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Recovery of Walking in Persons With Complete Spinal Cord Injury

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Sponsored by
Middle Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Exercise, Walking, Aquatics

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Exercise

    Arm Description

    Walk training

    Outcomes

    Primary Outcome Measures

    Overground walking capacity
    Walking Capacity for Spinal Cord Injury (WISCI-II)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2020
    Last Updated
    January 17, 2020
    Sponsor
    Middle Tennessee State University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04237363
    Brief Title
    Recovery of Walking in Persons With Complete Spinal Cord Injury
    Official Title
    Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 5, 2011 (Actual)
    Primary Completion Date
    August 6, 2013 (Actual)
    Study Completion Date
    August 6, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Middle Tennessee State University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).
    Detailed Description
    Regular exposure to self-initiated treadmill walking in water, a unique sensorimotor exercise setting that makes stepping movements easier to perform, may capitalize on the adaptability of the neuromuscular system and enhance locomotor function in persons with cSCI who have not undergone eSCS. In our study, a combined aquatics- and land-based approach to gait training was employed over a 12-month period that featured underwater treadmill training and supplemental overground walk training.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Spinal Cord Injuries
    Keywords
    Spinal Cord Injury, Exercise, Walking, Aquatics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    5 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Exercise
    Arm Type
    Experimental
    Arm Description
    Walk training
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Underwater treadmill training and supplemental overground walk training
    Primary Outcome Measure Information:
    Title
    Overground walking capacity
    Description
    Walking Capacity for Spinal Cord Injury (WISCI-II)
    Time Frame
    Change from Baseline WISCI-II score at 6 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Don W Morgan, PhD
    Organizational Affiliation
    Middle Tennessee State University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Sandra L Stevens, PhD, PT
    Organizational Affiliation
    Middle Tennessee State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Recovery of Walking in Persons With Complete Spinal Cord Injury

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