Robot-assisted Training

Peking University

Status: Enrolling

Conditions: Spinal Muscular Atrophy (SMA)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06648486

2024-973-02

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 3 patient groups

Robot-assisted Rehabilitation for children with SMA type II

Experimental group

Treatment:

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 group

Description:

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 group

Description:

A single set of biomechanical measurements will be taken from healthy children to serve as a reference baseline.