Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

NCT ID: NCT01740128

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-01
• Study Completion Date: 2017-10-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Multimodal then Treadmill training

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.

Group Type: EXPERIMENTAL

Robotic body weight supported treadmill training

Intervention Type: DEVICE

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

Harness-supported multimodal balance training

Intervention Type: OTHER

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

Treadmill then Multimodal training

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.

Group Type: ACTIVE_COMPARATOR

Robotic body weight supported treadmill training

Intervention Type: DEVICE

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

Harness-supported multimodal balance training

Intervention Type: OTHER

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

Interventions

Robotic body weight supported treadmill training

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

Intervention Type: DEVICE

Harness-supported multimodal balance training

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

Intervention Type: OTHER

Other Intervention Names

Lokomat; balance exercises, skilled hand exercises

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• Unsuitable cognitive capacity as judged by the study physician;
• Diagnosis of neurological injury other than SCI, such as stroke, traumatic brain injury, or other neurological condition that the study physician considers to be exclusionary;
• 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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noam Y Harel, MD PhD

Role: PRINCIPAL_INVESTIGATOR

James J. Peters Veterans Affairs Medical Center

Locations

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23809527 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25771437 (View on PubMed)

Other Identifiers

5IK2RX000881-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

01407

Identifier Type: OTHER

Identifier Source: secondary_id

SPU-11-077

Identifier Type: OTHER

Identifier Source: secondary_id

B0881-W

Identifier Type: -

Identifier Source: org_study_id