Recovery of Bladder and Sexual Function After Spinal Cord Injury

NCT ID: NCT03036527

Last Updated: 2024-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-11-30

Brief Summary

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.

Detailed Description

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.

Conditions

Spinal Cord Injuries

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Activity-based locomotor training

Intervention Type: PROCEDURE

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).

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.

Group Type: EXPERIMENTAL

Activity-based stand training

Intervention Type: PROCEDURE

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.

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.

Group Type: EXPERIMENTAL

Activity-based upper arm ergometry

Intervention Type: PROCEDURE

The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.

Activity based training + spinal epidural stimulation

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Group Type: EXPERIMENTAL

Activity-based locomotor training

Intervention Type: PROCEDURE

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).

Activity-based stand training

Intervention Type: PROCEDURE

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.

Activity-based training + spinal epidural stimulation

Intervention Type: PROCEDURE

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Interventions

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).

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Activity-based training + spinal epidural stimulation

combination effect of both locomotor training and/or stand training with epidural stimulation targeting locomotion and/or stand.

Intervention Type: PROCEDURE

Other Intervention Names

Locomotor training; Stand training; Arm Crank

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Susan Harkema PhD

Professor and Associate Director, Kentucky Spinal Cord Injury Research Center, University of Louisville Owsley B. Frazier Chair in Neurological Rehabilitation Research Director, Frazier Rehab Institute Director of the NeuroRecovery Network

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ralph Nitkin, PhD

Role: STUDY_DIRECTOR

National Institutes of Health (NIH)

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

References

Hubscher CH, Wyles J, Gallahar A, Johnson K, Willhite A, Harkema SJ, Herrity AN. Effect of Different Forms of Activity-Based Recovery Training on Bladder, Bowel, and Sexual Function After Spinal Cord Injury. Arch Phys Med Rehabil. 2021 May;102(5):865-873. doi: 10.1016/j.apmr.2020.11.002. Epub 2020 Dec 3.

Reference Type: DERIVED

PMID: 33278365 (View on PubMed)

Hubscher CH, Herrity AN, Williams CS, Montgomery LR, Willhite AM, Angeli CA, Harkema SJ. Improvements in bladder, bowel and sexual outcomes following task-specific locomotor training in human spinal cord injury. PLoS One. 2018 Jan 31;13(1):e0190998. doi: 10.1371/journal.pone.0190998. eCollection 2018.

Reference Type: DERIVED

PMID: 29385166 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5R01HD080205

Identifier Type: NIH

Identifier Source: secondary_id

View Link

14.0062 Bladder Sex Fxn

Identifier Type: -

Identifier Source: org_study_id