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OpenTrials
Completed

NCT Number: NCT04237363

Recovery of Walking in Persons 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).

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Key information

Conditions

Spinal Cord Injuries Behavior Central Nervous System Diseases Motor Activity Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Underwater treadmill training and supplemental overground walk training

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Middle Tennessee State University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 23, 2020
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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