Robot-assisted Training

NCT06648486 — Not applicable, Completed, 13 participants, Peking University Third Hospital

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

Registry	NCT06648486
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, single group, masking: none, treatment
Enrollment	13 (Actual)
Sponsor	Peking University Third Hospital (Other); collaborators: Beihang University
Conditions	Spinal Muscular Atrophy (SMA)
Interventions	With the assistance of wearable isokinetic training robot （ 7 children with SMA type II） (Device)
Dates	start 2025-02-25, primary completion 2025-08-30, completion 2025-08-30, first posted 2024-10-18, last updated 2026-05-22
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

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)

+Outcome measures

Primary outcomes

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 outcomes

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]

+Eligibility

Sex: All, ages: 6 Years to 12 Years

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.

+Locations (1)

Facility	City	Country	Status
Peking University Third Hospital	Beijing, Beijing Municipality	China

+Study documents

Study Protocol, Statistical Analysis Plan, and Informed Consent Form (PDF, 2024-12-13)