Visual Feedback Reach Training for Ataxia

Overseen By Anthony J Gonzalez, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Disqualifiers: Dementia, Vision loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if special reach training with visual feedback can improve arm movements in people with ataxia, a condition affecting balance and coordination. Researchers are comparing two methods: one where participants see their hand's position while reaching and another where they receive simple success or failure feedback afterward. Individuals with cerebellar damage from a stroke, tumor, or degeneration who experience coordination issues may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to understanding innovative training methods that could enhance coordination in individuals with ataxia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that reach training with visual feedback is safe for improving reaching movements in people with ataxia?

Research on visual feedback reach training has shown it to be generally safe. Studies involving both healthy individuals and those with conditions like stroke have not reported major safety issues. Participants in these studies performed similar training exercises and managed them well. Although specific information on side effects is not available, the overall evidence suggests that the training is well-tolerated. This is encouraging for those considering participation in clinical trials using this method. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the reach training with visual feedback for ataxia because it offers a unique approach to improving motor control. Unlike traditional physical therapy that focuses on repetitive exercises, this method uses technology to provide immediate visual feedback, helping patients understand and adjust their movements more precisely. The treatments include two types of training: one with continuous visual guidance via a cursor and another that uses binary feedback to encourage learning through reinforcement. This innovative method not only aims to enhance coordination but also empowers patients to actively participate in their rehabilitation, potentially accelerating progress.

What evidence suggests that this trial's treatments could be effective for ataxia?

Research has shown that special training exercises with visual feedback can improve arm movements in people with ataxia, a condition affecting balance and coordination. In this trial, participants will engage in different training methods. Specifically, studies have found that reinforcement training, one method in this trial, where participants receive simple feedback on their performance, can reduce movement mistakes in patients with cerebellar damage. This method provides feedback after each attempt, allowing patients to adjust their movements over time. Another method in this trial is traditional reach training, where participants continuously see their hand position, which helps improve their aim. Both methods aim to make reaching movements more accurate and controlled. ^{1 2 5 6 7}

Who Is on the Research Team?

Amy J Bastian, PhD, PT

Principal Investigator

Kennedy Krieger Institute and Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals aged 22-80 with cerebellar ataxia due to stroke, tumor, or degeneration. It's not suitable for those with extrapyramidal symptoms, vestibular loss, sensory neuropathy, significant pain or dementia (Mini-Mental State exam score > 22), vision loss affecting task performance, or damage to brain areas outside the cerebellum.

Inclusion Criteria

I am between 22 and 80 years old.

I have damage to my cerebellum due to stroke, tumor, or degeneration.

Exclusion Criteria

My vision loss affects my daily activities.

My pain stops me from doing daily tasks.

I have movement disorders, balance issues, or numbness in my limbs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo reinforcement or standard practice training for reaching movements over a 12-week period

12 weeks

3 visits per week

Rest Period

Participants have a rest period between training phases

2 weeks

Follow-up

Participants are monitored for retention of training effects

2 weeks

2 visits

What Are the Treatments Tested in This Trial?

Interventions

• Reach training with visual feedback

Trial Overview The study tests a reinforcement-based training method against standard practices over several weeks to improve reaching movements in people with ataxia. Participants will receive reach training that includes visual feedback.

How Is the Trial Designed?

Group I: Standard Practice Training Experimental Treatment 1 Intervention

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For standard practice, participants will be able to see a cursor that represents the position of the hand at all times and try to make straight reaches to the targets. This type of feedback provided specific information about the location of the hand.

Group II: Reinforcement Training Experimental Treatment 1 Intervention

Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed. During training the participant will reach a total of 400 times. For reinforcement training, participants will not see their hand or a cursor, but instead participants will receive target-specific binary feedback after each reach (i.e. based on running average of last 10 reaches to that target). Binary feedback indicates only whether the reach was successful or unsuccessful and provides no specific information about the location of the hand.

Reach training with visual feedback is already approved in United States for the following indications:

Approved in United States as Reach training with visual feedback for:

• Cerebellar ataxia

Who Is Running the Clinical Trial?

Hugo W. Moser Research Institute at Kennedy Krieger, Inc.

Lead Sponsor

Trials

93

Recruited

25,200+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

Nonvisual feedback methods, particularly vibrotactile feedback, significantly improved movement correction in physical exercise, with a 11.2% increase in accuracy compared to no feedback, based on a study with 22 participants with normal vision.

Pilot testing with participants with impaired vision indicated that vibrotactile and multimodal feedback were also effective, suggesting these methods could enhance exercise performance and safety for individuals with vision impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibrotactile feedback on yoga practice. Islam, MS., Lee, SW., Harden, SM., et al.[2022]

In a study involving 20 stroke patients, visual feedback training significantly improved static and dynamic balance compared to unstable surface training after 4 weeks of intervention.

Both training methods enhanced balance parameters, but visual feedback training was more effective in reducing postural sway and improving stability limits, indicating its potential as a superior rehabilitation strategy for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the effects of visual feedback training and unstable surface training on static and dynamic balance in patients with stroke. Hwang, HS., Kim, JH., Choi, BR.[2020]

Visual feedback is more effective than verbal feedback in reducing trunk compensation during one-arm reaching exercises, as shown by decreased trunk movements in stroke survivors using an end-effector robot.

The study indicates that synchronized visual feedback can significantly improve trunk stability during rehabilitation, but it is limited by a small sample size, suggesting the need for further research in diverse patient groups and exercise types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Visual Feedback in Reducing Trunk Compensation During Arm Reaching for Home-Based Stroke Rehabilitation. Lee, SH., Song, WK.[2023]

Robotic therapy combined with visual feedback distortion can enhance rehabilitation for individuals with chronic stroke or traumatic brain injury by encouraging them to exceed their perceived performance limits.

In a six-week study involving two patients, both showed functional improvements, suggesting that this method can effectively help patients overcome learned nonuse and improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visual feedback distortion in a robotic environment for hand rehabilitation. Brewer, BR., Klatzky, R., Matsuoka, Y.[2016]

In a study involving 21 subjects with simulated ultra-low vision and 3 patients with advanced retinitis pigmentosa, it was found that reaching movements were systematically inaccurate, with deviations primarily downward and towards the dominant hand.

Auditory feedback training significantly improved the accuracy of reaching movements, reducing deviations after 100 trials, suggesting it could be an effective tool for helping individuals with very low vision correct their orientation when reaching for targets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

False reaching movements in localization test and effect of auditory feedback in simulated ultra-low vision subjects and patients with retinitis pigmentosa. Endo, T., Kanda, H., Hirota, M., et al.[2022]

A new visual distortion training method for stroke survivors, which simulates robot-assisted feedback without the actual robot, showed promising early results in improving motor skills during a bimanual virtual reality task.

Both treatment and control groups improved after three weeks of practice, with the treatment group showing a slight advantage, suggesting that visual feedback alone can be an effective and simpler alternative for rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation with Distorted Vision Perceived as Forces. Hajissa, E., Celian, C., Thielbar, KO., et al.[2020]

In a study involving 30 healthy participants, those who received online visual feedback (VFb) during a reaching task showed faster learning and greater accuracy compared to those who did not receive visual feedback (NoVFb).

While both groups adapted to the task, the NoVFb group demonstrated slower learning and used less effective strategies, particularly when reaching for more challenging targets, indicating that visual feedback plays a crucial role in optimizing motor learning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of online visual feedback on motor acquisition and retention when learning to reach in a force field. Batcho, CS., Gagné, M., Bouyer, LJ., et al.[2017]

Using a visual feedback-equipped reacher significantly reduced muscle activity in the flexor digitorum superficialis and extensor digitorum muscles during reach-to-grasp tasks, indicating less physical strain on the users.

The study, involving 17 healthy participants, also found that wrist momentum decreased when using the reacher with visual feedback, suggesting that this assistive device can help reduce physical fatigue and improve energy efficiency during tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a visual feedback-equipped reacher in reach-to-grasp movements. Do, JH., Yoo, WG.[2020]

A randomized controlled trial involving subjects training in a virtual environment showed that both groups improved in motor recovery after three weeks of training, suggesting that rehabilitation can continue to be effective even after a plateau is reached.

The group using Error-Augmentation (EA) demonstrated consistent advantages in improvement, indicating that visual feedback can enhance rehabilitation outcomes similarly to robotic-assisted therapies, while also introducing greater variability in performance between trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper Extremity Functional Rehabilitation for Stroke Survivors Using Error-Augmented Visual Feedback: Interim Results. Porta, F., Celian, C., Patton, JL.[2021]

Citations

1. withpower.com withpower.com/trial/phase-cerebellar-ataxia-7-2019-5d4a4

Visual Feedback Reach Training for Ataxia This trial compares two training methods to improve arm movements in people with cerebellar ataxia. It targets individuals who struggle with movement ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03879018

NCT03879018 | Retraining Reaching in Cerebellar Ataxia Reach training with visual feedback. During each training session, participants will first be familiarized with the task and then will reach from a home ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7927977/

Reinforcement signaling can be used to reduce elements of ... Our results suggest that binary reinforcement training can improve reaching movements in patients with cerebellar damage.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10669586/

Effectiveness of Vestibular Rehabilitation for Patients with ... This systematic review identified evidence for improvements with traditional physical and occupational therapy, as well as intensive ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03879018/retraining-reaching-in-cerebellar-ataxia?id=829&slug=Friedreich's%20Ataxia

Retraining Reaching in Cerebellar Ataxia The purpose of this study is to test for benefits of reinforcement based training paradigm versus standard practice over weeks for improving ...

6. withpower.com withpower.com/clinical-trials/for-cerebellar-ataxia

Top Cerebellar Ataxia Clinical Trials | Power Visual Feedback Reach Training for Ataxia. Baltimore, Maryland. This trial compares two training methods to improve arm movements in people with cerebellar ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9103288/

Preliminary Study of Vibrotactile Feedback during Home ... Vibrotactile SA may be a beneficial addition to training regimens for individuals with hereditary cerebellar ataxia, but additional research ...