Spinal Muscular Atrophy (SMA)
Conditions
Brief summary
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: * Perform isokinetic training using a portable device with a fixed angular velocity. * Undergo long-term rehabilitation sessions, with assessments of muscle strength and overall functional improvement over the training period.
Interventions
DEVICEWith the assistance of wearable isokinetic training robot （ 7 children with SMA type II）
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)
Sponsors
Peking University Third Hospital
Beihang University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
7 Children with SMA, 6 Healthy Children as comparison
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Age range: 6-12 years old. 2. Diagnosed with Type II Spinal Muscular Atrophy (SMA).
Exclusion criteria
1. Participants with severe comorbidities, implanted medical devices preventing MRI or claustrophobia were excluded from the study. 2. Refusal to provide informed consent or inability to complete the entire study protocol, among other factors; 3. Uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥95 mmHg) or congestive heart failure classified as New York Heart Association (NYHA) Class III or IV; 4. Cognitively impaired or unable to comprehend the requirements of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cross sectional area of quadriceps | Baseline, after 1.5 months, after 3 months and after 4 months | Using Magnetic Resonance Imaging (MRI) |
| Change in longitudinal cross-sectional width of quadriceps | Baseline, after 1.5 months, after 3 months and after 4 months | Using Magnetic Resonance Imaging (MRI) |
| Change in peak torque | Baseline, after 1.5 months, after 3 months and after 4 months | Using isokinetic training robot to measure. |
| Change in average torque | Baseline, after 1.5 months, after 3 months and after 4 months | Using isokinetic training robot to measure. |
| Change in work of knee | Baseline, after 1.5 months, after 3 months and after 4 months | Work = Torque \* Speed |
| Change in Surface Electromyography (sEMG) | Baseline, after 1.5 months, after 3 months and after 4 months | — |
| Change in Nerve conduction | Baseline, after 1.5 months, after 3 months and after 4 months | Nerve Conduction Velocity Testing System |
Secondary
| Measure | 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 |
| Change in joint angle | Baseline, after 1.5 months, after 3 months and after 4 months |
Countries
China
Outcome results
None listed