NCT04237363

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2013

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 23, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

January 15, 2020

Last Update Submit

January 17, 2020

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord InjuryExerciseWalkingAquatics

Outcome Measures

Primary Outcomes (1)

  • Overground walking capacity

    Walking Capacity for Spinal Cord Injury (WISCI-II)

    Change from Baseline WISCI-II score at 6 months and 12 months

Study Arms (1)

Exercise

EXPERIMENTAL

Walk training

Behavioral: Exercise

Interventions

ExerciseBEHAVIORAL

Underwater treadmill training and supplemental overground walk training

Exercise

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Spinal Cord InjuriesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Don W Morgan, PhD

    Middle Tennessee State University

    STUDY DIRECTOR

  • Sandra L Stevens, PhD, PT

    Middle Tennessee State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 23, 2020

Study Start

July 5, 2011

Primary Completion

August 6, 2013

Study Completion

August 6, 2013

Last Updated

January 23, 2020

Record last verified: 2020-01