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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 September 2022 |
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Main ID: |
NCT03343132 |
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Date of registration:
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09/10/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury
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Scientific title:
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Gait Adaptability: Tracking Locomotor Recovery After Incomplete Spinal Cord Injury Via Sensitive Assessments in a Virtual Reality Treadmill Environment |
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Date of first enrolment:
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January 1, 2018 |
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Target sample size:
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98 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03343132 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Switzerland
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Gait Disorders, Neurologic
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Gait Disorder, Sensorimotor
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Intervention(s)
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Behavioral: Standard locomotor therapy
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Primary Outcome(s)
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Change in kinematics
[Time Frame: Baseline and through study completion, an average of 4 months]
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Secondary ID(s)
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2017-01780
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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