Health TrialsbyHealthPanel

Retraining Reaching in Cerebellar Ataxia

ConditionCerebellar Ataxia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-80
SponsorHugo W. Moser Research Institute at Kennedy Krieger, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cerebellar damage from stroke, tumor or degeneration

Age 22-80

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Reinforcement TrainingExperimental treatment 1 intervention
Group B: Standard Practice TrainingExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Assessed every study visit week 1 to week 12

Secondary outcomes

1

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.

Time frame
Assessed week 1 before the first training session, and week 12
2

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).

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

National Institutes of Health (NIH)

Collaborator

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

Collaborator

Source ClinicalTrials.gov
Apply now