Robotic Interventions for Spasticity Treatment

NCT05006248 | Suspended

• 1 other identifier: STU00213328
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Spasticity; Robotic Rehabilitation; Electromyography; Haptic Feedback; Visual Feedback

Outcome Measures

Primary Outcomes (11)

• Change in flexion/extension range of motion (ROM)

  To measure the flexion/extension ROM, the patient will be instructed to perform flexion and extension as much as possible. The patient will repeat this for a total of three trials and the average ROM across all three trials will be recorded. A larger value compared to baseline indicates improvement in ROM.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in maximal volitional electromyographic activity

  Maximal volitional electromyographic activity (MVEA) is muscle activity recorded while the participant is contracting the muscle of interest as strongly as possible while seated. A higher value compared to baseline indicates improvement.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in Maximum Voluntary Contraction Torque (MVCT)

  To measure MVCT, the patient will be instructed to perform ankle flexion and extension as strongly as possible for three seconds while seated and wearing the M1 device. This will be completed on both legs A larger value compared to baseline is usually a better outcome.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in manual muscle test

  Physical function test measuring strength of the muscle of interest. A muscle is isolated, and gradual external force is applied at a right angle to the muscle's long axis. Each muscle is scored on a graded scale of "weak" (score of 0) to "strong" (score of 5) based on the participant's ability to resist the external force. The test is first completed for muscles on the unimpaired side to determine normal strength before being repeated on the impaired side. Weaker participants may be tested while lying prone (gravity eliminated). A higher score value indicates higher strength and improvement.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in Modified Ashworth Scale

  Physical function test measuring spasticity on a 6-point ordinal scale. A score of 0 on the scale indicates no increase in tone while a score of 4 indicates rigidity. Tone is scored by passively moving the individual's limb and assessing the amount of resistance to movement felt by the examiner. A lower score is a better outcome.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in 10-meter walking test

  Physical function test measuring the total time to ambulate 10 meters in order to calculate walking speed in meters per second. A shorter time indicates a better walking speed.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in 6-minute walking test

  Physical function test measuring the total distance walked in a span of six minutes will be assessed. A longer distance indicates a better walking distance.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in balance with functional gait assessment

  Change in balance during dynamic walking activities will be assessed using the functional gait assessment (FGA). A higher score indicates better balance and decreased fall risk.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in balance with the Berg balance scale

  Change in static and dynamic sitting and standing balance will be assessed using the Berg balance scale. Items are scored from zero to four. A higher score indicates better balance and decreased fall risk.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in ankle maximum strength via dynamometer testing

  Change in strength will be assessed via the maximum voluntary contraction for joints with a dynamometer. A larger value compared to baseline indicates improvement in strength.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

• Change in Functional Gait Assessment (FGA)

  The FGA is a 10-item test for assessing postural stability during various walking tasks. Each item is scored on an ordinal scale from 0 to 3. Items include "gait with narrow base of support", "ambulating backwards", and "gait with eyes closed". Individuals are allowed to perform the assessment with an assistive device and necessary bracing. Research personnel will provide supervision and assist as needed for each task. A higher score usually indicates a better outcome.

  Baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks), 1 month after completing all training sessions, and 3 months after completing all training sessions.

Secondary Outcomes (1)

• Change in co-activation index of the muscles

  Each training session/visit and through study completion, (12 visits).

Study Arms (3)

Conventional robotic continuous passive movement training

ACTIVE COMPARATOR

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.

Device: Conventional robotic continuous passive movement training

Visual Feedback

EXPERIMENTAL

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. 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: Visual Feedback

Haptic and Visual Feedback

EXPERIMENTAL

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. The assistance mode of the robotic device applies assistive/resistive torque based on muscle activity.

Device: Haptic and Visual Feedback

Interventions

Conventional robotic continuous passive movement training DEVICE

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.

Conventional robotic continuous passive movement training

Visual Feedback DEVICE

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.

Visual Feedback

Haptic and Visual Feedback DEVICE

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.

Haptic and Visual Feedback

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, inclusive
• Normal hearing and vision, can be corrected
• Participants must have muscle sites appropriate for biofeedback (see below)
• Participants must have a minimum active flexion angle of 15 degrees and a minimum extension angle of 10 degrees.
• No skin allergies to adhesive material or paste
• No neurological disorders
• Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, chronic pain, musculoskeletal injuries)
• Able to understand and give informed consent
• years of age, inclusive
• Normal hearing and vision, can be corrected
• Participants must have muscles sites appropriate for biofeedback (see below)
• No skin allergies to adhesive material or paste
• Unilateral, supratentorial ischemic or hemorrhagic stroke ≥ three months prior
• Participants must have a minimum activation against gravity for dorsiflexion and plantar flexion, equivalent to a Manual Muscle Test (MMT) score of greater than or equal to +2
• Ability to walk \>10m independently on level ground, allowed to use assistive devices or bracing as needed

You may not qualify if:

• Comorbid traumatic brain injury
• Premorbid cognitive limitations that would prevent playing games
• Adults unable to consent, pregnant women, children, or prisoners
• Implantable pacemaker, spinal stimulator, or vagal nerve stimulator
• Known skin allergies to silver
• The overlying skin on recording areas has any infection, wounds, or graft sites
• Potential biofeedback muscles do not have detectable electromyographic activity (this will be tested after subjects are consented and enrolled)
• History of sustained non-prescribed drug use (as reported by subject) or substance abuse (exception: current nicotine use is allowed)
• Prior neurosurgical procedures
• History of peripheral nerve injury
• Severe hip, knee, or ankle arthritis
• Recent fracture or osteoporosis (as reported by subject)
• Medical (cardiac, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
• Inability or unwillingness to perform study-required activities
• Comorbid traumatic brain injury

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jose L Pons, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The purpose of this study 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.

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: August 16, 2021
• Study Start: March 27, 2022
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: August 2, 2024

Record last verified: 2024-08

Locations

US (1)