Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

NCT01740128 | Completed Results FDA Device

• 4 other identifiers: B0881-W5IK2RX000881-0301407SPU-11-077
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Many people with spinal cord injury (SCI) retain at least some movement below their injury, but their muscles often have a 'mind of their own'. Typical exercise programs focus on keeping muscles strong and flexible, but don't usually focus on helping patients control their muscles. The investigators' exercise research study will compare two different programs with the specific goal of improving conscious control of patients' muscles below the injury. This study focuses on those with 'chronic' SCI - the injury occurred at least one year prior to enrolling. This is a single center study taking place in the Bronx, NY. The first phase of the study will be observational - the investigators will analyze which nerve connections might remain partially intact through the injury (even if the nerves aren't consciously controlled). Participants with all severity of SCI may participate in this first phase. The second phase of the study will involve people who retain at least slight ability to move their legs and the ability to move the arms against gravity. Each person will undergo two different exercise rehabilitation strategies: weight-supported treadmill training; and balance training combined with skilled arm or hand exercises. The investigators will compare the effects of these exercise programs on a variety of outcomes, including gait speed, balance, strength, and muscle activation in response to brain stimulation. The investigators hypothesize that participants with chronic SCI undergoing combined balance/arm/hand training will show improved outcomes when compared to traditional gait or balance training.

Conditions

Spinal Cord Injuries; Paraplegia; Paraparesis

Keywords

spinal cord injuries; paraplegia; postural balance; locomotor activity; exercise therapy; electromyography; transcranial magnetic stimulation, single pulse

Outcome Measures

Primary Outcomes (1)

• Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.

  Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

Secondary Outcomes (10)

• Change From Baseline in ISNCSCI Lower Extremity Motor Score.

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

• Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

• Change in Leg Spasticity on Modified Ashworth Scale

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

• Change in Gait Speed on 10-meter Walk Test.

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

• Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.

  Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)

Study Arms (2)

Multimodal then Treadmill training

EXPERIMENTAL

Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Device: Robotic body weight supported treadmill training; Other: Harness-supported multimodal balance training

Treadmill then Multimodal training

ACTIVE COMPARATOR

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Device: Robotic body weight supported treadmill training; Other: Harness-supported multimodal balance training

Interventions

Robotic body weight supported treadmill training DEVICE

30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Also known as: Lokomat

Multimodal then Treadmill training; Treadmill then Multimodal training

Harness-supported multimodal balance training OTHER

30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Also known as: balance exercises, skilled hand exercises

Multimodal then Treadmill training; Treadmill then Multimodal training

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females age 21-65 years;
• SCI duration \> 12 months;
• SCI level C2-T12;
• All SCI severity eligible for baseline testing;
• For exercise protocol, must have severity of Grade C or D on American Spinal Injury Association (ASIA) Impairment Scale, or volitional strength of at least 1/5 in two or more key lower extremity muscles, as well as at least 3/5 in both shoulder and elbow muscles;
• Able to tolerate upright position with support;
• Morphologically capable of fitting a weight-support harness and robotic treadmill system;
• Ability to give informed consent.

You may not qualify if:

• Unsuitable cognitive capacity as judged by the study physician;
• Multiple spinal cord lesions;
• History of frequent autonomic dysreflexia;
• History of seizures;
• Use of medications that significantly lower seizure threshold, such as anti-psychotics, tricyclic antidepressants, amphetamines, and bupropion;
• History of implanted brain/spine/nerve stimulators, aneurysm clips, or cardiac pacemaker/defibrillator;
• Deep vein thrombosis in lower extremities of less than 6 months duration;
• Pregnancy;
• (Interventional phase only): Lack of detectable tibialis anterior motor evoked potential (MEP) at baseline even with active facilitation;
• (Interventional phase only): Pressure ulcers greater than stage 1 severity on the foot, ankle, knee and/or pelvic girdle;
• (Interventional phase only): Bone mineral density of the hip (proximal femur) T-score \<3.5 standard deviations from age- and gender-matched normative data;
• (Interventional phase only): Any spasticity, contractures, or heterotopic ossification that result in inadequate range of motion of the shoulder, elbow, wrist, fingers, hip, knee, or ankle joints in the judgment of the study physician;
• (Interventional phase only): Inability to cooperate with instructions or unwilling to commit to daily training sessions for 3-4 days per week over 12-16 weeks;
• (Interventional phase only): A diagnosis of coronary artery disease that precludes moderate to intense exercise.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Related Publications (2)

• Harel NY, Asselin PK, Fineberg DB, Pisano TJ, Bauman WA, Spungen AM. Adaptation of computerized posturography to assess seated balance in persons with spinal cord injury. J Spinal Cord Med. 2013 Mar;36(2):127-33. doi: 10.1179/2045772312Y.0000000053.

  PMID: 23809527 BACKGROUND

• Harel NY, Martinez SA, Knezevic S, Asselin PK, Spungen AM. Acute changes in soleus H-reflex facilitation and central motor conduction after targeted physical exercises. J Electromyogr Kinesiol. 2015 Jun;25(3):438-43. doi: 10.1016/j.jelekin.2015.02.009. Epub 2015 Mar 2.

  PMID: 25771437 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Paraparesis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paresis

Limitations and Caveats

Smaller than expected enrollment, high dropout rate.

Results Point of Contact

• Title: Noam Y. Harel, MD, PhD
• Organization: James J. Peters VAMC

noam.harel@va.gov

718-584-9000

Study Officials

• Noam Y Harel, MD PhD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2012
• First Posted: December 4, 2012
• Study Start: January 1, 2013
• Primary Completion: November 30, 2016
• Study Completion: October 23, 2017
• Last Updated: February 26, 2018
• Results First Posted: February 26, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)