Recruiting

Rehabilitation Model

Sponsor:

Kessler Foundation

Code:

NCT02309983

Conditions

Disuse Osteoporosis

Atrophy, Disuse

Nervous System

Structural; Marker

Skeletal Muscle Hypertrophy

Eligibility Criteria

Sex: All

Age: 18 - 58

Healthy Volunteers: Not accepted

Interventions

Electrical Stimulation

Stand Retraining with Body Weight Support (BWS)

Study Details

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

Study ID

NCT02309983

Start date

Dec, 2006

Status verified date

Mar, 2017

Completion date

Dec, 2018

Anticipated

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 58

Healthy Volunteers: Not accepted

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 Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

Interventions

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.

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.

Primary outcome measure

  • Bone Mineral density [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 28, 2017

Last verified

Mar, 2017

Keywords

  • bone turnover
  • muscle atrophy
  • fiber

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2017-03-28.