StrokeREALNCT04818424
Robotic Exosuit Augmented Locomotion (REAL)
A study testing Soft exosuit and Gait training without exosuits in people with Stroke, run by Lou Awad, PT, DPT, PhD at 3 sites in United States.
Trial summary
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Soft exosuit and Gait training without exosuits
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- 24 Feb 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Gait speed equal to or less than 1 m/s
- Able to walk without the support of another person for at least 6 minutes (may use an assistive device as needed, but without use of an ankle foot orthosis or brace)
- Passive ankle dorsiflexion range of motion to neutral with the knee extended (i.e., able to achieve an angle of 90 degrees between the shank and the foot)
- Resting heart rate between 40 - 100 bpm, inclusive
- Resting blood pressure between 90/60 and 170/90 mmHg, inclusive
Who cannot join
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Actively receiving physical therapy for walking
- History of cerebellar strokes
- Known recurring or repeating strokes
Show all 9Show fewer
- Unexplained dizziness in the last 6 months
- Pressure ulcers or skin wounds located at human-device interface sites
- Other medical, orthopedic, and neurological conditions that prevent full participation in the research
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard University
Boston, Massachusetts, 02134
Boston University
Boston, Massachusetts, 02215
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129
About this study
Official title: Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce long-lasting gait restoration. Current gait training efforts are focused on either quality or intensity. They focus on gait quality often by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without focusing on the quality of their movements. These intervention paradigms generally fail to substantially impact community mobility. In this study, the investigators posit that exosuits can uniquely enable an integration of these paradigms (ie, high intensity gait training that promotes quality of movements). For this protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will be used. To evaluate the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics and energetics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that we will collect will enable us to understand more comprehensively the gait-restorative effects of REAL.
Read the detailed description
Weakness of the ankle plantarflexors after a stroke results in impaired forward propulsion during walking, which consequently impacts walking efficiency and speed - parameters that are necessary for community participation. Next-generation soft, wearable robots, known as soft robotic exosuits, were developed to assist paretic ankle dorsiflexion during its swing phase and paretic ankle plantarflexion during push off. Prior observational studies of the exosuit technology have culminated in strong evidence of immediate gait-restorative effects for patients post-stroke through improved forward propulsion, and faster and farther walking. The investigators posit that gait training using exosuits will leverage these immediate gait-restorative effects to facilitate gait training at higher intensities without compromising gait quality. This type of training will facilitate lasting rehabilitative effects that persist beyond the use of exosuit. Leveraging a systematic approach in the staging of pilot studies toward larger clinical trials, this clinical validation was initiated with a single-subject study design followed by a case series, which both provided early evidence for the potential of gait training with exosuits in restoring propulsion and speed. As a next step, the investigators seek to examine the efficacy of these interventions under more robust terms by implementing a randomized clinical trial (RCT).
The primary aim of the current study seeks to understand the rehabilitative effects of a Robotic Exosuit Augmented Locomotion (REAL) gait training program relative to matched gait training without exosuits (Control) on walking and propulsion function after stroke. It is hypothesized that REAL training will result in clinically meaningful improvements in walking speed that are greater than the speed gains following Control training. Further, this study seeks to examine whether training-related changes in propulsion function following both interventions (REAL, Control) influence the training-induced effects on walking function. The investigators hypothesize that REAL training will result in substantial gains in walking function that are achieved through improved propulsion function, while Control training will have modest gains in walking function that are not related to changes in propulsion.
A secondary aim of this study is to evaluate single day changes in neuromuscular control following both interventions (REAL, Control), as measured by muscle synergies and the dynamic motor control index. The investigators hypothesize that neuromuscular control will immediately improve during powered use of a soft-robotic exosuit (i.e., immediate) and exosuit-induced improvements in neuromuscular control will show continued improvement over a single session of REAL gait training (i.e., adaptation), and persisting improvement to unassisted walking after a single session of REAL gait training (i.e., retention). In contrast, the Control training will show no changes in neuromuscular control. An additional secondary aim is to identify neuromuscular predictors of training-related improvements in walking and propulsion function. It is hypothesized that positive relationships will be observed between single-day changes in neuromuscular control and training-induced improvements in walking and propulsion function after 12 sessions of gait training. Moreover, the investigators hypothesize that regardless of baseline walking speed, individuals with higher baseline neuromuscular control will have the greatest training-induced improvements in propulsion and walking function after 12 sessions of gait training.
For this protocol, exosuits developed in collaboration with an industry partner (ReWalk™ Robotics) will be used. To examine the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that will be collected will enable a more comprehensive understanding of the gait-restorative effects of REAL.
This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical screen \& fit, (3) Exposure, (4) Pre-training evaluations, (5) Training (12 sessions)(6) Post-training evaluation, and (7) Retention evaluation. Randomization to either REAL or Control will occur after Pre-training evaluation. A washout period up to 4 weeks will precede Retention evaluation.
- Conditions
- Stroke
- Being tested
- Soft exosuit, Gait training without exosuits
- Keywords
- Exosuit, Soft Robotics, Wearable Robots, Gait Rehabilitation, Propulsion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soft exosuitDevice
A soft exosuit is a textile-based wearable robot that is worn on the paretic ankle. Soft exosuits provide assistive torques through retraction of Bowden cables that connect distally to anchor points on front and back of the ankle, assisting with dorsiflexion during swing for foot clearance, and plantarflexion during late stance to assist with propulsion, respectively. Exosuit assistance is provided synchronously based on the wearer's gait, as detected by integrated inertial measurement units.
Gait training without exosuitsBehavioural
Control intervention will implement gait training without exosuits. Other elements of intervention are similarly structured as with REAL, with the only exception of using exosuits.
| Study group | Role | What they receive |
|---|---|---|
| REAL training | Experimental | Robotic Exosuit Augmented Locomotion (REAL) refers to gait training with soft robotic exosuits, performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by the physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. REAL includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time. Receives: Device: Soft exosuit |
| Control training | Active comparator | Control training refers to similarly structured gait training as with REAL, with the only exception of using soft robotic exosuits. Control training is performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. Control training includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time. Receives: Behavioral: Gait training without exosuits |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
Measured: Baseline (Pre-training Evaluation)
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
Measured: Post-training Evaluation (up to 6 weeks)
6-Minute Walk Test (6MWT)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
Measured: Retention Evaluation (up to 4 weeks post-washout)
10-Meter Walk Test (10MWT)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
Measured: Baseline (Pre-training Evaluation)
10-Meter Walk Test (10MWT)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
Measured: Post-training Evaluation (up to 6 weeks)
10-Meter Walk Test (10MWT)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
Measured: Retention Evaluation (up to 4 weeks post-washout)
Secondary outcomes (5)
Forward propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Measured: Baseline (Pre-training Evaluation)
Forward propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Measured: Post-training Evaluation (up to 6 weeks)
Forward propulsion
Forward propulsion refers to anterior component of the ground reaction forces that correspond to push-off subtask of the gait cycle.
Measured: Retention Evaluation (up to 4 weeks post-washout)
Muscle Synergies
Muscle synergies refers to the coordinated co-activation of muscles during walking. Electromyography data will be collected bilaterally from up to 12 lower-limb muscles during treadmill walking with and without the exosuit. The number, timing, and composition of muscle synergies will be calculated using standard non-negative matrix factorization techniques.
Measured: Baseline (Pre-training Evaluation)
Dynamic Motor Control Index
The dynamic motor control index is a continuous summary metric of muscle co-activations during walking. Electromyography data will be collected bilaterally from up to 12 lower-limb muscles during treadmill walking with and without the exosuit. Using non-negative matrix factorization, the variability accounted for by the one-muscle synergy solution is converted into a z-score centered around 100. A value of 100 indicates neuromuscular control similar to neuro-typical adults and each 10-point deviation represents a difference of one-standard deviation from neuro-typical adults.
Measured: Baseline (Pre-training Evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start24 Feb 2021 (estimated)
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: Investigators elected to implement a staged approach, conducting a mechanistic clinical trial first before proceeding with a randomized controlled trial. Consequently, this study is withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either intervention of (1) REAL, or (2) Control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lou Awad, PT, DPT, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Spaulding Rehabilitation Hospital
- Responsible party
- Sponsor-investigator, Lou Awad, PT, DPT, PhD, Boston University Charles River Campus
- Investigators
- Lou Awad, PT, DPT, PhD, Principal investigator, Boston University Charles River Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818424
- Sponsor's protocol ID
- 5520
- Acronym
- REAL
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2021
- Last updated
- 4 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Awad LN, Bae J, O'Donnell K, et al. Soft exosuits increase walking speed and distance after stroke. In: International Symposium on Wearable Robotics and Rehabilitation (WeRob). Houston, TX: IEEE; 2; 2017.
Awad LN, Bae J, Kudzia P, Long A, Hendron K, Holt KG, O'Donnell K, Ellis TD, Walsh CJ. Reducing Circumduction and Hip Hiking During Hemiparetic Walking Through Targeted Assistance of the Paretic Limb Using a Soft Robotic Exosuit. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S157-S164. doi: 10.1097/PHM.0000000000000800.
PubMed 28777105Awad LN, Bae J, O'Donnell K, De Rossi SMM, Hendron K, Sloot LH, Kudzia P, Allen S, Holt KG, Ellis TD, Walsh CJ. A soft robotic exosuit improves walking in patients after stroke. Sci Transl Med. 2017 Jul 26;9(400):eaai9084. doi: 10.1126/scitranslmed.aai9084.
PubMed 28747517Bae J, Awad LN, Long A, O'Donnell K, Hendron K, Holt KG, Ellis TD, Walsh CJ. Biomechanical mechanisms underlying exosuit-induced improvements in walking economy after stroke. J Exp Biol. 2018 Mar 7;221(Pt 5):jeb168815. doi: 10.1242/jeb.168815.
PubMed 29361587Ardestani MM, Kinnaird CR, Henderson CE, Hornby TG. Compensation or Recovery? Altered Kinetics and Neuromuscular Synergies Following High-Intensity Stepping Training Poststroke. Neurorehabil Neural Repair. 2019 Jan;33(1):47-58. doi: 10.1177/1545968318817825. Epub 2018 Dec 29.
PubMed 30595090Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
PubMed 24515925Hesse S, Bertelt C, Jahnke MT, Schaffrin A, Baake P, Malezic M, Mauritz KH. Treadmill training with partial body weight support compared with physiotherapy in nonambulatory hemiparetic patients. Stroke. 1995 Jun;26(6):976-81. doi: 10.1161/01.str.26.6.976.
PubMed 7762049Paci M. Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies. J Rehabil Med. 2003 Jan;35(1):2-7. doi: 10.1080/16501970306106.
PubMed 12610841Ardestani MM, Henderson CE, Hornby TG. Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics. J Biomech. 2019 Jun 25;91:151-159. doi: 10.1016/j.jbiomech.2019.05.011. Epub 2019 May 17.
PubMed 31122660Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.
PubMed 30408710Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.
PubMed 16456121Bae J, Siviy C, Rouleau M, et al. A lightweight and efficient portable soft exosuit for paretic ankle assistance in walking after stroke. Proc - IEEE Int Conf Robot Autom. 2018:2820-2827. doi:10.1109/ICRA.2018.8461046
Awad LN, Kudzia P, Revi DA, Ellis TD, Walsh CJ. Walking faster and farther with a soft robotic exosuit: Implications for post-stroke gait assistance and rehabilitation. IEEE Open J Eng Med Biol. 2020;1:108-115. doi: 10.1109/ojemb.2020.2984429. Epub 2020 Apr 2.
PubMed 33748765Dobkin BH. Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):197-206. doi: 10.1177/1545968309331863.
PubMed 19240197Porciuncula F, Baker TC, Arumukhom Revi D, et al. Soft robotic exosuits for targeted gait rehabilitation after stroke: A case study. Neurorehabil Neural Repair. 2019;33(12):1082-1083.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Exosuit Augmented Locomotion (REAL) in the Clinic and Community
- ClinicalTrials.gov ID
- NCT04818424
- Acronym / sponsor ID
- REAL / 5520
- Conditions
- Stroke
- Keywords
- Exosuit, Soft Robotics, Wearable Robots, Gait Rehabilitation, Propulsion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigators elected to implement a staged approach, conducting a mechanistic clinical trial first before proceeding with a randomized controlled trial. Consequently, this study is withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lou Awad, PT, DPT, PhDUniversity, hospital or other
- Collaborators
- Harvard University, Spaulding Rehabilitation Hospital
- Study start
- 24 Feb 2021 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies of the exosuit technology have culminated in strong evidence for the gait-restorative effects of soft robotic exosuits for patients post-stroke by means of substitution for lost function. The present study builds on this work by suggesting that an exosuit's immediate gait-restorative effects can be leveraged during high intensity gait training to produce long-lasting gait restoration. Current gait training efforts are focused on either quality or intensity. They focus on gait quality often by reducing the training intensity to allow patients to achieve a more normal gait. In contrast, efforts focused on training intensity push participants without focusing on the quality of their movements. These intervention paradigms generally fail to substantially impact community mobility. In this study, the investigators posit that exosuits can uniquely enable an integration of these paradigms (ie, high intensity gait training that promotes quality of movements). For this protocol, exosuits developed in collaboration with an industry partner, ReWalk™ Robotics will be used. To evaluate the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics and energetics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that we will collect will enable us to understand more comprehensively the gait-restorative effects of REAL.
Detailed description
Weakness of the ankle plantarflexors after a stroke results in impaired forward propulsion during walking, which consequently impacts walking efficiency and speed - parameters that are necessary for community participation. Next-generation soft, wearable robots, known as soft robotic exosuits, were developed to assist paretic ankle dorsiflexion during its swing phase and paretic ankle plantarflexion during push off. Prior observational studies of the exosuit technology have culminated in strong evidence of immediate gait-restorative effects for patients post-stroke through improved forward propulsion, and faster and farther walking. The investigators posit that gait training using exosuits will leverage these immediate gait-restorative effects to facilitate gait training at higher intensities without compromising gait quality. This type of training will facilitate lasting rehabilitative effects that persist beyond the use of exosuit. Leveraging a systematic approach in the staging of pilot studies toward larger clinical trials, this clinical validation was initiated with a single-subject study design followed by a case series, which both provided early evidence for the potential of gait training with exosuits in restoring propulsion and speed. As a next step, the investigators seek to examine the efficacy of these interventions under more robust terms by implementing a randomized clinical trial (RCT).
The primary aim of the current study seeks to understand the rehabilitative effects of a Robotic Exosuit Augmented Locomotion (REAL) gait training program relative to matched gait training without exosuits (Control) on walking and propulsion function after stroke. It is hypothesized that REAL training will result in clinically meaningful improvements in walking speed that are greater than the speed gains following Control training. Further, this study seeks to examine whether training-related changes in propulsion function following both interventions (REAL, Control) influence the training-induced effects on walking function. The investigators hypothesize that REAL training will result in substantial gains in walking function that are achieved through improved propulsion function, while Control training will have modest gains in walking function that are not related to changes in propulsion.
A secondary aim of this study is to evaluate single day changes in neuromuscular control following both interventions (REAL, Control), as measured by muscle synergies and the dynamic motor control index. The investigators hypothesize that neuromuscular control will immediately improve during powered use of a soft-robotic exosuit (i.e., immediate) and exosuit-induced improvements in neuromuscular control will show continued improvement over a single session of REAL gait training (i.e., adaptation), and persisting improvement to unassisted walking after a single session of REAL gait training (i.e., retention). In contrast, the Control training will show no changes in neuromuscular control. An additional secondary aim is to identify neuromuscular predictors of training-related improvements in walking and propulsion function. It is hypothesized that positive relationships will be observed between single-day changes in neuromuscular control and training-induced improvements in walking and propulsion function after 12 sessions of gait training. Moreover, the investigators hypothesize that regardless of baseline walking speed, individuals with higher baseline neuromuscular control will have the greatest training-induced improvements in propulsion and walking function after 12 sessions of gait training.
For this protocol, exosuits developed in collaboration with an industry partner (ReWalk™ Robotics) will be used. To examine the effects of REAL gait training, the investigators will use clinical measures of motor and gait function, locomotor mechanics, and physiologic measures that may infer on motor learning. The spectrum of behavioral and physiologic data that will be collected will enable a more comprehensive understanding of the gait-restorative effects of REAL.
This study will be implemented by carrying out the following study visits: (1) Primary screen over the phone, (2) Clinical screen \& fit, (3) Exposure, (4) Pre-training evaluations, (5) Training (12 sessions)(6) Post-training evaluation, and (7) Retention evaluation. Randomization to either REAL or Control will occur after Pre-training evaluation. A washout period up to 4 weeks will precede Retention evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either intervention of (1) REAL, or (2) Control.
| Arm | Type | Receives |
|---|---|---|
| REAL training | Experimental | Device: Soft exosuitRobotic Exosuit Augmented Locomotion (REAL) refers to gait training with soft robotic exosuits, performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by the physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. REAL includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time. |
| Control training | Active comparator | Behavioral: Gait training without exosuitsControl training refers to similarly structured gait training as with REAL, with the only exception of using soft robotic exosuits. Control training is performed under a speed-based approach where participants are asked to walk at faster speeds in treadmill and overground environments. Cues and summary feedback emphasizing walking speed and forward propulsion are provided by physical therapist to facilitate goal-directed walking practice. Training is progressively challenging based on environmental complexity and practice variability. Control training includes 12 training sessions, administered 2-3x/week. Each session includes 30 minutes of total walking time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18 - 80 years old
- Stroke event occurred at least 6 months ago
- Observable gait deficits
- Gait speed equal to or less than 1 m/s
- Able to walk without the support of another person for at least 6 minutes (may use an assistive device as needed, but without use of an ankle foot orthosis or brace)
Key exclusion criteria (9 listed)
- Score of >1 on question 1b and >0 on question 1c on the NIH Stroke Scale
- Inability to communicate with investigators
- Neglect or hemianopia
- Actively receiving physical therapy for walking
- History of cerebellar strokes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soft exosuitA soft exosuit is a textile-based wearable robot that is worn on the paretic ankle. Soft exosuits provide assistive torques through retraction of Bowden cables that connect distally to anchor points on front and back of the ankle, assisting with dorsiflexion during swing for foot clearance, and plantarflexion during late stance to assist with propulsion, respectively. Exosuit assistance is provided synchronously based on the wearer's gait, as detected by integrated inertial measurement units. | Device | REAL training |
| Gait training without exosuitsControl intervention will implement gait training without exosuits. Other elements of intervention are similarly structured as with REAL, with the only exception of using exosuits. | Behavioural | Control training |
Primary outcome
6-Minute Walk Test (6MWT)
Time frame: Baseline (Pre-training Evaluation)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
6-Minute Walk Test (6MWT)
Time frame: Post-training Evaluation (up to 6 weeks)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
6-Minute Walk Test (6MWT)
Time frame: Retention Evaluation (up to 4 weeks post-washout)
This is test of long-distance walking function. The participant will be asked to "cover as much distance as they safely can" for 6 minutes, and total distance is the main metric from this test. This will be performed without wearing the soft exosuit (No Suit) regardless of intervention.
10-Meter Walk Test (10MWT)
Time frame: Baseline (Pre-training Evaluation)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
10-Meter Walk Test (10MWT)
Time frame: Post-training Evaluation (up to 6 weeks)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
10-Meter Walk Test (10MWT)
Time frame: Retention Evaluation (up to 4 weeks post-washout)
This is a test of short-distance walking function. The participant will be asked to walk at comfortable walking speed (CWS) and maximum walking speed (MWS) on a ten-meter straight walkway.
5 secondary outcomes
Forward propulsion
Time frame: Baseline (Pre-training Evaluation)
Forward propulsion
Time frame: Post-training Evaluation (up to 6 weeks)
Forward propulsion
Time frame: Retention Evaluation (up to 4 weeks post-washout)
Muscle Synergies
Time frame: Baseline (Pre-training Evaluation)
Dynamic Motor Control Index
Time frame: Baseline (Pre-training Evaluation)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- BackgroundAwad LN, Bae J, O'Donnell K, et al. Soft exosuits increase walking speed and distance after stroke. In: International Symposium on Wearable Robotics and Rehabilitation (WeRob). Houston, TX: IEEE; 2; 2017.
- Background: PubMed 28777105Awad LN, Bae J, Kudzia P, Long A, Hendron K, Holt KG, O'Donnell K, Ellis TD, Walsh CJ. Reducing Circumduction and Hip Hiking During Hemiparetic Walking Through Targeted Assistance of the Paretic Limb Using a Soft Robotic Exosuit. Am J Phys Med Rehabil. 2017 Oct;96(10 Suppl 1):S157-S164. doi: 10.1097/PHM.0000000000000800.
- Background: PubMed 28747517Awad LN, Bae J, O'Donnell K, De Rossi SMM, Hendron K, Sloot LH, Kudzia P, Allen S, Holt KG, Ellis TD, Walsh CJ. A soft robotic exosuit improves walking in patients after stroke. Sci Transl Med. 2017 Jul 26;9(400):eaai9084. doi: 10.1126/scitranslmed.aai9084.
- Background: PubMed 29361587Bae J, Awad LN, Long A, O'Donnell K, Hendron K, Holt KG, Ellis TD, Walsh CJ. Biomechanical mechanisms underlying exosuit-induced improvements in walking economy after stroke. J Exp Biol. 2018 Mar 7;221(Pt 5):jeb168815. doi: 10.1242/jeb.168815.
- Background: PubMed 30595090Ardestani MM, Kinnaird CR, Henderson CE, Hornby TG. Compensation or Recovery? Altered Kinetics and Neuromuscular Synergies Following High-Intensity Stepping Training Poststroke. Neurorehabil Neural Repair. 2019 Jan;33(1):47-58. doi: 10.1177/1545968318817825. Epub 2018 Dec 29.
- Background: PubMed 24515925Holleran CL, Straube DD, Kinnaird CR, Leddy AL, Hornby TG. Feasibility and potential efficacy of high-intensity stepping training in variable contexts in subacute and chronic stroke. Neurorehabil Neural Repair. 2014 Sep;28(7):643-51. doi: 10.1177/1545968314521001. Epub 2014 Feb 10.
- Background: PubMed 7762049Hesse S, Bertelt C, Jahnke MT, Schaffrin A, Baake P, Malezic M, Mauritz KH. Treadmill training with partial body weight support compared with physiotherapy in nonambulatory hemiparetic patients. Stroke. 1995 Jun;26(6):976-81. doi: 10.1161/01.str.26.6.976.
- Background: PubMed 12610841Paci M. Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies. J Rehabil Med. 2003 Jan;35(1):2-7. doi: 10.1080/16501970306106.
- Background: PubMed 31122660Ardestani MM, Henderson CE, Hornby TG. Improved walking function in laboratory does not guarantee increased community walking in stroke survivors: Potential role of gait biomechanics. J Biomech. 2019 Jun 25;91:151-159. doi: 10.1016/j.jbiomech.2019.05.011. Epub 2019 May 17.
- Background: PubMed 30408710Roelker SA, Bowden MG, Kautz SA, Neptune RR. Paretic propulsion as a measure of walking performance and functional motor recovery post-stroke: A review. Gait Posture. 2019 Feb;68:6-14. doi: 10.1016/j.gaitpost.2018.10.027. Epub 2018 Oct 25.
- Background: PubMed 16456121Bowden MG, Balasubramanian CK, Neptune RR, Kautz SA. Anterior-posterior ground reaction forces as a measure of paretic leg contribution in hemiparetic walking. Stroke. 2006 Mar;37(3):872-6. doi: 10.1161/01.STR.0000204063.75779.8d. Epub 2006 Feb 2.
- BackgroundBae J, Siviy C, Rouleau M, et al. A lightweight and efficient portable soft exosuit for paretic ankle assistance in walking after stroke. Proc - IEEE Int Conf Robot Autom. 2018:2820-2827. doi:10.1109/ICRA.2018.8461046
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lou Awad, PT, DPT, PhD principal investigator
Boston University Charles River Campus
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soft exosuit and Gait training without exosuits in people with Stroke, run by Lou Awad, PT, DPT, PhD at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (6MWT) (time frame: Baseline (Pre-training Evaluation)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04818424, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.