Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

Official title:

A Hebbian Approach to Regaining Control of Spared Circuits in Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740128
• Other study ID #: B0881-W
• Secondary ID: 5IK2RX000881-030
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: January 26, 2018
• Start date: January 1, 2013
• Est. completion date: October 23, 2017

Study information

• Verified date: January 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: October 23, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paraparesis
• Paraplegia
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in ISNCSCI Lower Extremity Motor Score.	Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.	Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change in Leg Spasticity on Modified Ashworth Scale	Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change in Gait Speed on 10-meter Walk Test.	Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.	Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.	Change between baseline and Evaluation #2 in steps taken during 10-second step test.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).	Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.	Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.	Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Change From Baseline in Soleus H-reflex Facilitation.	Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.	Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Secondary	Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)	Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.	Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)