Robotic Exosuit Augmented Locomotion (REAL)

NCT04818424 | Withdrawn FDA Device

• 1 other identifier: 5520
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Stroke

Keywords

Exosuit; Soft Robotics; Wearable Robots; Gait Rehabilitation; Propulsion

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Retention Evaluation (up to 4 weeks post-washout)

Secondary Outcomes (5)

• Forward propulsion

  Baseline (Pre-training Evaluation)

• Forward propulsion

  Post-training Evaluation (up to 6 weeks)

• Forward propulsion

  Retention Evaluation (up to 4 weeks post-washout)

• Muscle Synergies

  Baseline (Pre-training Evaluation)

• Dynamic Motor Control Index

  Baseline (Pre-training Evaluation)

Study Arms (2)

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.

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.

Behavioral: Gait training without exosuits

Interventions

Soft exosuit DEVICE

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.

REAL training

Gait training without exosuits BEHAVIORAL

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.

Control training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Lou Awad, PT, DPT, PhD: lead
• Harvard University: collaborator
• Spaulding Rehabilitation Hospital: collaborator

Study Sites (3)

Harvard University

Boston, Massachusetts, 02134, United States

Location

Boston University

Boston, Massachusetts, 02215, United States

Location

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, 02129, United States

Location

Related Publications (16)

• 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.

  BACKGROUND

• 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.

  PMID: 28777105 BACKGROUND

• Awad 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.

  PMID: 28747517 BACKGROUND

• Bae 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.

  PMID: 29361587 BACKGROUND

• Ardestani 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.

  PMID: 30595090 BACKGROUND

• Holleran 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.

  PMID: 24515925 BACKGROUND

• Hesse 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.

  PMID: 7762049 BACKGROUND

• Paci 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.

  PMID: 12610841 BACKGROUND

• Ardestani 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.

  PMID: 31122660 BACKGROUND

• Roelker 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.

  PMID: 30408710 BACKGROUND

• Bowden 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.

  PMID: 16456121 BACKGROUND

• Bae 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

  BACKGROUND

• 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.

  PMID: 33748765 BACKGROUND

• Dobkin 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.

  PMID: 19240197 BACKGROUND

• Porciuncula 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.

  BACKGROUND

• Porciuncula F, Arumukhom Revi D, Baker TC, et al. Speed-Based Gait Training with Soft Robotic Exosuits Improves Walking after Stroke: A Crossover Pilot Study. In: American Physical Therapy Association Combined Sections Meeting. ; 2021.

  BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lou Awad, PT, DPT, PhD

  Boston University Charles River Campus

  PRINCIPAL INVESTIGATOR

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: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Physical Therapy

Model Details: Participants are randomly assigned to either intervention of (1) REAL, or (2) Control.

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 26, 2021
• Study Start: February 24, 2021
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)