Spinal Muscular Atrophy (SMA)NCT06648486
Robot-assisted Training
A study testing With the assistance of wearable isokinetic training robot （ 7 children with SMA type II） in people with Spinal Muscular Atrophy (SMA), run by Peking University Third Hospital at 1 site in China.
Trial 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?… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spinal Muscular Atrophy (SMA)
- What is being tested?
- With the assistance of wearable isokinetic training robot （ 7 children with SMA type II）
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2025to 30 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range: 6-12 years old.
- Diagnosed with Type II Spinal Muscular Atrophy (SMA).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100091
About this study
Official title: Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA
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.
- Conditions
- Spinal Muscular Atrophy (SMA)
- Being tested
- With the assistance of wearable isokinetic training robot （ 7 children with SMA type II）
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| Robot-assisted Rehabilitation for children with SMA type II | Experimental | Not described Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cross sectional area of quadriceps
Using Magnetic Resonance Imaging (MRI)
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in longitudinal cross-sectional width of quadriceps
Using Magnetic Resonance Imaging (MRI)
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in peak torque
Using isokinetic training robot to measure.
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in average torque
Using isokinetic training robot to measure.
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in work of knee
Work = Torque * Speed
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in Surface Electromyography (sEMG)
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in Nerve conduction
Nerve Conduction Velocity Testing System
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Secondary outcomes (3)
Change in weight
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in height
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Change in joint angle
Measured: Baseline, after 1.5 months, after 3 months and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start25 Feb 2025
- Primary completion30 Aug 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beihang University
- Responsible party
- Principal investigator, Yuan Fuzhen, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648486
- Sponsor's protocol ID
- 2024-973-02
- Status last verified
- May 2026
- First submitted
- 3 Oct 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Portable Isokinetic Knee Training Device for Quadriceps Rehabilitation in Children With SMA
- ClinicalTrials.gov ID
- NCT06648486
- Acronym / sponsor ID
- 2024-973-02
- Conditions
- Spinal Muscular Atrophy (SMA)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Beihang University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 18 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age range: 6-12 years old.
- Diagnosed with Type II Spinal Muscular Atrophy (SMA).
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | Robot-assisted Rehabilitation for children with SMA type II |
Primary outcome
Change in cross sectional area of quadriceps
Time frame: 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
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using Magnetic Resonance Imaging (MRI)
Change in peak torque
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in average torque
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Using isokinetic training robot to measure.
Change in work of knee
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Work = Torque * Speed
Change in Surface Electromyography (sEMG)
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Change in Nerve conduction
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Nerve Conduction Velocity Testing System
3 secondary outcomes
Change in weight
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Change in height
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Change in joint angle
Time frame: Baseline, after 1.5 months, after 3 months and after 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing With the assistance of wearable isokinetic training robot （ 7 children with SMA type II） in people with Spinal Muscular Atrophy (SMA), run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cross sectional area of quadriceps (time frame: Baseline, after 1.5 months, after 3 months and after 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.