Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics
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|ClinicalTrials.gov Identifier: NCT03504826|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : March 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Device: Hybrid Assistive Limb (HAL)||Not Applicable|
The purpose of this study is to examine the safety and efficacy of locomotor training using adaptive robotics in adults with chronic SCI. Safety will be determined by monitoring of adverse responses such as skin irritation, pain, changes in spasticity and function. Preliminary efficacy for improving walking function will be determined by tests of walking speed and endurance prior to and following 60 daily sessions of locomotor training using adaptive robots.
Specific Aim 1: Test the hypothesis that locomotor training using adaptive robotics such as the Cyberdyne Hybrid Assistive Limb (HAL) is safe for individuals with chronic incomplete spinal cord injury (SCI). Safety will be demonstrated by an adverse response rate that does not exceed the frequency and severity of adverse responses reported for other well-established locomotor rehabilitation approaches. Safety will be assessed by monitoring of specific conditions such as skin integrity, pain, and spasticity.
Specific Aim 2: Test the hypothesis that locomotor training using adaptive robotics such as the Cyberdyne HAL (5x/week for 12 weeks, 60 sessions, 2 hours each) is efficacious for improving walking function in adults with chronic incomplete SCIs. Walking function may be assessed using standard clinical tests to measure walking speed and walking endurance. A battery of clinical tests (listed in Outcome Measures) will be selected for use based on each participant's functional capabilities.
To address the aims of the study, the investigators will use a pre-post repeated measures study design. Following phone and in-person screenings and physician approval, individuals will provide informed consent to the study procedures. Non-invasive tests of physical function and health will be conducted prior to and following 60 sessions of locomotor training using the HAL, an adaptive robotic device that is custom fitted to each individual to provide assistance to the lower limbs during locomotor training.
Subject recruitment: Individuals with chronic SCI (>1 year) who meet the given enrollment criteria (see inclusion and exclusion criteria) will be included for this study. Recruitment will occur from within the Brooks Health System which includes the Brooks Cybernic Treatment Center, as well as from their healthcare providers and advertisements in the community.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Walking Rehabilitation After Spinal Cord Injury: Locomotor Training Using Adaptive Robotics|
|Actual Study Start Date :||November 29, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: Locomotor training using adaptive robot
The intervention will consist of 60 sessions of locomotor training using the HAL adaptive robot. The training sessions will be scheduled 5 days per week for 12 weeks. A physical therapist with expertise in SCI walking rehabilitation and use of the HAL will oversee all intervention sessions. The intervention sessions will include up to a total of 40 minutes of stepping time, which may take up to 2 hours to complete due to set up time and rest breaks.
Device: Hybrid Assistive Limb (HAL)
Intensive training with the HAL consisting of two components to the intervention session that include: 1) locomotor treadmill training with the HAL device and 2) locomotor training over ground without the HAL device. All training will be overseen by a licensed physical therapist.
- 10-Meter Walk Test (10MWT) [ Time Frame: Daily and change in baseline to weeks 6 and 12 ]Performance assessment of comfortable and fastest safe walking speed for 10 meters. A reduced time (in seconds) to complete the 10-Meter Walk Test reflects improvement in walking function.
- 6-Minute Walk Test (6MWT) [ Time Frame: Daily and change in baseline to weeks 6 and 12 ]Performance assessment of walking endurance for 6 minutes. An increase in the number of meters walked during this assessment reflects an improvement in walking endurance.
- Electromyogram (EMG) will be used to assess the neuromuscular activation of the lower extremities [ Time Frame: Change in baseline to week 12 ]A wireless, 16-channel EMG system will be applied at various key muscle groups on both lower extremities. Greater amplitude or changes in activation timing in the EMG signal will reflect improvement in muscle activation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504826
|Contact: Emily J Fox, DPT, PhDfirstname.lastname@example.org|
|Contact: Lou DeMark, DPT, NCSemail@example.com|
|United States, Florida|
|Jacksonville, Florida, United States, 32216|
|Contact: Emily J Fox, DPT,PhD 352-273-6117 firstname.lastname@example.org|
|Principal Investigator: Emily J Fox, DPT, PhD|
|Sub-Investigator: Lou DeMark, DPT, NCS|
|Sub-Investigator: Christy Conroy, MSPT, NCS|
|Sub-Investigator: David Clark, ScD|
|Sub-Investigator: Geneva Jacobs, MD|
|Principal Investigator:||Emily J Fox, DPT, PhD||Brooks Rehabilitation|