Exoskeleton DeviceNCT06097000
A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
A study testing powered exoskeletons in people with Exoskeleton Device, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Exoskeleton Device
- What is being tested?
- powered exoskeletons
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2023to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years old;
- Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
- The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;
Who cannot join
- Short expected survival from malignant diseases;
- Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
- Suffering from other neurological diseases;
- Planned to undergo other surgeries within 3 months;
- Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Intelligent Powered Exoskeleton
Beijing, Beijing Municipality
Wanru Duan, Associate Professor, (+86)13581803400, duanwanru@xwhosp.org
About this study
Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.
- Conditions
- Exoskeleton Device
- Being tested
- powered exoskeletons
- Keywords
- Hip Exoskeleton Device, Spinal Cord Injuries, Rehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
powered exoskeletonsDevice
Whether to use powered exoskeletons for exercise rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Powered Exoskeleton Group | Experimental | Rehabilitation exercises with powered exoskeletons Receives: Device: powered exoskeletons |
| Traditional Group | No intervention | Rehabilitation exercises without the use of powered exoskeletons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six-minute walk test
meter; distance participants walked as fast as possible in a flat corridor in six minutes
Measured: 3 months
Secondary outcomes (12)
Average rate of change in muscle strength
(change in muscle strength level* number of persons)/total number of persons enrolled in the group
Measured: 3 months
10 meter autonomous walking test
meter; participants walk ten meters at a self-selected speed
Measured: 3 months
10 meter fast walking test
meter; participants walk ten meters at fastest speed
Measured: 3 months
rate of change in hip joint mobility
(hip joint mobility with assistance - hip joint mobility without assistance)/hip joint mobility without assistance; use joint mobility scales to measure hip joint mobility
Measured: 3 months
stride length
centimeter; left and right legs are measured separately
Measured: 3 months
rate of change in heart rate
(post-training heart rate - resting heart rate)/resting heart rate
Measured: 3 months
rate of change in arterial partial pressure of oxygen
(post-training arterial partial pressure of oxygen - arterial partial pressure of oxygen at rest)/arterial partial pressure of oxygen at rest
Measured: 3 months
adverse event incidence rate
Number of cases of adverse events/number of enrollees
Measured: 12 months
serious adverse event incidence rate
Number of cases of serious adverse events/number of enrollees
Measured: 12 months
Thigh Swing Speed
degrees/second; left and right legs are measured separately
Measured: 3 months
Thigh Lifting Moment
Newton*Meter; left and right legs are measured separately
Measured: 3 months
Thigh Swing Angle
degree; left and right legs are measured separately
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start20 Oct 2023
- Primary completion20 Nov 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exoskeleton DeviceStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- BEIJING DNSYS INNOVATION Co. Ltd, Beijing Haidian Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097000
- Sponsor's protocol ID
- XW-NS-IPEPSR
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2023
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Safety and Efficacy of Intelligent Powered Exoskeletons in Postoperative Spinal Rehabilitation
- ClinicalTrials.gov ID
- NCT06097000
- Acronym / sponsor ID
- XW-NS-IPEPSR
- Conditions
- Exoskeleton Device
- Keywords
- Hip Exoskeleton Device, Spinal Cord Injuries, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- BEIJING DNSYS INNOVATION Co. Ltd, Beijing Haidian Hospital
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- 20 Nov 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 24 Oct 2023 (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.
Systematic and professional rehabilitation training is generally effective for patients with lower limb dyskinesia, but most of them lose the chance of recovery due to failure to receive systematic rehabilitation treatment. Our team has developed an intelligent power armor for patients with lower limb motor dysfunction, which can assist patients to complete high-quality rehabilitation training. In order to evaluate the safety and efficacy of the Smart Power Armor for post-surgical spine patients, and to provide data support for a confirmatory clinical study, we designed a single-center, prospective, randomized controlled study to compare the level of recovery of lower limb motor function in patients with different rehabilitation strategies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Powered Exoskeleton Group | Experimental | Device: powered exoskeletonsRehabilitation exercises with powered exoskeletons |
| Traditional Group | No intervention | –Rehabilitation exercises without the use of powered exoskeletons |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-70 years old;
- Spinal surgery within 1 year due to degeneration, tumor, trauma or other reasons, postoperative motor disorders of both lower limbs, such as muscle weakness (3-5 level reduction), increased muscle tone, gait incoordination caused by deep sensory loss, etc.;
- The patient does not have a plan to rehabilitate in a specialized rehabilitation hospital, and plans to rehabilitate at home;
Key exclusion criteria (5 listed)
- Short expected survival from malignant diseases;
- Muscle strength is less than grade 3, and the muscles of both lower limbs are severely atrophied;
- Suffering from other neurological diseases;
- Planned to undergo other surgeries within 3 months;
- Unable to cooperate with the transmission power external armor or cooperate with the rehabilitation training due to the physical condition;
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 |
|---|---|---|
| powered exoskeletonsWhether to use powered exoskeletons for exercise rehabilitation | Device | Powered Exoskeleton Group |
Primary outcome
Six-minute walk test
Time frame: 3 months
meter; distance participants walked as fast as possible in a flat corridor in six minutes
12 secondary outcomes
Average rate of change in muscle strength
Time frame: 3 months
10 meter autonomous walking test
Time frame: 3 months
10 meter fast walking test
Time frame: 3 months
rate of change in hip joint mobility
Time frame: 3 months
stride length
Time frame: 3 months
rate of change in heart rate
Time frame: 3 months
rate of change in arterial partial pressure of oxygen
Time frame: 3 months
adverse event incidence rate
Time frame: 12 months
serious adverse event incidence rate
Time frame: 12 months
Thigh Swing Speed
Time frame: 3 months
Thigh Lifting Moment
Time frame: 3 months
Thigh Swing Angle
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
Related trials for Exoskeleton Device
Recruiting
Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology.
Exoskeleton Device, Sensory Disorder
Not yet recruiting
Exploring the Effect of the Hypershell Hip Exoskeleton on Fatiguing, Everyday Activities in Older Adults
Fatigue, Older Adults (65 Years and Older)
Not yet recruitingObservational study
Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC)
Disorders of Consciousness Due to Severe Brain Injury, Disorders of Consciousness
Active, not recruitingPhase 4
Upper Limb Robot-Assisted Therapy in Patients With Guillain-Barré Syndrome
Guillain Barré Syndrome
Recruiting
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
Gait Impairment, Cerebral Palsy (CP)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing powered exoskeletons in people with Exoskeleton Device, run by Xuanwu Hospital, Beijing 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Jul 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanru Duan (13581803400, duanwanru@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six-minute walk test (time frame: 3 months). 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 11 Jul 2025.