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Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes

Primary Purpose

Disuse Osteoporosis, Atrophy, Disuse, Nervous System

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrical Stimulation
Stand Retraining with Body Weight Support (BWS)
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disuse Osteoporosis focused on measuring bone turnover, muscle atrophy, fiber

Eligibility Criteria

18 Years - 58 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Experimental

Arm Label

Electrical Stimulation Alone Group

Stand Retraining Alone with BWS

Stand Retraining and ES Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Bone Mineral density
Collected at pre and post

Secondary Outcome Measures

Muscle volume (MRI)
Collected pre and post

Full Information

First Posted
September 5, 2013
Last Updated
March 27, 2017
Sponsor
Kessler Foundation
Collaborators
The Craig H. Neilsen Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02309983
Brief Title
Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes
Official Title
Activity Dependent Rehabilitation Model In Incomplete Spinal Cord Injury: Neuromuscular and Skeletal Changes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
The Craig H. Neilsen Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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). .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disuse Osteoporosis, Atrophy, Disuse, Nervous System, Structural; Marker, Skeletal Muscle Hypertrophy
Keywords
bone turnover, muscle atrophy, fiber

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrical Stimulation Alone Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Stand Retraining Alone with BWS
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Stand Retraining and ES Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Electrical Stimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Stand Retraining with Body Weight Support (BWS)
Other Intervention Name(s)
Locomotor Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bone Mineral density
Description
Collected at pre and post
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Muscle volume (MRI)
Description
Collected pre and post
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
58 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gail F Forrest, PhD
Phone
973 324 3518
Email
gforrest@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gail Forrest, Ph.D
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Forrest, Ph.D
Phone
973-324-3518
Email
gforrest@kesslerfoundation.org

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes

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