- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879018
Retraining Reaching in Cerebellar Ataxia
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anthony J Gonzalez, BS
- Phone Number: 4439232716
- Email: agonza30@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21205
- Recruiting
- Motion Analysis Lab in the Kennedy Krieger Institute
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Contact:
- Anthony J Gonzalez, BS
- Phone Number: 443-923-2716
- Email: gonzalezan@kennedykrieger.org
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Principal Investigator:
- Amy J Bastian, PhD, PT
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Cerebellar damage from stroke, tumor or degeneration
- Age 22-80
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Reinforcement Training
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 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
|
Experimental: Standard Practice Training
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed every study visit week 1 to week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICARS (International Cooperative Ataxia Rating Scale)
Time Frame: Assessed week 1 before the first training session, and week 12
|
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.
|
Assessed week 1 before the first training session, and week 12
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ARAT ( Action Research Arm Test)
Time Frame: Assessed week 1 before the first training session, and week 12
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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).
|
Assessed week 1 before the first training session, and week 12
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amy J Bastian, PhD, PT, Kennedy Krieger Institute and Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00182673
- 2R01HD040289-15A1 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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