Spinal Cord Injuries
Conditions
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.
Interventions
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.
OTHERConventional physical therapy
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.
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Energy Expenditure During Walking as Assessed by Oxygen Cost | baseline, week 4 | 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). |
| Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test | baseline, week 4 | 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 | baseline, week 4 | 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 | baseline, week 4 | 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) | baseline, week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) | baseline, week 4 | 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) | baseline, week 4 | 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) | baseline, week 4 | 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) | baseline, week 4 | 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 1. = palpable or visible contraction 2. = active movement, full range of motion (ROM) with gravity eliminated 3. = active movement, full ROM against gravity 4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position 5. = (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 | week 4 | 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. |
Countries
United States
Participant flow
Pre-assignment details
One participant dropped out of the study after signing the consent before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Robotic Exoskeleton Training 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. | 6 |
| Conventional Physical Therapy 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. | 3 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Robotic Exoskeleton Training | Conventional Physical Therapy | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment United States | 6 participants | 3 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 3 |
| other Total, other adverse events | 1 / 6 | 0 / 3 |
| serious Total, serious adverse events | 0 / 6 | 0 / 3 |
Outcome results
Primary
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.
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test | -10.575 Second | Standard Deviation 17.31 |
| Conventional Physical Therapy | Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test | -1.59 Second | Standard Deviation 0.44 |
Primary
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).
Time frame: baseline, week 4
Population: The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Energy Expenditure During Walking as Assessed by Oxygen Cost | -0.84 ml/min/kg | Standard Deviation 0.56 |
Primary
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.
Time frame: baseline, week 4
Population: This measure was later added to the protocol and hence data was collected from one participant only.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in soleus activity | -44 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in gastrocnemius activity | -37 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in tibialis anterior activity | 57 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in Rectus Femoris activity | 12 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in Vastus Medialis activity | -18 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in Bicep Femoris activity | 33 percentage of muscle activity change |
| Robotic Exoskeleton Training | Change in Muscle Activity as Assessed by Surface Electromyography (EMG) | Change in Semitendinosus activity | 32 percentage of muscle activity change |
Primary
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.
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test | -6.815 seconds | Standard Deviation 9.58 |
| Conventional Physical Therapy | Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test | -0.5 seconds | Standard Deviation 4.02 |
Primary
Change in Walking Endurance as Assessed by the 6 Minute Walk Test
The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Walking Endurance as Assessed by the 6 Minute Walk Test | 34.3833 feet | Standard Deviation 42.83 |
| Conventional Physical Therapy | Change in Walking Endurance as Assessed by the 6 Minute Walk Test | 25.3 feet | Standard Deviation 25.96 |
Secondary
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.
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) | 0.12 steps/min | Standard Deviation 0.17 |
| Conventional Physical Therapy | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence) | 0.08 steps/min | Standard Deviation 0.11 |
Secondary
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.
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) | 0.04 cm | Standard Deviation 0.11 |
| Conventional Physical Therapy | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length) | -0.03 cm | Standard Deviation 0.08 |
Secondary
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).
Time frame: baseline, week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) | -0.09 seconds | Standard Deviation 0.13 |
| Conventional Physical Therapy | Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time) | -0.02 seconds | Standard Deviation 0.11 |
Secondary
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 1. = palpable or visible contraction 2. = active movement, full range of motion (ROM) with gravity eliminated 3. = active movement, full ROM against gravity 4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position 5. = (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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) | 0.42 units on a scale | Standard Deviation 2.15 |
| Conventional Physical Therapy | Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS) | -0.17 units on a scale | Standard Deviation 0.41 |
Secondary
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.
Time frame: week 4
Population: This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Robotic Exoskeleton Training | Exoskeleton User Feedback as Assessed by a Questionnaire | 1.83 units on a scale | Standard Deviation 0.75 |