CLINICAL TRIAL

Neuromechanical Gait Assist for Paresis

Recruiting · 18+ · All Sexes · Cleveland, OH

Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke

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About the trial for Paresis

Eligible Conditions
Stroke · Paresis · Hemiparesis

Treatment Groups

This trial involves 2 different treatments. Neuromechanical Gait Assist is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Neuromechanical Gait Assist
DEVICE
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Can use a cane for support. show original
The text defines stiff-legged gait as a way of walking that involves dragging or catching the toes during the swinging phase of the gait, or using compensatory strategies such as circumducting the affected limb, vaulting with the unaffected limb, or hiking the affected hip. show original
It has been more than six months since the stroke occurred. show original
The person can walk 10ft continuously with standby assistance. show original
The text states that there is a weakness at the hip, knee, and ankle. show original
One possible cause of poor lower extremity coordination is weakness or tone. show original
Hip extension range is the distance from the hip joint to the neutral position. show original
The hip joint has a range of motion of at least 90 degrees. show original
The passive range of ankle dorsiflexion is the distance a person can move their ankle while their knee is extended. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: up to one year after baseline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to one year after baseline
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: up to one year after baseline.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Neuromechanical Gait Assist will improve 1 primary outcome and 12 secondary outcomes in patients with Paresis. Measurement will happen over the course of up to one year after baseline.

Timed up and go test
UP TO ONE YEAR AFTER BASELINE
This test of agility measures the time required to stand, walk a set distance, turn around, walk back, and sit down again.
UP TO ONE YEAR AFTER BASELINE
Quantitative motion analysis - kinetics
UP TO ONE YEAR AFTER BASELINE
Participants complete mobility tasks in the laboratory (walking, stair ascent and descent, and sit-to-stand transitions). Body-worn and floor mounted sensors measure kinetics (i.e. joint torques).
UP TO ONE YEAR AFTER BASELINE
Controller accuracy
UP TO ONE YEAR
The accuracy of the controller (True/False positives and negatives) in detecting gait events and gait transitions.
UP TO ONE YEAR
10m walk test
UP TO ONE YEAR AFTER BASELINE
The time required to walk 10m is measured to calculate walking speed.
UP TO ONE YEAR AFTER BASELINE
Modified Ashworth scale
UP TO ONE YEAR AFTER BASELINE
This test measures spasticity. The joint is passively moved through its range of motion to determine muscle tightness in response to stretch. Scores range from 0 to 5. 0 is no increase in muscle tone while 5 indicates the joint is rigid.
UP TO ONE YEAR AFTER BASELINE
Quantitative motion analysis - kinematics
UP TO ONE YEAR AFTER BASELINE
Participants complete mobility tasks in the laboratory (walking, stair ascent and descent, and sit-to-stand transitions). Body-worn and floor mounted sensors measure kinematics (i.e. motion).
UP TO ONE YEAR AFTER BASELINE
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Patient Q & A Section

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

Can paresis be cured?

Paralysis of the upper limbs may be irreversible in some patients and its treatment may not be possible. In contrast, the lower limbs may be able to be reanimated by alternative means, which is why limb prosthesis should not be considered a definitive therapeutic response.

Anonymous Patient Answer

What are the signs of paresis?

Paresis involves weakness of the extremities, leading to slowness in movement and a weak or absent gait. The face often shows expressions of fear, and there may be decreased ability to speak.\n

Anonymous Patient Answer

What is paresis?

Paresis, also in the form of paraparesis or paraplegia, refers to partial or total paralysis of the limbs due to injury to the spinal cord. It results from a traumatic or medical condition.\n

Anonymous Patient Answer

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

This is the first time that a specific disorder has been identified that is common to two or more different disability groups in the US. The findings suggest a high prevalence of paresis and the need for better evaluation and management of this condition in the US.

Anonymous Patient Answer

What causes paresis?

There are multiple possible causes for paresis. Doctors have tried different treatments to try to cure paresis, but nothing has made a long-term recovery. Many people with paresis find their balance impaired after surgery. Some people may find it more challenging to cope with their disability and may resort to the use of drugs for mood instability (including depression and anxiety), which worsen the problem. To help patients have a more peaceful living style, help them find a more comfortable paretics' chair at their residence and help them live their life comfortably. Most of the time doctors and patients try to understand each other and find a way to help each other to live their life to the optimal.

Anonymous Patient Answer

What are common treatments for paresis?

As there are no specific guidelines for the treatment of paresis, it is impossible to recommend a treatment approach that is optimal for every person. However, in principle, any of the medications mentioned may be prescribed. In practice, medications are more often prescribed first and then are supplemented with additional therapies such as behavioural or cognitive therapy. Corticosteroids are also sometimes prescribed, especially in neurologically severe cases. In children and adolescents, surgery to modify muscle spindles or to perform corrective exercises has traditionally been the modality of choice. In most cases, surgery is avoided and surgery is a last resort solution. Corticosteroids in combination with other medications are most commonly recommended in children because they appear to reduce side effects.

Anonymous Patient Answer

Does neuromechanical gait assist improve quality of life for those with paresis?

Those with spasticity or paresis have difficulty maintaining weight-bearing on hard surfaces due to a shorter step length. The use of the neuromechanical gait-assisted treadmill provides greater weight-bearing on hard surfaces than walking in an uncontrolled environment. Using the neuromechanical treadmill significantly improves the quality of life, particularly for those with paresis.

Anonymous Patient Answer

What is the average age someone gets paresis?

Paresis occurs at a rate of approximately 30% each decade after age 60. The majority of patients present with symptoms for many years before diagnosis. The younger patients tend to have acute symptoms; the older patients have more severe late symptoms.

Anonymous Patient Answer

Is neuromechanical gait assist typically used in combination with any other treatments?

The present study showed the efficacy of NMG in the management of patients with a functional deficit in the lower limbs, whose functional capacity or who were physically active at home and in everyday activities is affected. The combination of conventional treatments and NMG appears to be effective in improving gait gait speed.

Anonymous Patient Answer

Have there been any new discoveries for treating paresis?

Today we treat paresis with corticosteroids, stimulant drugs and anticonvulsants. But we had not seen any new discoveries for treating paresis until recent years. One new discovery is the administration of neurogenic hormones. Neurogenic hormones are hormones that regulate the normal functionality of the nervous system. This article describes the history of the administration of neurogenic hormones and the latest research findings. Neurogenic hormones may be a good candidate to treat paresis because they may help to regenerate axons and may help to relieve symptoms. Further clinical trials will be needed before neurogenic hormones are considered reliable therapy for paresis.

Anonymous Patient Answer

How does neuromechanical gait assist work?

PGA improves the ability of older adults with peripheral neuropathy to resist force while walking at the prescribed speed. PGA may therefore be a useful exercise for limiting muscle fatigue in older adults with neuropathic pain.

Anonymous Patient Answer

What does neuromechanical gait assist usually treat?

During walking or swing phase, ankle plantarflexor strength is not correlated with self-selected walking speed. Ankle plantarflexor strength is not the only measure that could assist recovery from ankle plantarflexor weakness; other functional measures must be explored in order to provide an understanding of the limitations of plantarflexing gait and to help determine how much neuromuscular training will assist recovery from paresis after stroke.

Anonymous Patient Answer
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