Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
13 participants
INTERVENTIONAL
2025-02-25
2025-08-30
Brief Summary
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• 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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Robot-assisted Rehabilitation for children with SMA type II
With 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)
Non-robot-assisted Rehabilitation for children with SMA type II
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.
No interventions assigned to this group
Biomechanical measures for healthy children
A single set of biomechanical measurements will be taken from healthy children to serve as a reference baseline.
No interventions assigned to this group
Interventions
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With 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)
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with Type II Spinal Muscular Atrophy (SMA).
Exclusion Criteria
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.
6 Years
12 Years
ALL
No
Sponsors
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Beihang University
OTHER
Peking University Third Hospital
OTHER
Responsible Party
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Yuan Fuzhen
Principle Investigator
Locations
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Peking University Third Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2024-973-02
Identifier Type: -
Identifier Source: org_study_id
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