RecruitingNot ApplicableNCT06648486

Robot-assisted Training

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


Sponsor

Peking University Third Hospital

Enrollment

13 participants

Start Date

Feb 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 6 YearsMax Age: 12 Years

Inclusion Criteria2

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

Exclusion Criteria4

  • 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.

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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)


Locations(1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

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NCT06648486


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