Cerebellar AtaxiaNCT03879018
Retraining Reaching in Cerebellar Ataxia
A study testing Reach training with visual feedback in people with Cerebellar Ataxia, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Cerebellar Ataxia
- What is being tested?
- Reach training with visual feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebellar damage from stroke, tumor or degeneration
- Age 22-80
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Motion Analysis Lab in the Kennedy Krieger Institute
Baltimore, Maryland, 21205
Anthony J Gonzalez, BS, 443-923-2716, gonzalezan@kennedykrieger.org
Amy J Bastian, PhD, PT
About this study
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.
Read the detailed description
Damage to the cerebellum produces characteristic deficits in movement coordination, known as "ataxia." Reaching movements become curved, tremulous, and over- or undershoot targets, thus affecting nearly all activities of daily living. Sitting and standing balance becomes unsteady, and walking has a characteristic 'drunken' appearance with lateral veering and a widening of the base of support. People with many types of neurological diseases (e.g. autosomal dominant ataxias (e.g. SCAs), multiple sclerosis, cerebral palsy, stroke, Freidreich's ataxia) often have disabling ataxia.
In past work the investigators have shown that many individuals with ataxia from cerebellar disease can learn simple visuomotor tasks using reinforcement learning paradigms. The investigators do not know if individuals with ataxia from cerebellar disease can improve more complex motor patterns. In general, there are few rehabilitation studies on ataxia, with most focusing on balance and walking. Yet, arm ataxia is a significant problem that affects most all activities of daily living (e.g. eating, cooking, bathing, dressing, working). Many studies have assessed reaching ataxia on single days in order to try to better understand the fundamental basis for ataxic arm movements. Based on previous literary searches, there are only a couple of small studies that have tested whether training over weeks can mitigate arm ataxia. Each of these was a case series of either 3 or 4 people, and all patients had ataxia from lesions that included structures outside of the cerebellum. Both showed some positive effects but responses varied across patients. This work that the investigators propose will look at the affects of a longer training regimen of upper limb reaching in people with cerebellar ataxia.
The investigators will study cerebellar patients that have shown the ability to learn from previous work. Subjects with cerebellar ataxia will be randomized into two groups to receive either reinforcement training or standard practice training over a 12 week period. Subjects will train for 45 minutes a day, 3 times per week for two weeks for each type of training, with a two week 'rest' period in between. After training, subjects will be asked to return for two visits to test for retention. On each training day, reinforcement training (or standard practice) will be done using an Oculus Rift and Touch 3D headset. Training encompasses reaching to a 3D target with either online visual feedback or binary feedback 400 times. Motion tracking sensors will be placed on the shoulder, elbow, wrist, and finger, in order to track movement data in real time. These studies will provide important new information about upper limb long term training with visual feedback in individuals with Cerebellar Ataxia
- Conditions
- Cerebellar Ataxia
- Being tested
- Reach training with visual feedback
- Keywords
- Cerebellar Ataxia
- Medical subject headings
- Cerebellar Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reach training with visual feedbackBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Reach training with visual feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed every study visit week 1 to week 12
Secondary outcomes (2)
ICARS (International Cooperative Ataxia Rating Scale)
ICARS is a standardized scale used to quantify the level of impairment in people with cerebellar ataxia. The ICARS is a 0- 100 point scale system with four subscales that include, postural and gait disturbances, limb ataxia, dysarthria, and Oculomotor disorders. Postural and gait disturbances are scaled 0 to 34 points. Limb ataxia is scaled 0 to 52 points. Dysarthria is scaled 0 to 8 points, and Oculomotor disorders is scaled 0 to 6 points. The higher the score indicates greater impairment.
Measured: Assessed week 1 before the first training session, and week 12
ARAT ( Action Research Arm Test)
The ARAT is an assessment used to measure changes in upper limb function in people who have experienced damage or disease to the nervous system (e.g., multiple sclerosis, stroke, Parkinson's disease, cerebellar ataxia).
Measured: Assessed week 1 before the first training session, and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start1 Aug 2019
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebellar AtaxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Amy J. Bastian, Ph.D., Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Amy J Bastian, PhD, PT, Principal investigator, Kennedy Krieger Institute and Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879018
- Sponsor's protocol ID
- IRB00182673
- Other IDs
- 2R01HD040289-15A1
- Status last verified
- Jun 2026
- First submitted
- 8 Mar 2019
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retraining Reaching in Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT03879018
- Acronym / sponsor ID
- IRB00182673
- Conditions
- Cerebellar Ataxia
- Keywords
- Cerebellar Ataxia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 18 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Damage to the cerebellum produces characteristic deficits in movement coordination, known as "ataxia." Reaching movements become curved, tremulous, and over- or undershoot targets, thus affecting nearly all activities of daily living. Sitting and standing balance becomes unsteady, and walking has a characteristic 'drunken' appearance with lateral veering and a widening of the base of support. People with many types of neurological diseases (e.g. autosomal dominant ataxias (e.g. SCAs), multiple sclerosis, cerebral palsy, stroke, Freidreich's ataxia) often have disabling ataxia.
In past work the investigators have shown that many individuals with ataxia from cerebellar disease can learn simple visuomotor tasks using reinforcement learning paradigms. The investigators do not know if individuals with ataxia from cerebellar disease can improve more complex motor patterns. In general, there are few rehabilitation studies on ataxia, with most focusing on balance and walking. Yet, arm ataxia is a significant problem that affects most all activities of daily living (e.g. eating, cooking, bathing, dressing, working). Many studies have assessed reaching ataxia on single days in order to try to better understand the fundamental basis for ataxic arm movements. Based on previous literary searches, there are only a couple of small studies that have tested whether training over weeks can mitigate arm ataxia. Each of these was a case series of either 3 or 4 people, and all patients had ataxia from lesions that included structures outside of the cerebellum. Both showed some positive effects but responses varied across patients. This work that the investigators propose will look at the affects of a longer training regimen of upper limb reaching in people with cerebellar ataxia.
The investigators will study cerebellar patients that have shown the ability to learn from previous work. Subjects with cerebellar ataxia will be randomized into two groups to receive either reinforcement training or standard practice training over a 12 week period. Subjects will train for 45 minutes a day, 3 times per week for two weeks for each type of training, with a two week 'rest' period in between. After training, subjects will be asked to return for two visits to test for retention. On each training day, reinforcement training (or standard practice) will be done using an Oculus Rift and Touch 3D headset. Training encompasses reaching to a 3D target with either online visual feedback or binary feedback 400 times. Motion tracking sensors will be placed on the shoulder, elbow, wrist, and finger, in order to track movement data in real time. These studies will provide important new information about upper limb long term training with visual feedback in individuals with Cerebellar Ataxia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reinforcement Training | Experimental | Behavioral: Reach training with visual feedbackReach 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. |
| Standard Practice Training | Experimental | Behavioral: Reach training with visual feedbackReach 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. |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cerebellar damage from stroke, tumor or degeneration
- Age 22-80
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reach training with visual feedbackReach 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 | Behavioural | Reinforcement Training, Standard Practice Training |
Primary outcome
Hand path distance during natural reaching to the trained target locations.
Time frame: Assessed every study visit week 1 to week 12
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.
2 secondary outcomes
ICARS (International Cooperative Ataxia Rating Scale)
Time frame: Assessed week 1 before the first training session, and week 12
ARAT ( Action Research Arm Test)
Time frame: Assessed week 1 before the first training session, and week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy J Bastian, PhD, PT principal investigator
Kennedy Krieger Institute and Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reach training with visual feedback in people with Cerebellar Ataxia, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony J Gonzalez, BS (4439232716, agonza30@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand path distance during natural reaching to the trained target locations. (time frame: Assessed every study visit week 1 to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.