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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

Stroke is the leading cause of adult-onset disability, and affects 15,000 Veterans each year. Successful rehabilitation and recovery following a stroke requires therapy including repetitive task training. However, repetitive task training can be draining for both the clinician and the patient as it requires the participant to complete many repetitions of the same task and those repetitions can be difficult to accomplish with appropriate technique. Robot-mediated repetitive task training has the potential to facilitate the clinical delivery of proven rehabilitation programs to Veterans in need and recently a new exoskeleton has been developed, called Harmony, which can deliver bimanual 3D arm therapy. The investigators propose to develop and test two novel controllers', synergy avoidance and task assistance, that use promising neurological basis for training to facilitate repetitive task training while ensuring correct movement patterns in acute and sub-acute stage stroke patients. This has the potential to improve Veterans' activities of daily living and quality of life.

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 data supports the effectiveness of the Exoskeleton-Assisted Therapy for Stroke treatment?

Research shows that robotic exoskeletons can help improve movement and walking in stroke patients by providing necessary assistance while encouraging active participation. Studies have demonstrated improvements in motor control and daily activities, suggesting that exoskeletons can be a promising tool for stroke rehabilitation. ^{1 2 3 4 5}

Is exoskeleton-assisted therapy safe for humans?

Research shows that exoskeleton-assisted therapy is generally safe for humans, with no adverse effects reported in studies involving stroke survivors. Participants in these studies completed therapy sessions without any reported issues, indicating the treatment's safety in clinical settings. ^{2 6 7 8 9}

How does the Exoskeleton-Assisted Therapy for Stroke differ from other treatments for stroke recovery?

The Exoskeleton-Assisted Therapy for Stroke is unique because it uses a robotic exoskeleton to provide targeted assistance to patients, allowing them to perform movements with minimal help, which encourages active participation and potentially faster recovery. This approach contrasts with traditional therapies that may not offer the same level of personalized, adaptive support and motivation through interactive elements like virtual reality games. ^{1 4 5 10 11}

Research Team

Brittney C Muir, PhD

Principal Investigator

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

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]

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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Optimizing compliant, model-based robotic assistance to promote neurorehabilitation. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Powered robotic exoskeletons in post-stroke rehabilitation of gait: a scoping review. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary Assessment of a Postural Synergy-Based Exoskeleton for Post-Stroke Upper Limb Rehabilitation. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Hand function recovery in chronic stroke with HEXORR robotic training: A case series. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

An assistive control approach for a lower-limb exoskeleton to facilitate recovery of walking following stroke. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Exoskeleton-Assisted Sit-to-Stand Training Improves Lower-Limb Function Through Modifications of Muscle Synergies in Subacute Stroke Survivors. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Preliminary assessment of a lower-limb exoskeleton controller for guiding leg movement in overground walking. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Exploring the Capabilities of Harmony for Upper-Limb Stroke Therapy. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Low-Cost, Modular Muscle-Computer Interface for At-Home Telerehabilitation for Chronic Stroke. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Multi-Objective Optimization-Based Assist-as-Needed Controller for Improved Quality of Assistance in Rehabilitation Robotics. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

An Exoneuromusculoskeleton for Self-Help Upper Limb Rehabilitation After Stroke. [2022]