Predictors of Response in Chronic Stroke

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-22

Study Completion Date

2020-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significant change in impairment at the end of a robot assisted therapy intervention.The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurophysiological and Kinematic Predictors of Response in Chronic Stroke

NCT02658630

Stroke

COMPLETED NA

Brain Connections for Arm Movement After Stroke

NCT04286516

Stroke Brain Disease Central Nervous System Diseases +2 more

RECRUITING NA

Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface

NCT03611855

Chronic Stroke Hemiparesis

TERMINATED NA

Functional Magnetic Resonance Imaging (fMRI) and Robot-Assisted Practice of Activities of Daily Living

NCT00878085

Hemiparesis Ischemic Stroke Chronic

COMPLETED PHASE1

Home-based Non-invasive Brain Stimulation and Hand Tracking Rehabilitation for People With Chronic Stroke

NCT02460809

Stroke

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

After informed consent, a baseline neurological exam, medical records review, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline testing will occur in the first 4-6 weeks of participation including two separate sessions approximately 1 week a part to examine arm strength, range of motion, and ability to perform functional tasks, with one additional session if needed to verify stability between results. Additionally, one robot evaluation will be completed.

The intervention phase consists of 12 weeks of robot and transition to task arm exercise training (TTT). Interventions will occur approximately 3 times per week for 12 weeks for a total of 36 visits. Additional time and visits will be allowed with visits occurring 4 times per week or up to 6 additional weeks (not to exceed 18 weeks) if scheduling conflicts arise. The intervention sessions will be one hour in duration.

During the hour-long intervention, 45 minutes of robotic intervention will be followed by 15 minutes of TTT. The training will be sequential with 12 sessions focused on the wrist, followed by 12 sessions on the shoulder-elbow and the final 12 sessions alternating between the wrist and elbow-shoulder.

After the final training session, subjects will return after a 12 week retention period. At various time points during and after the intervention phase there will be additional arm function testing, robot evaluations, questionnaires, MRI and TMS sessions for re-assessment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke Brain Diseases Central Nervous System Diseases Nervous System Diseases Cardiovascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

One-arm, multiple baseline sequential, cohort study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Robot + TTT Exercise

All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises.

Group Type EXPERIMENTAL

Robot + TTT exercise

Intervention Type DEVICE

The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Robot + TTT exercise

The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
* Stroke onset at least 6 months before enrollment
* Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
* Be medically stable to participate in the study
* Be English speaking

Exclusion Criteria

* Unable to give informed consent
* Have a serious complicating medical illness that would preclude participation.
* Contractures or orthopedic problems limiting range of joint motion in the potential study arm
* Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
* Botulinum toxin to study arm within four months of study enrollment or if received during the study period
* Unable to comply with requirements of the study
* Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
* Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions
* Have a serious complicating medical illness that would preclude participation

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No