NCT03992690

Brief 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 paraplegia due to spinal cord injury.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 2, 2019

Status Verified

June 1, 2019

Enrollment Period

8 months

First QC Date

June 18, 2019

Last Update Submit

July 30, 2019

Conditions

Chronic Paraplegia

Outcome Measures

Primary Outcomes (1)

  • 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)

    After nine-months of training

Secondary Outcomes (4)

  • The change of nociception improvement: ASIA pin-prick sensory score

    After nine-months of training

  • Improvement of Walking index for SCI (WISCI)

    After nine-months of training

  • Change of WHO-QoL bref

    After nine-months of training

  • Change of post-void residual urine

    After nine-months of training

Study Arms (2)

WANR protocol

EXPERIMENTAL

Including training with Brain-machine interfaces, visuo-tactile feedback and assisted locomotion

Device: Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol

Classical physiotherapy protocol

ACTIVE COMPARATOR

Training with classical physiotherapy protocol

Device: Training with traditional physiotherapy protocol

Interventions

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.

WANR protocol
Training with traditional physiotherapy protocolDEVICE

Stretching

Classical physiotherapy protocol

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \. Discomplete spinal cord injury;
  • \. Traumatic etiology;
  • \. American Spinal Injury Association Impairment Scale(ASIA) A grade;
  • \. The level of SCI in T9-T12;
  • \. ≥12 months post injury;
  • \. Considered independents to perform daily life activities: feeding, dressing, capability with wheelchair;
  • \. Emotional stability;

You may not qualify if:

  • \. Absence of SCI, or presence of multi-segmental injury;
  • \. SCI non-traumatic etiology;
  • \. Age\<18 years or Age\>60 years;
  • \. Emotional instability;
  • \. Unavailable time to join the protocol activities;
  • \. Already enrolled in other research protocol;
  • \. 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);
  • \. Alcohol/drugs abuse and dependence;
  • \. Psychiatric disorders (exception: treated depression);
  • Cognitive deficit; visual deficit; auditory deficit;
  • \. Incapacitating pain;
  • \. Pregnancy;
  • \. Presence of limb amputations (exception: hand distal phalanges);
  • \. Peripheral neuropathy associated (e.g.: brachial plexus injury, carpal tunnel syndrome);
  • \. Muscle injury associated (e.g. myotendinous rupture, burning injury, muscle-compartment syndrome);
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Interventions

Brain-Computer Interfaces

Intervention Hierarchy (Ancestors)

Electrical Equipment and SuppliesEquipment and Supplies

Study Officials

  • Guo-Guang Zhao, M.D.

    Xuanwu Hospital, Beijing

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peng-Hu Wei, M.D.

CONTACT

00861083198252weipenghu@xwhosp.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 20, 2019

Study Start

August 1, 2019

Primary Completion

March 31, 2020

Study Completion

December 31, 2020

Last Updated

August 2, 2019

Record last verified: 2019-06

Locations

CN(1)