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Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes

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ClinicalTrials.gov Identifier: NCT02309983
Recruitment Status : Recruiting
First Posted : December 5, 2014
Last Update Posted : March 28, 2017
Sponsor:
Collaborator:
The Craig H. Neilsen Foundation
Information provided by (Responsible Party):
Gail Forrest, Kessler Foundation

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Disuse Osteoporosis Atrophy, Disuse Nervous System Structural; Marker Skeletal Muscle Hypertrophy Other: Electrical Stimulation Other: Stand Retraining with Body Weight Support (BWS) Not Applicable

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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Activity Dependent Rehabilitation Model In Incomplete Spinal Cord Injury: Neuromuscular and Skeletal Changes
Study Start Date : December 2006
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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 Name: 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 Name: Locomotor Training




Primary Outcome Measures :
  1. Bone Mineral density [ Time Frame: 6 months ]
    Collected at pre and post


Secondary Outcome Measures :
  1. Muscle volume (MRI) [ Time Frame: 6 months ]
    Collected pre and post



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 58 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02309983


Contacts
Contact: Gail F Forrest, PhD 973 324 3518 gforrest@kesslerfoundation.org

Locations
United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Forrest, Ph.D    973-324-3518    gforrest@kesslerfoundation.org   
Sponsors and Collaborators
Kessler Foundation
The Craig H. Neilsen Foundation
Investigators
Principal Investigator: Gail Forrest, Ph.D Kessler Foundation

Responsible Party: Gail Forrest, Assistant Director Human Performance Engineering Lab, Kessler Foundation
ClinicalTrials.gov Identifier: NCT02309983     History of Changes
Other Study ID Numbers: 07-3063-SCR-E-0
First Posted: December 5, 2014    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Gail Forrest, Kessler Foundation:
bone turnover
muscle atrophy
fiber

Additional relevant MeSH terms:
Muscular Disorders, Atrophic
Muscular Diseases
Neuromuscular Diseases
Osteoporosis
Atrophy
Hypertrophy
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Pathological Conditions, Anatomical
Nervous System Diseases