Chronic ParaplegiaNCT03992690
Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
A study testing Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol and Training with traditional physiotherapy protocol in people with Chronic Paraplegia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Paraplegia
- What is being tested?
- Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol and Training with traditional physiotherapy protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2020
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Discomplete spinal cord injury;
- 2. Traumatic etiology;
- 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
- 4. The level of SCI in T9-T12;
- 5. ≥12 months post injury;
- 6. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
- 7. Emotional stability;
Who cannot join
- 1. Absence of SCI, or presence of multi-segmental injury;
- 2. SCI non-traumatic etiology;
- 3. Age<18 years or Age>60 years;
- 4. Emotional instability;
- 5. Unavailable time to join the protocol activities;
- 6. Already enrolled in other research protocol;
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- 7. Acute or chronic decompensated comorbidities (e.g. Hypertension, Diabetes, cardiomyopathy, chronic respiratory insufficiency, chronic renal insufficiency, hepatopathy, or any other neurological disorders besides the SCI);
- 8. Alcohol/drugs abuse and dependence;
- 9. Psychiatric disorders (exception: treated depression);
- 10.Cognitive deficit; visual deficit; auditory deficit;
- 11. Incapacitating pain;
- 12. Pregnancy;
- 13. Presence of limb amputations (exception: hand distal phalanges);
- 14. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
- 15. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
- 16. Neuromuscular disease associated (ex: myopathy) or lower limb fractures within the past six months;
- 17. Movement disorders(e.g. ataxia);
- 18. Use of medication that can negatively impact on neurological/motor recovery;
- 19. Presence of joint deformities, presence of fractures;
- 20. Lower limb spasticity MAS (Modified Ashworth Scale)>2;
- 21. Pressure ulcer: considering grade 3 or 4, injury size and body location;
- 22. Cephalic metallic /magnetic implants (exception: MRI compatible implants);
- 23. Presence of cardiac or neural pacemaker;
- 24. Use of devices/tubes: tracheostomy, gastrostomy, nasogastric, long-term bladder catheterization, cystostomy, colostomy, totally implanted catheter system, arteriovenous dialysis fistula;
- 25. Severe osteoporosis (Tscore>-4);
- 26. Syringomyelia;
- 27. Lokomat or ZeroG training within the prior 3 months.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
Peng-Hu Wei, M.D., 010-83198899 ext. 010-83198836, weipenghu@xwhosp.org
About this study
The purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.
- Conditions
- Chronic Paraplegia
- Being tested
- Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol, Training with traditional physiotherapy protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocolDevice
Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
Training with traditional physiotherapy protocolDevice
Stretching
| Study group | Role | What they receive |
|---|---|---|
| WANR protocol | Experimental | Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion Receives: Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol |
| Classical physiotherapy protocol | Active comparator | Training with classical physiotherapy protocol Receives: Device: Training with traditional physiotherapy protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side)
Measured: After nine-months of training
Secondary outcomes (4)
The change of nociception improvement: ASIA pin-prick sensory score
Testing of a key point in each of the 28 dermatomes (from C2 to S4-5) on the right and left sides of the body that can be readily located in relation to bony anatomical landmarks. At each of these key points, sensation of pin prick is examined:
Appreciation of pin prick sensation at each of the key points is separately scored on a three-point scale, with comparison to the sensation on the patients' cheek as a normal frame of reference:
0 = absent
1= altered (impaired or partial appreciation, including hyperesthesia)
2 = normal or intact (similar as on the cheek)
NT = not testable
The maximum scale is 112
Measured: After nine-months of training
Improvement of Walking index for SCI (WISCI)
The subject is observed by the trained personnel and the WISCI level is recorded on the scale of 0 to 20 at baseline (Baseline WISCI). The subject is observed again at the defined interval (Interval WISCI). The change in score is calculated by subtracting the baseline WISCI from the Interval WISCI, which equals the change in WISCI (Changed WISCI).
Measured: After nine-months of training
Change of WHO-QoL bref
The WHOQOL-BREF questionnaire contains two items from the Overall QOL and General Health and 24 items of satisfaction that divided into four domains. Raw domain scores for the WHOQOL were transformed to a 4-20 score according to guidelines
Measured: After nine-months of training
Change of post-void residual urine
Usually, the value is less than 50 ml. A post-void residual urine greater than 50 ml is a significant amount of urine and increases the potential for recurring urinary tract infections. In adults older than 60 years, 50-100 ml of residual urine may remain after each voiding because of the decreased contractility of the detrusor muscle
Measured: After nine-months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic ParaplegiaStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- the Alberto Santos Dumont Association for Research Support
- Responsible party
- Sponsor
- Investigators
- Guo-Guang Zhao, M.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992690
- Sponsor's protocol ID
- XW-[2019]-023
- Status last verified
- Jun 2019
- First submitted
- 18 Jun 2019
- Last updated
- 2 Aug 2019
- 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 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training With Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion for Patients With Chronic Complete Paraplegia
- ClinicalTrials.gov ID
- NCT03992690
- Acronym / sponsor ID
- XW-[2019]-023
- Conditions
- Chronic Paraplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- the Alberto Santos Dumont Association for Research Support
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 20 Jun 2019 (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 purpose of this research is to compare the effectiveness of a training protocol integrating Brain-machine Interfaces, Visuo-tactile feedback and Assisted Locomotion (referred to as the Walk Again Neurorehabilitation protocol, or WANR), with classical physiotherapy training for patients with chronic complete paraplegia due to spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WANR protocol | Experimental | Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocolIncluding training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion |
| Classical physiotherapy protocol | Active comparator | Device: Training with traditional physiotherapy protocolTraining with classical physiotherapy protocol |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Discomplete spinal cord injury;
- 2. Traumatic etiology;
- 3. American Spinal Injury Association Impairment Scale(ASIA) A grade;
- 4. The level of SCI in T9-T12;
- 5. ≥12 months post injury;
Key exclusion criteria (27 listed)
- 1. Absence of SCI, or presence of multi-segmental injury;
- 2. SCI non-traumatic etiology;
- 3. Age<18 years or Age>60 years;
- 4. Emotional instability;
- 5. Unavailable time to join the protocol activities;
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 |
|---|---|---|
| Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocolTraining integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients. | Device | WANR protocol |
| Training with traditional physiotherapy protocolStretching | Device | Classical physiotherapy protocol |
Primary outcome
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point
Time frame: After nine-months of training
The LEMS evaluates motor function on a scale of 0 (no motor function) to 5 (full motor function) for 5 lower extremity muscle groups with a 50-point maximum (25 per side)
4 secondary outcomes
The change of nociception improvement: ASIA pin-prick sensory score
Time frame: After nine-months of training
Improvement of Walking index for SCI (WISCI)
Time frame: After nine-months of training
Change of WHO-QoL bref
Time frame: After nine-months of training
Change of post-void residual urine
Time frame: After nine-months of training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- 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.
Guo-Guang Zhao, M.D. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol and Training with traditional physiotherapy protocol in people with Chronic Paraplegia, 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 7 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 2 Aug 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng-Hu Wei, M.D. (00861083198252, weipenghu@xwhosp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of Lower limbs Motor function: ASIA motor score (LEMS) at the ending time point (time frame: After nine-months of training). 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 2 Aug 2019.