CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 19 enrolled
Drug / intervention
Error-reduction +13 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02488031
NCT02488031N/ACompleted

Dysmetria in Motor Function in SCA: Mechanisms and Rehabilitation

University of Florida·interventional·Posted Jul 2, 2015·Updated May 13, 2019

In Brief

A clinical study evaluating Error-reduction, International Cooperative Ataxia Rating Scale, and 12 other interventions for Spinocerebellar Ataxia. Completed, enrolled 19 participants across 1 site.

Detailed Summary

The purpose of this research study is to investigate how the brain and motor behavior changes both in individuals with spinocerebellar ataxia and healthy individuals, and to assess whether a therapeutic intervention reduces levels of uncoordinated movement and improves motor function in spinocerebellar ataxia (SCA).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2, 2015
Enrollment StartMar 1, 2016
Primary CompletionJan 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11 years ago

Interventions

Error-reductionbehavioral

During this time participants will use a novel, custom designed computer interface to perform goal-directed movements with each leg in a 3D virtual environment designed to emphasize accurate movements. Leg movement will be detected using the LeapMotion sensor and we will quantify time endpoint errors by comparing the timing of the foot trajectory and the required time to target. The error-reduction intervention will be a 4-week home-based program. Each participant will train 4 days a week for approximately 1 hours per day. Within a week, the task difficulty will increase by changing the presentation of the targets to be more unpredictable and by increasing movement speed.

International Cooperative Ataxia Rating Scalebehavioral

The ICARS is an assessment of the ataxia severity. The ICARS score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.

Scale for the Assessment and Rating of Ataxiabehavioral

The SARA is an assessment of the ataxia severity. The SARA score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.

Beck Depression Inventory, 2nd Edbehavioral

This is a 21 question self-report inventory for measuring severity of depression.

Stroopbehavioral

This test measures selective attention and cognitive flexibility through reading aloud of color names or color of the print.

Purdue Pegboardbehavioral

This test consists of a series of timed hand coordination and dexterity tasks.

Brief Test of Attentionbehavioral

A cognitive test assessing focus and attention.

6-minute Walkbehavioral

This test consists on a timed 6-minute walk test to evaluate how much distance is covered.

Hand Grip Dynamometerbehavioral

This tests measures hand grip strength.

Montreal Cognitive Assessmentbehavioral

This test is used to assess cognitive abilities.

Physical Performance Functionbehavioral

This test consists of a series of physical activities used to evaluate speed, coordination, and ease of movement.

Biomechanical Assessments of Dysmetriabehavioral

Dysmetria will be assessed using a custom-made goal-directed movement protocol where participant perform unloaded limb movement tasks and attempt to reach a space-time target. During these task muscle activity is monitored using Electromyography (EMG) recording.

Neurophysiological assessment of brain activitybehavioral

Neurophysiology will be assessed by monitoring brain activity using Task-based fMRI and motor unit pool activity using a specialized EMG system.

Biomechanical gait analysisbehavioral

Participants will wear APDM's wireless sensors on the hands, legs, trunk and forehead and walk overground a distance of 7 m for 2 minutes. APDM quantifies 80 common biomechanical outcomes of gait (e.g. stride length variability).