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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Robotic exoskeleton training
Conventional physical therapy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Non-English speaking

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic exoskeleton training

Conventional Physical Therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
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.
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.
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).

Secondary Outcome Measures

Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis = palpable or visible contraction = active movement, full range of motion (ROM) with gravity eliminated = active movement, full ROM against gravity = active movement, full ROM against gravity and moderate resistance in a muscle specific position = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
Exoskeleton User Feedback as Assessed by a Questionnaire
A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.

Full Information

First Posted
January 3, 2017
Last Updated
March 5, 2018
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT03011099
Brief Title
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Official Title
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic exoskeleton training
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Physical Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Robotic exoskeleton training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
Description
The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Time Frame
baseline, week 4
Title
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
Description
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Time Frame
baseline, week 4
Title
Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
Description
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.
Time Frame
baseline, week 4
Title
Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Description
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.
Time Frame
baseline, week 4
Title
Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
Description
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).
Time Frame
baseline, week 4
Secondary Outcome Measure Information:
Title
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
Description
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
Time Frame
baseline, week 4
Title
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
Description
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
Time Frame
baseline, week 4
Title
Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
Description
Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
Time Frame
baseline, week 4
Title
Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Description
The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range: 0 = total paralysis = palpable or visible contraction = active movement, full range of motion (ROM) with gravity eliminated = active movement, full ROM against gravity = active movement, full ROM against gravity and moderate resistance in a muscle specific position = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.
Time Frame
baseline, week 4
Title
Exoskeleton User Feedback as Assessed by a Questionnaire
Description
A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
Time Frame
week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Davis, MD
Organizational Affiliation
The University of Texas Health Science Center, Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29556414
Citation
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.
Results Reference
derived

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

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