Exoskeleton-Assisted Therapy for Stroke

Overseen By Brittney C Muir, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Recurrent stroke, Seizure, Communication deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic therapy tool called Harmony, designed to assist stroke survivors with arm movements. The goal is to make rehabilitation easier and more effective by using two special techniques: the SA controller (Synergy Avoidance controller) and the TA controller (Task Assistance controller), which ensure proper movement patterns. The trial targets individuals who experienced a stroke within the past one to six months and have moderate to severe arm impairment. Harmony could potentially improve daily activities and quality of life for participants.

As an unphased trial, this study offers a unique opportunity to contribute to innovative rehabilitation research that could enhance recovery for future stroke survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Harmony exoskeleton is safe for stroke rehabilitation?

Research shows that exoskeleton devices, like the Harmony used in this trial, are generally safe and well-tolerated for people recovering from a stroke. Studies on similar robotic devices have demonstrated improvements in walking speed, endurance, and balance for stroke patients. This suggests that these devices can be safely included in rehabilitation programs.

The Harmony exoskeleton, used with the Synergy Avoidance (SA) controller being tested, is designed to guide correct arm movements and prevent abnormal patterns that can occur after a stroke. Although specific safety data for the SA controller is not yet available, research on similar technology suggests it is safe.

In summary, while direct safety data for the SA controller is limited, the underlying technology has proven safe and helpful in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exoskeleton-assisted therapy for stroke because it introduces a new way to aid recovery by using robotic technology. Unlike traditional physical therapy, which relies on manual guidance and exercises, this therapy uses an exoskeleton equipped with a synergy assistance (SA) controller. This controller offers precise support by adjusting to the patient’s movements in real-time, potentially enhancing motor learning and recovery. By integrating advanced robotics, the therapy aims to offer more personalized and effective rehabilitation, potentially speeding up recovery and improving outcomes for stroke survivors.

What evidence suggests that this exoskeleton-assisted therapy is effective for stroke rehabilitation?

Studies have shown that the Harmony exoskeleton, which uses a special controller called Synergy Avoidance (SA), can aid in stroke recovery. In this trial, participants will test the SA controller, which stops abnormal movements and encourages normal, healthy ones. This process helps patients practice tasks correctly, crucial for recovery after a stroke. Research indicates that robotic exoskeletons like the Harmony support joint movement and overall physical recovery. As a result, the exoskeleton could help patients regain their ability to perform daily activities after a stroke. ^{1 3 4 5 6}

Who Is on the Research Team?

Brittney C Muir, PhD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

This trial is for stroke survivors over 18 who fit within the Harmony exoskeleton's size limits. Participants should have moderate to severe upper limb impairment, as measured by a specific score, and must have had their stroke recently (1 week to 6 months prior). Those with unstable health conditions, severe joint pain in the limbs, cognitive or language barriers, multiple strokes, seizures or significant communication issues cannot join.

Inclusion Criteria

You need to have body measurements that fit within the Harmony system's limits.

I had a stroke between 1 week and 6 months ago.

My arm and hand movement is moderately to severely limited.

Exclusion Criteria

You have trouble communicating effectively.

I have had more than one stroke.

I do not have unstable heart, bone, or nerve conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Early Testing

Up to 5 participants testing the SA controller in one visit

1 day

1 visit (in-person)

Treatment

Participants complete high repetitions of reaching tasks once per day while wearing the Harmony exoskeleton for three weeks

3 weeks

Daily sessions

Follow-up

Participants are monitored for changes in joint coordination and compensatory strategies after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SA controller
• TA controller

Trial Overview The study is testing two new control systems for an arm therapy exoskeleton called Harmony. These systems are designed to help patients perform repetitive tasks correctly during rehabilitation after a stroke. The goal is to see if these controllers can improve daily living activities and quality of life for Veterans.

How Is the Trial Designed?

Group I: early testing Experimental Treatment 1 Intervention

up to 5 participants testing the SA controller in one visit

Group II: SA controller Experimental Treatment 2 Interventions

Synergy assistance controller

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

The developed controller for a powered lower-limb exoskeleton is designed to assist gait training for individuals with post-stroke hemiparesis by reshaping leg movement during walking, specifically during the swing phase.

Preliminary tests on a healthy subject showed that the controller effectively coordinated movement while allowing for necessary step-to-step variability, indicating potential for safe and effective rehabilitation support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary assessment of a lower-limb exoskeleton controller for guiding leg movement in overground walking. Martinez, A., Lawson, B., Goldfarb, M.[2018]

Powered robotic exoskeletons are a safe intervention for gait rehabilitation in stroke patients, showing meaningful improvements in walking outcomes, especially in those who are in the sub-acute phase of recovery.

While exoskeleton training is equivalent to traditional therapy for chronic stroke patients, sub-acute patients may benefit more from this technology, indicating a need for further rigorous trials to establish its clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. Louie, DR., Eng, JJ.[2023]

The Hand Exoskeleton Rehabilitation Robot (HEXORR) therapy showed promising results in improving active finger and thumb range of motion in four chronic stroke patients after 18 sessions, indicating its potential effectiveness in rehabilitation.

The therapy was well-received by participants and is particularly beneficial for patients with mild to moderate spasticity, suggesting it can assist in overcoming resistance to hand extension post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand function recovery in chronic stroke with HEXORR robotic training: A case series. Godfrey, SB., Schabowsky, CN., Holley, RJ., et al.[2020]

The Tele-REINVENT system, a low-cost telerehabilitation biofeedback tool, has been developed to help stroke survivors improve muscle control at home, showing feasibility and safety in a case study with one stroke patient over 40 sessions in 10 weeks.

Preliminary results indicate that the system can effectively train differentiated muscle activity and reduce unwanted co-contractions, suggesting it could be a valuable tool for personalized rehabilitation in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Low-Cost, Modular Muscle-Computer Interface for At-Home Telerehabilitation for Chronic Stroke. Marin-Pardo, O., Phanord, C., Donnelly, MR., et al.[2021]

The novel EMG-driven exoneuromusculoskeleton significantly improved upper limb performance in stroke patients, enhancing joint extension and voluntary motor function during self-help training, as shown in a pilot trial with 15 participants after 20 sessions (p < 0.05).

The system effectively combined neuromuscular electrical stimulation and mechanical assistance, leading to reduced muscle spasticity and improved muscular coordination, demonstrating its potential for upper limb rehabilitation post-stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. Nam, C., Rong, W., Li, W., et al.[2022]

The Armule exoskeleton, designed with a postural synergy concept, significantly improved motor control and activities of daily living in eight participants with hemiplegia after four weeks of therapy, as measured by the Fugl-Meyer Assessment and other clinical tests.

Participants showed notable improvements in both clinical measures (e.g., FMA-UE increased by 11.50 points) and kinematic metrics, suggesting that the exoskeleton's design effectively supports natural movement patterns during rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Assessment of a Postural Synergy-Based Exoskeleton for Post-Stroke Upper Limb Rehabilitation. He, C., Xiong, CH., Chen, ZJ., et al.[2021]

The study introduces a novel control approach for a lower-limb exoskeleton designed to help individuals with lower-extremity hemiparesis after a stroke, allowing patients to coordinate their own movements while receiving assistance.

In preliminary tests with three stroke patients, the exoskeleton significantly improved gait outcomes in each session, suggesting that this assistive controller effectively supports recovery in walking without dictating movement patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An assistive control approach for a lower-limb exoskeleton to facilitate recovery of walking following stroke. Murray, SA., Ha, KH., Hartigan, C., et al.[2022]

The Harmony exoskeleton was tested with five stroke survivors over seven hours of therapy, allowing them to perform 1130 motions without any reported adverse effects, indicating its safety for clinical use.

The device not only assists in rehabilitation but also helps therapists assess motor function and develop personalized therapy plans, showing promise for improving upper-limb coordination and function in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Capabilities of Harmony for Upper-Limb Stroke Therapy. Oliveira, AC., Rose, CG., Warburton, K., et al.[2020]

A novel adaptive controller for robot-aided movement training after stroke was developed, featuring high mechanical compliance and the ability to provide only the necessary assistance to patients, enhancing their engagement in therapy.

Tests with the Pneu-WREX robotic device showed that the 'assist-as-needed' approach improved patient participation and demonstrated the natural tendency of patients to rely on the robot for support when they could, which helps in motor learning and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing compliant, model-based robotic assistance to promote neurorehabilitation. Wolbrecht, ET., Chan, V., Reinkensmeyer, DJ., et al.[2022]

The proposed multi-objective optimization (MOO) controller for rehabilitation robotics enhances patient assistance by implementing both linear and non-linear constraints, including vibration constraints to help reduce tremors in patients.

In simulations, the MOO controller demonstrated similar performance to existing methods while providing improved quality of assistance by managing velocity and tremor, which is crucial for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multi-Objective Optimization-Based Assist-as-Needed Controller for Improved Quality of Assistance in Rehabilitation Robotics. Widanage, KND., Sheng, Z., Chen, HL., et al.[2023]

A study involving 10 healthy adults and 10 stroke participants identified abnormal muscle synergies in stroke survivors during sit-to-stand transitions, which are linked to reduced lower-limb function.

After a 3-week exoskeleton-assisted training with 7 stroke survivors, there was a notable improvement in muscle synergies and clinical scores, indicating that exoskeleton training can enhance lower-limb function by promoting more normal muscle coordination patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exoskeleton-Assisted Sit-to-Stand Training Improves Lower-Limb Function Through Modifications of Muscle Synergies in Subacute Stroke Survivors. Li, YA., Chen, ZJ., He, C., et al.[2023]

Citations

1. reneu.robotics.utexas.edu reneu.robotics.utexas.edu/projects/synergy-avoidance-controller-stroke-rehabilitation-harmony

Synergy Avoidance Controller for Stroke Rehabilitation with ... In our approach, we have developed a controller for the Harmony exoskeleton that deters abnormal synergy patterns and rewards normative movement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4249450/

Robotic Exoskeletons: A Perspective for the Rehabilitation ... The aim of the present text is to analyze the potential of robotic exoskeletons to specifically rehabilitate joint motion and particularly inter-joint ...

3. mdpi.com mdpi.com/2076-0825/14/3/108

Advances in Control Techniques for Rehabilitation ... This systematic review explores recent advances in control techniques for rehabilitation exoskeletons, focusing on their role in enhancing the physical recovery ...

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01680-2

Exploratory development of human–machine interaction ... An upper-limb exoskeleton hardware device named UarDus is constructed, along with three HMI modalities, offering both passive and active rehabilitation ...

5. frontiersin.org frontiersin.org/journals/neurorobotics/articles/10.3389/fnbot.2023.1186175/full

Review of adaptive control for stroke lower limb ... This review introduces traditional rehabilitation assessment methods, explores the possibility of lower limb exoskeleton robots combining sensors and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11287981/

Safety & efficacy of a robotic hip exoskeleton on outpatient ... Gait training with the GEMS-H exoskeleton showed significant improvements in walking speed, walking endurance, and balance in persons with chronic stroke.