Clinical trial NCT06648486: Robot-assisted Training
Official title: Robot-assisted Rehabilitation and Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Muscular Atrophy (SMA)
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beihang University
First posted: 2024-10-18
Enrollment: 7
Sex: ALL
Minimum age (years): 5
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Age range: 5-30 years old.
2. Patients with spinal muscular atrophy (SMA).
3. The subject or guardian is willing and able to sign an informed consent form.

Exclusion Criteria:

1. Simultaneously suffering from other major diseases or illnesses.
2. Special populations such as pregnant and lactating women.
3. Refusing to sign the informed consent form or being unable to complete the entire research process.
4. Currently infected with human immunodeficiency virus (HIV), infectious hepatitis B or C, or corresponding medical history.
5. Simultaneously suffering from medical problems, including but not limited to the following:

Uncontrolled hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 95mmHg), congestive heart failure (New York Heart Association status classification III or IV).

The participant is mentally incapable or unable to understand the requirements for participating in the study.

Primary outcomes:
measure: Change in cross sectional area of quadriceps
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in longitudinal cross-sectional width of quadriceps
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in peak torque
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in average torque
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in work of knee
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in Surface Electromyography (sEMG)
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in Nerve conduction
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in height
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
measure: Change in joint angle
timeFrame: Baseline, after 1.5 months, after 3 months and after 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
References: