Neurophysiological and Kinematic Predictors of Response in Chronic Stroke
SRT4
2 other identifiers
interventional
68
1 country
2
Brief Summary
The purpose of this study is to design a predictive model of stroke recovery based on baseline measurements of arm movement and brain physiology. The expectation is the development of a formula to predict a person's response to an arm rehabilitation program provided in the chronic phase (6 months or greater post stroke) of recovery. The study will include magnetic resonance imaging (MRI), transcranial magnetic stimulation (TMS), genetic testing using blood and saliva, and an arm exercise program consisting of robot-assisted exercise combined with functional arm exercise called transition to task training (TTT).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Feb 2016
Longer than P75 for not_applicable stroke
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 20, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 28, 2019
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedMarch 2, 2021
February 1, 2021
3.7 years
December 23, 2015
November 24, 2020
February 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Stroke Impact Scale: Hand
The Stroke Impact Scale (SIS) is one of the primary outcome measures assessing change in hand 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 self-report structured interview consisting of eight domains designed to assess physical, mental and emotional changes following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domain subscales that can be analyzed separately. The SIS hand subscale will be the focus for our outcome measure. Higher scores indicate greater function and life satisfaction. The minimum and maximum for the subscale is 0 and 100 respectively.
Baseline, after visit 36, and 12 week retention
Fugl-Meyer Upper Extremity Assessment
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.
Baseline, after visits 12, 24, and 36, and 12 week retention
Secondary Outcomes (2)
Action Research Arm Test (ARAT)
Baseline, after visits 12, 24, and 36, and 12 week retention
6-Item Wolf Motor Function Test (WMFT)
Baseline, after visits 12, 24, and 36, and 12 week retention
Other Outcomes (1)
TMS Score: Three Muscle Responses to Transcranial Magnetic Stimulation of the Motor Cortex
Baseline, after visit 36, and 12 week retention
Study Arms (1)
Device: Robot + TTT Exercise
EXPERIMENTALAll 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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 and not have contractures or other impairments that would interfere with the interventional training.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Related Publications (1)
Dimyan MA, Harcum S, Ermer E, Boos AF, Conroy SS, Liu F, Horn LB, Xu H, Zhan M, Chen H, Whitall J, Wittenberg GF. Baseline Predictors of Response to Repetitive Task Practice in Chronic Stroke. Neurorehabil Neural Repair. 2022 Jul;36(7):426-436. doi: 10.1177/15459683221095171. Epub 2022 May 26.
PMID: 35616437DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Total enrollment fell short of goals. There was some missing data in baseline measures, such as MRI or TMS.
Results Point of Contact
- Title
- George F. Wittenberg
- Organization
- VA Pittsburgh Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
George F. Wittenberg, MD PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The outcomes assessor is masked as to the prediction model and to particulars of performance during the intervention, but knows that there is a single group design.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2015
First Posted
January 20, 2016
Study Start
February 1, 2016
Primary Completion
October 28, 2019
Study Completion
October 28, 2019
Last Updated
March 2, 2021
Results First Posted
February 3, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
A de-identified, anonymized dataset will be created and shared. Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information. Datasets will be made available to the public following appropriate approvals for disclosure criteria. Every effort will be made to protect personal privacy and the confidentiality of private information collected for research purposes. This particular dataset will be de-identified and the minimum amount of information necessary to achieve the objectives of the research proposed will be collected and shared.