An Upper Extremity Exoskeleton to Target Unwanted Joint Synergies During Repetitive Training in Stroke Survivors

NCT05962697 | Withdrawn

• 2 other identifiers: A4631-PRZ004631
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Stroke

Keywords

Stroke; Exoskeleton; upper extremity; robot; rehabilitation; joint synergy; controller; feasibility

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Fugl-Meyer Upper Extremity (FM-UE) at 3 weeks

  Clinical measure of upper extremity function Range 0 to 66 - 0 is impaired, 66 is unimpaired

  3 weeks

• Change from Baseline Action Research Arm Test (ARAT) at 3 weeks

  Clinical measure of upper extremity function Range 0 to 57 0 is impaired, 57 is unimpaired

  3 weeks

Study Arms (2)

SA controller

EXPERIMENTAL

Synergy assistance controller

Other: SA controller; Other: TA controller

early testing

OTHER

up to 5 participants testing the SA controller in one visit

Other: SA controller early testing

Interventions

SA controller OTHER

Novel controller to be tested

Also known as: Synergy assistance

SA controller

TA controller OTHER

original controller to be tested

Also known as: Task assistance

SA controller

SA controller early testing OTHER

Novel controller to be tested early testing

Also known as: Synergy assistance early testing

early testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over the age of 18 years,
• have a Fugl-Meyer Upper Extremity score of 29-42 for moderately impaired (aim 1) or 0-28 for severely impaired (aim 1 and 2),
• have body dimensions within the limits of the Harmony system
• suffered a stroke within the past 1-6 months (aim 1) or 1 week (aim 2)

You may not qualify if:

• recurrent stroke,
• unstable cardiovascular, orthopedic, or neurological conditions,
• a history of seizure,
• significant communication deficits,
• severe upper-limb joint pain or limitations that would restrict their ability to complete the protocols,
• inadequate cognitive or language function to consent or to participate, and (7) no phone number or stable mailing address.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Brittney C Muir, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: July 27, 2023
• Study Start: August 3, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 12, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)