Spinal Cord Injuries Clinical Trial
Official title:
Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury
| NCT number | NCT04237363 |
| Other study ID # | 11-310 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | July 5, 2011 |
| Est. completion date | August 6, 2013 |
| Verified date | January 2020 |
| Source | Middle Tennessee State University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS).
| Status | Completed |
| Enrollment | 5 |
| Est. completion date | August 6, 2013 |
| Est. primary completion date | August 6, 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 21 Years and older |
| Eligibility |
Inclusion Criteria - At least 21 years of age - Presence of traumatic or non-traumatic spinal cord injury for at least 1 year - Medical diagnosis of paraplegia (T1 or below) Exclusion Criteria - Presence of complex comorbidities that could limit involvement in training activities - Surgical implantation or removal of a medical device six months prior to training - Skin breakdown - Use of electrical implants to promote ambulation |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Middle Tennessee State University |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overground walking capacity | Walking Capacity for Spinal Cord Injury (WISCI-II) | Change from Baseline WISCI-II score at 6 months and 12 months |
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