Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

NCT03011099 | Completed Results

• 1 other identifier: HSC-MS-13-0536
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test

  The 10 Meter Walk Test assesses the time taken to walk 10 meters.

  baseline, week 4

• Change in Walking Endurance as Assessed by the 6 Minute Walk Test

  The 6 Minute Walk Test assesses the distance walked in 6 minutes.

  baseline, week 4

• Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test

  The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.

  baseline, week 4

• Change in Muscle Activity as Assessed by Surface Electromyography (EMG)

  Surface EMG sensors will be placed on the skin of subjects' lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.

  baseline, week 4

• Change in Energy Expenditure During Walking as Assessed by Oxygen Cost

  Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).

  baseline, week 4

Secondary Outcomes (5)

• Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)

  baseline, week 4

• Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)

  baseline, week 4

• Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)

  baseline, week 4

• Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)

  baseline, week 4

• Exoskeleton User Feedback as Assessed by a Questionnaire

  week 4

Study Arms (2)

Robotic exoskeleton training

EXPERIMENTAL

During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.

Device: Robotic exoskeleton training

Conventional Physical Therapy

ACTIVE COMPARATOR

During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.

Other: Conventional physical therapy

Interventions

Robotic exoskeleton training DEVICE

During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.

Robotic exoskeleton training

Conventional physical therapy OTHER

During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.

Conventional Physical Therapy

Eligibility Criteria

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

You may qualify if:

• Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
• Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
• Male or non-pregnant woman
• ≥ 18-years of age
• At least 6 months after injury
• Height between 5'2" and 6'2" (150-188 cm)
• Weight ≤ 220 pounds (100 kg)
• Ability to perform informed consent

You may not qualify if:

• Presence of clinical signs of lower motor neuron injury
• History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
• Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
• Documented severe osteoporosis affecting the hip and spine
• Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
• Unstable spine
• Unhealed limb or pelvic fractures
• Skin issues that would prevent wearing the device
• Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
• Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
• Heterotopic ossification that resists functional range of motion in lower extremities
• Contractures (\>15 degrees at the hips or \>20 degrees at the knees)
• Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
• Colostomy
• Have received any physical therapy intervention within 3 months prior to enrolment in the study

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Chang SH, Afzal T; TIRR SCI Clinical Exoskeleton Group; Berliner J, Francisco GE. Exoskeleton-assisted gait training to improve gait in individuals with spinal cord injury: a pilot randomized study. Pilot Feasibility Stud. 2018 Mar 5;4:62. doi: 10.1186/s40814-018-0247-y. eCollection 2018.

  PMID: 29556414 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Chang, Shuo-Hsiu, PT, PhD
• Organization: UT health PM&R

Shuo-Hsiu.Chang@uth.tmc.edu

713-799-7016

Study Officials

• Matthew Davis, MD

  The University of Texas Health Science Center, Houston

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 5, 2017
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Locations

US (1)