Recovery of Walking in Persons With Complete Spinal Cord Injury

January 17, 2020 updated by: Middle Tennessee State University

Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise
Walk training
Behavioral: Exercise
Underwater treadmill training and supplemental overground walk training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overground walking capacity
Time Frame: Change from Baseline WISCI-II score at 6 months and 12 months
Walking Capacity for Spinal Cord Injury (WISCI-II)
Change from Baseline WISCI-II score at 6 months and 12 months

Collaborators and Investigators

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

Sponsor

Middle Tennessee State University

Investigators

  • Study Director: Don W Morgan, PhD, Middle Tennessee State University
  • Principal Investigator: Sandra L Stevens, PhD, PT, Middle Tennessee State University

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)

July 5, 2011

Primary Completion (Actual)

August 6, 2013

Study Completion (Actual)

August 6, 2013

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-310

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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