Robot-assisted Training

NCT06648486 | Recruiting DMC

• 1 other identifier: 2024-973-02
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Muscular Atrophy (SMA)

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• 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

Study Arms (3)

Robot-assisted Rehabilitation for children with SMA type II

EXPERIMENTAL

Device: With the assistance of wearable isokinetic training robot （ 7 children with SMA type II）

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.

Interventions

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)

Robot-assisted Rehabilitation for children with SMA type II

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beihang University: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

RECRUITING

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Central Study Contacts

Fuzhen Yuan, Dr.

CONTACT

+8618811728786; feng_yanggang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 7 Children with SMA, 6 Healthy Children as comparison
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 18, 2024
• Study Start: February 25, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: August 29, 2025

Record last verified: 2025-08

Locations

CN (1)