Predictors of Response in Chronic Stroke

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Stroke; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases
• Interventions: Device: Robot + TTT exercise

• Registration Number: NCT04283253
• Lead Sponsor: VA Pittsburgh Healthcare System

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-02-24
• Study First Posted: 2020-02-25
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Results First Submitted: 2021-12-06
• Status Verified: 2022-02
• Results First Submitted QC: 2022-03-01
• Last Update Submitted: 2022-03-01
• Results First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot + TTT Exercise	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.

Primary Outcome Measures

Name	Time	Method
A Change in the Fugl-Meyer Upper Extremity Assessment Score	Immediately following the 12-week intervention	The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.

Trial Locations

Locations (1)

VA Pittsburgh Healthcare System; 🇺🇸 Pittsburgh, Pennsylvania, United States