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Completed

NCT Number: NCT06648486

Robot-assisted Training

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.

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Key information

Conditions

Spinal Muscular Atrophy (SMA) Central Nervous System Diseases Motor Neuron Disease Muscular Atrophy, Spinal Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Spinal Cord Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age range: 6-12 years old.
  • Diagnosed with Type II Spinal Muscular Atrophy (SMA).

Exclusion criteria

  • Participants with severe comorbidities, implanted medical devices preventing MRI or claustrophobia were excluded from the study.
  • Refusal to provide informed consent or inability to complete the entire study protocol, among other factors;
  • 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;
  • Cognitively impaired or unable to comprehend the requirements of study participation.

Treatment and study plan

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)

Primary outcomes

  1. Change in cross sectional area of quadriceps

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Using Magnetic Resonance Imaging (MRI)

  2. Change in longitudinal cross-sectional width of quadriceps

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Using Magnetic Resonance Imaging (MRI)

  3. Change in peak torque

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Using isokinetic training robot to measure.

  4. Change in average torque

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Using isokinetic training robot to measure.

  5. Change in work of knee

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Work = Torque * Speed

  6. Change in Surface Electromyography (sEMG)

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

  7. Change in Nerve conduction

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

    Nerve Conduction Velocity Testing System

Secondary outcomes

  1. Change in weight

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

  2. Change in height

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

  3. Change in joint angle

    Time frame: Baseline, after 1.5 months, after 3 months and after 4 months

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

  • Beihang University

Registry information

Official study title

Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 18, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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