complete a 1.5-month "Stage 0" observation period with no robot assistance. During this time, we will record each child's sit-to-stand angle to establish baseline (control) measurements. | |
| Biomechanical measures for healthy children | No Intervention | A single set of biomechanical measurements will be taken from healthy children to serve as a reference baseline. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| With the assistance of wearable isokinetic training robot ( 7 children with SMA type II) | Device | A child with SMA will use a wearable isokinetic training robot to train the knee joint for three stages. ( Stage 1: 1.5 months=30 sessions; Stage 2 (follow up): 1.5 months=18 sessions, Stage 3(follow up) = 0 session) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cross sectional area of quadriceps | Using Magnetic Resonance Imaging (MRI) | Baseline, after 1.5 months, after 3 months and after 4 months |
| Change in longitudinal cross-sectional width of quadriceps | Using Magnetic Resonance Imaging (MRI) | Baseline, after 1.5 months, after 3 months and after 4 months |
| Change in peak torque | Using isokinetic training robot to measure. | Baseline, after 1.5 months, after 3 months and after 4 months |
| Change in average torque | Using isokinetic training robot to measure. | Baseline, after 1.5 months, after 3 months and after 4 months |
| Change in work of knee | Work = Torque * Speed | Baseline, after 1.5 months, after 3 months and after 4 months |
| Change in Surface Electromyography (sEMG) | Baseline, after 1.5 months, after 3 months and after 4 months | |
| Change in Nerve conduction | Nerve Conduction Velocity Testing System | Baseline, after 1.5 months, after 3 months and after 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in weight | Baseline, after 1.5 months, after 3 months and after 4 months | |
| Change in height | Baseline, after 1.5 months, after 3 months and after 4 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | Beijing Municipality | 100091 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 13, 2024 | Aug 21, 2025 | Prot_SAP_ICF_002.pdf |
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| ID | Term |
|---|---|
| D009134 | Muscular Atrophy, Spinal |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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7 Children with SMA, 6 Healthy Children as comparison
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| Change in joint angle |
| Baseline, after 1.5 months, after 3 months and after 4 months |
| D019636 | Neurodegenerative Diseases |
| D009468 | Neuromuscular Diseases |