Robot-assisted Training

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

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.

Study Overview

• Status: Completed
• Conditions: Spinal Muscular Atrophy (SMA)
• Intervention / Treatment: Device: With the assistance of wearable isokinetic training robot （ 7 children with SMA type II）

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100091
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot-assisted Rehabilitation for children with SMA type II	Device: With 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)
No Intervention: Non-robot-assisted Rehabilitation for children with SMA type II; 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.
No Intervention: Biomechanical measures for healthy children; A single set of biomechanical measurements will be taken from healthy children to serve as a reference baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beihang University

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2025
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: October 3, 2024
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; Motor Neuron Disease; Muscular Atrophy, Spinal
• Other Study ID Numbers: 2024-973-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No