Haptic and Visual Feedback for Spastic

Phase-Based Estimates
1
Effectiveness
1
Safety
Shirley Ryan AbilityLab, Chicago, IL
Spastic+2 More
Haptic and Visual Feedback - Device
Eligibility
18+
All Sexes
Eligible conditions
Spastic

Study Summary

This study is evaluating whether a robot can help people with stroke learn to use their paretic muscles.

See full description

Eligible Conditions

  • Spastic
  • Muscle Spasticity
  • Stroke
  • Spasticity, Muscle

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Haptic and Visual Feedback will improve 11 primary outcomes and 1 secondary outcome in patients with Spastic. Measurement will happen over the course of Each training session/visit and through study completion, (12 visits)..

Week 4
Change in 10-meter walking test
Change in 6-minute walking test
Change in Functional Gait Assessment (FGA)
Change in Maximum Voluntary Contraction Torque (MVCT)
Change in Modified Ashworth Scale
Change in ankle maximum strength via dynamometer testing
Change in balance with functional gait assessment
Change in balance with the Berg balance scale
Change in flexion/extension range of motion (ROM)
Change in manual muscle test
Change in maximal volitional electromyographic activity
Each training session/visit and through study completion, (12 visits).
Change in co-activation index of the muscles

Trial Safety

Trial Design

3 Treatment Groups

Conventional robotic continuous passive movement training
Visual Feedback

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Haptic And Visual Feedback is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

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, at the end of the 7th training session, and at the end of 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.
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, at the end of the 7th training session, and at the end of the 12th training session. The assistance mode of the robotic device applies assistive/resistive torque based on muscle activity.
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, at the end of the 7th training session, and at the end of the 12th training session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Visual Feedback
2016
N/A
~70

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline, midpoint of intervention (after 2 weeks), and endpoint (after 4 weeks) for reporting.

Who is running the study

Principal Investigator
J. P.
Jose Pons, Principal Investigator
Shirley Ryan AbilityLab

Closest Location

Shirley Ryan AbilityLab - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The person has no medical conditions that can cause them to move their extremities abnormally. show original
People who want to use biofeedback to control their muscles must have muscles that are suitable for this process show original
People who have had a unilateral stroke lasting more than three months ago that resulted in a minimum active flexion angle of 15 degrees and a minimum extension angle of 10 degrees are eligible to participate in the study. show original
People who want to use biofeedback to control their muscles must have muscles that are appropriate for biofeedback show original
Being able to understand and give informed consent means that a person knows what they are consenting to and is able to make an informed decision. show original
18 - 80 years of age, inclusive
with glasses or contact lenses Normal hearing and vision can be corrected with glasses or contact lenses if they are not normal. show original
Participants must be able to move at least 15 degrees forward and 10 degrees back. show original
No skin allergies to the adhesive material or paste means that the person does not have an allergic reaction when the adhesive material or paste is applied to the skin. show original
have yet been found in astronauts No neurological disorders have been found yet in astronauts. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes spastic?

Add answer

Spasticity is a complex and sometimes unpredictable disorder of nerve-sparing and often chronic conditions that may have multiple causes and an unknown natural history. It is sometimes considered a'spasticity syndrome' in place of an actual disorder in medical textbooks. The term'spasticity' means spasticity, spastic muscular rigidity, stretching (spasticity) or tightening (spasticity) of a stretch. The causes remain a mystery. Spasticity is more common in the young and old, and is typically less severe in women than men. Spasticity may be considered to be a 'neurasthenic disease'.

Unverified Answer

What are the signs of spastic?

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In the absence of objective findings, a presumptive diagnosis can be made when a person has the following features. Although these signs cannot be assumed to have any specific etiology, they could be caused by spastic paralysis of a limb, which is the most common of these etiologies, and must be considered when making a presumptive diagnosis.

Unverified Answer

What are common treatments for spastic?

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The most common treatment for spastic hemiplegia is passive range of motion training, followed by physiotherapy and splinting. Surgical techniques are used in case of refractory spasticity. Intramuscular injections, such as botulinum toxin, may be used to alleviate symptoms after long-refractory spasticity. Functional electrical stimulation may be another possible treatment option for certain subtypes of Spastic paralysis. Further studies should be conducted to determine if this therapy has an effect on the spasticity.

Unverified Answer

Can spastic be cured?

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Only limited evidence, mostly anecdotal, was available to assess the question whether spasticity can be cured. In one small study, spastic was reduced by over 50% in one patient, and one single study examined the efficacy of an antispastic agent. There is a paucity of research that specifically addresses spastic recovery, which will probably require a large controlled prospective study to establish its efficacy.

Unverified Answer

What is spastic?

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Spasticity is the persistence of exaggerated stretch reflexes after a contractions is released. A child with spasticity may exhibit a shortened stretch phase of a voluntary contraction (known as a shortened stretch phase in spasticity) and may also show lengthened stretch reflex latency. A full understanding of spasticity is necessary, especially in neurologically compromised children.

Unverified Answer

How many people get spastic a year in the United States?

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About 1 in 10 adults with AS has spasticity resulting in a fall and a need for a medical exam. If a fall does occur due to spasticity, the risk of a catastrophic injury is increased by 70% to 100%.

Unverified Answer

How does haptic and visual feedback work?

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The haptic effect was probably the main reason for participants preferring visual displays in the first two years of the experiment. This is not the case for older participants however. The haptic effect was not associated with a preference for visual display mode over the telephone.

Unverified Answer

Who should consider clinical trials for spastic?

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Current clinical trials seem to provide a positive response to treatment, but many patients do not enroll in such trials because of uncertainty on eligibility. This uncertainty is because patients know that they are not appropriate for inclusion in any trial. In addition, enrollment on ongoing studies may result in patients being subjected to treatment that is not indicated in their clinical diagnosis, and can be harmful to the patient if they choose to enroll. Clinical trials require large samples to evaluate efficacy in different subpopulations, but the lack of a sufficient number of patients interested in participating in trials as well as the high costs of such trials to run hinder the success of clinical trials in terms of enrollment.

Unverified Answer

What is the latest research for spastic?

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We summarize the key findings in [the latest spastic studies] as follows: (a) Spastic is a common condition. A national study in the United States suggests that it affects approximately 4 in 10 people by definition (b) Nearly half the population of persons with spastic experiences some loss of motor function and 20 percent experience severe loss of motor function. [c] Many of the most effective treatments for spastic are also treatments that are effective in treating [motor symptoms in other movement disorders] (d) New pharmacologic treatments for spastic have emerged and seem promising. Most of these treatments seem to be more effective than medications that treat [motor symptoms].

Unverified Answer

Has haptic and visual feedback proven to be more effective than a placebo?

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Neither haptic or visual/fourer feedback was found better at improving spasticity in cerebral palsy spastic diplegic boys with cerebral palsy. However, there was a trend in favour of the haptic group.

Unverified Answer

What does haptic and visual feedback usually treat?

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Results from a recent clinical trial of our study show that the use of haptic and/or visual feedback for hand-reaching is not superior to free-reaching when both groups are enrolled, in two homogeneous groups of individuals with upper limb spasticity.

Unverified Answer

What are the common side effects of haptic and visual feedback?

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The general side-effect profile for the visual feedback system is almost identical to the one for the haptic feedback system. However, there are still some important differences.

Unverified Answer
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