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Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03343132
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : August 4, 2021
Sponsor:
Collaborator:
Foundation Wings For Life
Information provided by (Responsible Party):
University of Zurich

Study Description
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Brief Summary:
Adaptive gait assessements will be evaluated as a potential new marker for tracking locomotor recovery throughout rehabilitation of spinal cord injury subjects. To this end, controls, subacute and chronic patients will be assessed at two timepoints with 3 month standard rehabilitation inbetween. The specific assessments will require the participant to acitvely modulate their gait pattern to fullfill specific task constraints. Their performance will be assessed via 3D kinematics, kinetics and EMG and these measures will be used to describe the adaptive capacity that the patient retains. Sensitivity and specificity of these markers will be determined. With more sensitive descriptors of gait function and quality, locomotor rehabilitation for SCI can be better designed and smaller effects can be accurately measured.

Condition or disease Intervention/treatment
Gait Disorders, Neurologic Gait Disorder, Sensorimotor Behavioral: Standard locomotor therapy

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Subacute SCI Behavioral: Standard locomotor therapy
Typical clinical therapy.
Chronic SCI
Controls


Outcome Measures
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Primary Outcome Measures :
  1. Change in kinematics [ Time Frame: Baseline and through study completion, an average of 4 months ]
    Recording of movement tasks


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic; community sample
Criteria

Inclusion Criteria:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Healthy controls
  • Patients with an incomplete spinal cord injury in a chronic (at least 12 months post-injury) or subacute (3-6 months post-injury) stage of recovery
  • Age: 18 years and older
  • Able to stand without physical assistance and handrails for more than 120s
  • preserved segmental and cutaneo-muscular reflexes in the lower limbs
  • Bodyweight over 20 kg and under 120 kg
  • Mini-Mental state examination score 26 (test only performed if cognitive deficits are suspected)

Exclusion Criteria:

  • Current orthopedic problems
  • Neurological impairment other than SCI
  • Premorbid major depression or psychosis
  • Metal implants in the cervical skull
  • History of significant autonomic dysreflexia with treatment
  • Dermatological issues (e.g. decubitus) at the harness attachment site (back, abdomen, upper legs)
  • Malignant diseases
  • Heart insufficiency NYHA III-IV
  • Potential pregnancy
  • Unlikely to complete the intervention or return for follow-up
  • Participation in another training study
  • Contraindications for training using the GRAIL (according the manual)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343132


Contacts
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Contact: Armin Curt, Prof. +41 44 386 39 01 armin.curt@balgrist.ch

Locations
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Switzerland
Universitätsklinik Balgrist Recruiting
Zürich, Switzerland, 8008
Contact: Freschta Mohammadzada    +41 44 510 72 21    freschta.mohammadzada@balgrist.ch   
Contact: Charlotte Werner       charlotte.werner@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Foundation Wings For Life
More Information
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03343132    
Other Study ID Numbers: 2017-01780
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: August 4, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Nervous System Diseases
Gait Disorders, Neurologic
Disease
Pathologic Processes
 Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Neurologic Manifestations