Robotic Interventions for Spasticity Treatment

Summary

The researchers have developed games controlled by electromyographic (EMG) and inertial measurement unit (IMU) activity recorded by a sensor. These will provide biofeedback to participants post-stroke about the activity of their paretic muscles. The researchers anticipate that providing visual biofeedback will allow subjects to observe the level of co-activation in an agonist-antagonist muscle pair, and therefore initiate interventions to reduce their level of co-activation. Similarly, the researchers will provide additional haptic feedback using an assistive robot at the ankle joint (i.e., M1) and compare the results with the pure visual feedback condition. At the end, the main objective is to compare 1) conventional robotic continuous passive movement (CPM) training to 2) training with visual biofeedback and 3) training with both visual and haptic biofeedback.

Conditions

• Stroke
• Spasticity, Muscle

Interventions

DEVICE

Conventional robotic continuous passive movement training

The participants will be single-blinded and wear the M1 robotic device on their affected/weaker foot, and complete up to 30 minutes of continuous passive movement per training session. The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session.

DEVICE

Visual Feedback

The participants will be single-blinded and wear the M1 robotic device in transparency mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session. The transparency mode of the robotic device compensates for its weight and friction so that the participant does not feel weight while moving the device.

DEVICE

Haptic and Visual Feedback

The participants will be single-blinded and wear the M1 robotic device in assistance mode on their affected/weaker foot, and complete up to 30 minutes of training with visual biofeedback (games). The participants will complete 12 training sessions. Clinical assessments will be performed at baseline, immediately before the 6th training session, and immediately after the 12th training session. The assistance mode of the robotic device applies assistive/resistive torque based on muscle activity.

Sponsors & Collaborators

• Shirley Ryan AbilityLab

  lead OTHER

Principal Investigators

• Jose L Pons, PhD · Shirley Ryan AbilityLab

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-27

Primary Completion

2026-01-31

Completion

2027-01-31

Countries

• United States

Study Locations