Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes

March 27, 2017 updated by: Gail Forrest, Kessler Foundation

Activity Dependent Rehabilitation Model In Incomplete Spinal Cord Injury: Neuromuscular and Skeletal Changes

For many after spinal cord injury (SCI) there is immobilization, muscle atrophy, bone loss, fracture risk during transferring (or falls), and the risk of secondary complications, and increase in attendance care and cost. It is important to develop multi dimensional rehabilitation strategies for people after SCI to enhance functional recovery towards walking, and enhance an increase in muscle and bone to potentially prepare the injured nervous system in the event of a cure. Locomotor training (Stand retraining and step re training) an activity-based rehabilitative approach generates muscle activity and provides weight bearing and joint contact kinetics, even in individuals who are unable to stand or step independently. Cross-sectional animal and human SCI studies have demonstrated that locomotor training (LT) (stand retraining and step retraining using body weight support treadmill training) has improved the capacity to stand independently and walk at faster speeds. Neuromuscular stimulation (NMS) or electrical stimulation (ES) training is a rehabilitative approach that generates muscle activity, alternating leg extension and flexion even in individuals who are unable to stand or step independently. NMS studies for individuals after SCI have shown improvements in bone density and muscle strength after cycling and resistance training. The main purpose of this study is to address whether stand retraining and NMS compared to stand retraining alone or NMS alone will increase neural and musculoskeletal gains and provide a greater functional recovery towards independent standing.

This project will be completed at two sites: Kessler Foundation Research Center (the grant PI site) and Frazier Rehabilitation Institute, University of Louisville, Kentucky.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

There will be three groups in this study. Each group will receive 1.25 hr of intervention per session, for a total of 60 sessions (3 - 4 x week, 15- 20 weeks). Participants in Group 1 will receive 1hr of ES while lying down in the chair followed by 15 min of overground training. Group 2 will receive standing retraining using BWS followed by 15 minutes of overground training. Group 3 will receive standing retraining with ES, followed by 15 min of overground training. Participants will complete the study after 20 weeks of training. The participant will be able to miss 8 consecutive training sessions before being dropped from the study.

PRIMARY AIMS

Specific Aim 1: To examine the effectiveness of standing retraining with ES for alterations in muscle volume (MV) and BMD in the lower limb:

Hypothesis 1.1. SRT with ES compared to SRT alone or ES alone will increase muscle volume(MV) and muscle cross sectional area(MCSA) and potential muscle torque(PMT) at hip, knee and ankle joints (compared to baseline).

Hypothesis 1.2. SRT with ES compared to SRT alone or ES alone will increase absolute BMD in the lower limbs(compared to baseline) Hypothesis 1.3. SRT with ES compared to SRT alone or ES alone will increase markers for bone formation and a decrease in markers for bone resorption commensurate with the observed increase in BMD (compared to baseline) SECONDARY AIMS Specific Aim 2 To examine the effectiveness of standing with ES for improvements in functional outcome and alterations in EMG in lower limb.

Hypothesis 2.1. SRT with ES compared with SRT alone or ES alone will improve functional performance(as measured by standing time on the treadmill and overground) Hypothesis 2.2. SRT with ES compared to SRT alone and ES alone will experience a greater increase in the electromyography (EMG) amplitude for all leg muscles examined (compared to baseline) during standing.

Hypothesis 2.3. LT with ES compared to SRT alone and ES alone will experience significantly greater cardiac output (CO) and/or stroke volume SV (compared to baseline).

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
21

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Must be between 18 and 58 years old with a neurological SCI level between the C6-T10 level and an impairment grade A, B, or C, according to the American Spinal Injury Association (ASIA) Impairment scale.
  • Must have a spinal cord injury that is greater than 6 month or less than 2 years post injury
  • Must have score less than 3 on the Modified Ashworth Scale.
  • Must be able to tolerate electrical stimulation and must show visible muscle contraction to electrical stimulus
  • Must be wheelchair reliant for more than 75% of the time

Exclusion Criteria:

  • Bone density measurement (as recorded by the researcher) for knee at or below 0.5755 gm/cm2
  • Weigh more than 225 Ibs.
  • Taller than 6 feet 3 inches
  • Post -menopausal, pregnant or a lactating woman.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Electrical Stimulation Alone Group
Group 1 will receive 1hr of electrical stimulation while lying down followed by 15 min of overground training. Electrical stimulation will be applied through leads and self-adhesive electrodes over muscles of both legs. Two electrodes will be used for each muscle. Electrical stimulation will be induced by using the EMPI, Inc., St. Paul, MN [Respond Select Neuromuscular Stimulation]. There will be 60 sessions/3x week for 20 weeks.
Other: Electrical Stimulation
Electrical stimulation is a rehabilitative approach that generates muscle activity by alternating leg extension and flexion even in individuals who are unable to stand or step independently. Electrical stimulation will be applied to multiple muscles of the lower limb.
Placebo Comparator: Stand Retraining Alone with BWS
Group 2 will receive standing retraining with BWS alone on a treadmill without functional electrical stimulation. Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. The duration of stand retraining sessions will be up to 1 hour or determined by subject's fatigue. There will be 60 sessions/3x week for 20 weeks.
Other: Stand Retraining with Body Weight Support (BWS)
Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion.
Other Names:
  • Locomotor Training
Experimental: Stand Retraining and ES Group
Group 3 will receive standing retraining with BWS with electrical stimulation, followed by 15 min of overground training. Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion. Electrical stimulation will start while participant is seated and before he/she is brought up to full standing. There will be 60 sessions/3x week for 20 weeks.
Other: Electrical Stimulation
Electrical stimulation is a rehabilitative approach that generates muscle activity by alternating leg extension and flexion even in individuals who are unable to stand or step independently. Electrical stimulation will be applied to multiple muscles of the lower limb.
Other: Stand Retraining with Body Weight Support (BWS)
Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion.
Other Names:
  • Locomotor Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Bone Mineral density
Time Frame: 6 months
Collected at pre and post
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle volume (MRI)
Time Frame: 6 months
Collected pre and post
6 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Craig H. Neilsen Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gail Forrest, Ph.D, Kessler Foundation

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2006

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 5, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 07-3063-SCR-E-0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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