- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03343132
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
Status
Completed
Intervention / Treatment
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
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Zürich, Switzerland, 8008
- Universitätsklinik Balgrist
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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
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Chronic SCI
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Subacute SCI
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Typical clinical therapy.
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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
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Recording of movement tasks
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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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-01780
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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