Effects of Vibration on Motor Function of Survivors of Chronic Stroke

NCT06663501 | Active Not Recruiting FDA Device

• 1 other identifier: STU00219884
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate how vibration of the tendons enhances arm and hand training in survivors of chronic stroke. The investigators hypothesize that wrist/elbow robotic training, combined with body awareness training will improve arm and hand function in individuals with chronic stroke.

Conditions

Stroke; Healthy

Keywords

Upper extremity; AMES; Proprioception; Vibration

Outcome Measures

Primary Outcomes (1)

• Change in Fugl-Meyer Assessment for the upper extremity score

  The Fugl-Meyer Assessment for the upper extremity measures the severity of injury following a stroke. The assessment is scored from 0-66 points. A higher score indicates less impairment

  1 day following intervention

Secondary Outcomes (3)

• Proprioception Assessment

  1 day following intervention

• Modified Ashworth Score

  1 day following intervention

• Strength Assessment

  1 day following intervention

Study Arms (2)

Stroke Intervention

EXPERIMENTAL

In this arm, the participant will be scheduled to come to the laboratory 2-4 times per week and spend 30 minutes using the Assisted Motion with Enhanced Sensation (AMES) treatment device on the affected side of the upper limb.

Device: Assisted Motion with Enhanced Sensation training

Uninjured Control Intervention

ACTIVE COMPARATOR

In this arm the uninjured controls will perform the same interventions as the stroke group. The uninjured control group will perform the tests and interventions with their dominant arm/hand.

Device: Assisted Motion with Enhanced Sensation training

Interventions

Assisted Motion with Enhanced Sensation training DEVICE

During the AMES intervention, the AMES device will flex or extend the wrist/hand joint, and the participant's task will be to assist this motion. As the wrist/hand joint moves, the machine will be delivering a vibratory mechanical stimulus on the opposite side to the direction of movement. The activity of the muscles during the movement of the wrist/hand joint will be recorded by the device and it will be shown on a screen to be used as feedback during the training

Also known as: AMES Training

Stroke Intervention; Uninjured Control Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• If stroke, more than 6 months after
• Medically stable
• Not currently taking any anti-spasticity medications (for at least 2 weeks)
• Able to comply with study requirements

You may not qualify if:

• Recent change in the use of any medications
• Other physical conditions such as orthopedic injuries or surgeries
• Unstable Medical conditions or any other clinical observations that may affect the candidates performance, health, safety, or ability to participate in the study as determined by the treating therapist
• Anti-spasticity drug injection in the 3 months prior to participation
• Presence of significant cardiorespiratory or metabolic disease
• Inability to achieve standard position required for EMG recordings
• Intrathecal baclofen pump
• Musculoskeletal conditions/surgeries resulting in difficulty participating
• Adults unable to consent
• Pregnant women, prisoners, and individuals under the age of 18

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, 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

• William Z Rymer, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Single Motor Unit Laboratory

Model Details: Single-site exploratory, unrandomized, the first arm is persons with stroke, the second arm is uninjured controls. Both Cohorts receive the same intervention

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)