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Trial record 22 of 3260 for:    Louisville

Recovery of Bladder and Sexual Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03036527
Recruitment Status : Recruiting
First Posted : January 30, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):

January 9, 2017
January 30, 2017
February 1, 2017
September 2014
September 2019   (Final data collection date for primary outcome measure)
  • Bladder Storage [ Time Frame: 5 years ]
    Bladder capacity (mlH2O)
  • Bladder Emptying [ Time Frame: 5 years ]
    Voiding Efficiency (% voided)
  • Bladder Pressure [ Time Frame: 5 years ]
    Leak point pressure (cmH2O)
  • Compliance [ Time Frame: 5 years ]
    Bladder Compliance (ml/cmH2O)
Bladder Function [ Time Frame: 5 years ]
Urodynamics
Complete list of historical versions of study NCT03036527 on ClinicalTrials.gov Archive Site
International Index of Erectile Function (IIEF), Female Sexual function index (FSFI) [ Time Frame: 5 years ]
International Spinal Cord Injury Data Set questionnaires for bladder and sexual function (male and female) also will be incorporated to assess management and dysfunction of these systems
Same as current
Not Provided
Not Provided
 
Recovery of Bladder and Sexual Function After Spinal Cord Injury
Effects of Activity Dependent Plasticity on Recovery of Bladder and Sexual Function After Human Spinal Cord Injury
Bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, Parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. Locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. In addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.
Objectives: To determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. Weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Spinal Cord Injuries
  • Procedure: Activity-based locomotor training
    The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).
    Other Name: Locomotor training
  • Procedure: Activity-based stand training
    The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.
    Other Name: Stand training
  • Procedure: Activity-based upper arm ergometry
    The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.
    Other Name: Arm Crank
  • Experimental: Activity-based locomotor training
    To understand the effects of weight-bearing activity-based locomotor therapy on bladder function and sexual function. Activity-based locomotor training interventions include locomotor step training with a harness and body-weight support, 5 days a week for a total of 80, 1-hour sessions.
    Intervention: Procedure: Activity-based locomotor training
  • Experimental: Activity-based stand training
    To understand the effects of weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based stand training interventions include stand training with a harness and body-weight support or stand training over ground, 5 days a week for a total of 80, 1-hour sessions.
    Intervention: Procedure: Activity-based stand training
  • Experimental: Activity-based upper arm ergometry
    To understand the effects of non-weight-bearing activity-based stand therapy on bladder and sexual function. Activity-based upper arm ergometry interventions may include arm crank training (upper arm ergometry) in while seated in the wheelchair 5 days a week for a total of 80, 1-hour sessions.
    Intervention: Procedure: Activity-based upper arm ergometry
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
September 2019
September 2019   (Final data collection date for primary outcome measure)

Criteria: Inclusion Criteria:

  • stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training
  • no painful musculoskeletal dysfunction,
  • unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training
  • no clinically significant depression or ongoing drug abuse;
  • clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation
  • non- progressive suprasacral spinal cord injury
  • bladder and sexual dysfunction as a result of spinal cord injury

Exclusion criteria:

  • unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training;
  • painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training
  • clinically significant depression or ongoing drug abuse;
  • clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation
  • progressive spinal cord injury
  • no bladder and sexual dysfunction as a result of spinal cord injury
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact: Charles Hubscher, PhD 502-852-3058 charles.hubscher@louisville.edu
Contact: Susan Harkema, PhD 502-581-8675 susanharkema@kentuckyonehealth.org
United States
 
 
NCT03036527
14.0062 Bladder Sex Fxn
Yes
Not Provided
Plan to Share IPD: No
Susan Harkema, University of Louisville
University of Louisville
Not Provided
Study Director: Ralph Nitkin, PhD National Institutes of Health (NIH)
University of Louisville
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP