Retraining Reaching in Cerebellar Ataxia

NCT03879018 | Recruiting

• 2 other identifiers: IRB001826732R01HD040289-15A1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test for benefits of reinforcement based training paradigm versus standard practice over weeks for improving reaching movements in people with ataxia.

Conditions

Cerebellar Ataxia

Keywords

Cerebellar Ataxia

Outcome Measures

Primary Outcomes (1)

• Hand path distance during natural reaching to the trained target locations.

  Hand path distance is the percent above an ideal (straight reach) averaged over reaches to all 4 targets. To collect this measure, investigators will use motion capture equipment to record the positions of active markers that subjects will wear on their shoulder, elbow, wrist, and finger.

  Assessed every study visit week 1 to week 12

Secondary Outcomes (2)

• ICARS (International Cooperative Ataxia Rating Scale)

  Assessed week 1 before the first training session, and week 12

• ARAT ( Action Research Arm Test)

  Assessed week 1 before the first training session, and week 12

Study Arms (2)

Reinforcement Training

EXPERIMENTAL

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.

Behavioral: Reach training with visual feedback

Standard Practice Training

EXPERIMENTAL

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.

Behavioral: Reach training with visual feedback

Interventions

Reach training with visual feedback BEHAVIORAL

Reach training will be accomplished using an Oculus Rift and Touch 3D headset. Active markers will be placed on the shoulder, elbow, wrist, and finger in order to capture limb movement in real time. 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.Targets will be presented in a pseudorandom order and participants will reach a total of 400 times

Reinforcement Training; Standard Practice Training

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cerebellar damage from stroke, tumor or degeneration
• Age 22-80

You may not qualify if:

• Clinical or MRI evidence of damage to extracerebellar brain (e.g. multiple system atrophy)
• Extrapyramidal symptoms, peripheral vestibular loss, or sensory neuropathy
• Dementia ( Mini-Mental State exam \> 22)
• Pain that interferes with the tasks
• Vision loss that interferes with the tasks

Sponsors & Collaborators

• Hugo W. Moser Research Institute at Kennedy Krieger, Inc.: lead
• National Institutes of Health (NIH): collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Motion Analysis Lab in the Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Cerebellar Ataxia

Interventions

Feedback, Sensory

Condition Hierarchy (Ancestors)

Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Feedback, Physiological; Homeostasis; Physiological Phenomena

Study Officials

• Amy J Bastian, PhD, PT

  Kennedy Krieger Institute and Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony J Gonzalez, BS

CONTACT

4439232716; agonza30@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neuroscience

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 18, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Locations

US (1)