Activity Dependent Rehabilitation Model to Improve Bone and Muscle Outcomes

NCT02309983 | Unknown

• 1 other identifier: 07-3063-SCR-E-0
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Disuse Osteoporosis; Atrophy, Disuse; Nervous System; Structural; Marker; Skeletal Muscle Hypertrophy

Keywords

bone turnover; muscle atrophy; fiber

Outcome Measures

Primary Outcomes (1)

• Bone Mineral density

  Collected at pre and post

  6 months

Secondary Outcomes (1)

• Muscle volume (MRI)

  6 months

Study Arms (3)

Electrical Stimulation Alone Group

ACTIVE COMPARATOR

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

Stand Retraining Alone with BWS

PLACEBO COMPARATOR

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)

Stand Retraining and ES Group

EXPERIMENTAL

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; Other: Stand Retraining with Body Weight Support (BWS)

Interventions

Electrical Stimulation OTHER

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.

Electrical Stimulation Alone Group; Stand Retraining and ES Group

Stand Retraining with Body Weight Support (BWS) OTHER

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.

Also known as: Locomotor Training

Stand Retraining Alone with BWS; Stand Retraining and ES Group

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Muscular Disorders, Atrophic; Neurologic Manifestations; Muscular Atrophy

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuromuscular Manifestations; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Gail Forrest, Ph.D

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gail F Forrest, PhD

CONTACT

973 324 3518; gforrest@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Director Human Performance Engineering Lab

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: December 5, 2014
• Study Start: December 1, 2006
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

US (1)