Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury

September 4, 2022 updated by: University of Zurich

Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment

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.

Study Overview

Study Type

Observational

Enrollment (Actual)

98

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zürich, Switzerland, 8008
        • Universitätsklinik Balgrist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic; community sample

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Controls
Chronic SCI
Subacute SCI
Typical clinical therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in kinematics
Time Frame: Baseline and through study completion, an average of 4 months
Recording of movement tasks
Baseline and through study completion, an average of 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

September 2, 2022

Study Completion (Actual)

September 2, 2022

Study Registration Dates

First Submitted

October 9, 2017

First Submitted That Met QC Criteria

November 10, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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