Functional Neuroimaging and Motor Recovery After Stroke

Part of paid clinical trials in Newark, Delaware.

Sponsor
University of Delaware
Study ID
NCT07666165
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
35 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Conventional Physical Therapy Intervention — BEHAVIORAL
    The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.

Study Details

The primary goal of this project is to establish whether fMRI measurements of brain connectivity measured before and after interaction with a sensorimotor task can predict subsequent training-induced gains in motor function in a population of individuals with chronic stroke. This study involves individuals with chronic motor impairment resulting from stroke. The procedures include one fMRI session (baseline), followed by twelve training visits (2 or 3 times per week over 4-5 weeks) focused on training motor function of the hand and wrist conducted with a physical therapist. During imaging, participants interact with an MRI-compatible joystick that will cue participants to move their wrist in a controlled way. Before and after the training program, subjects will undergo behavioral testing with a physical therapist to quantify changes in clinical measures of impairment.

Key Dates

Start date
Jan 25, 2022
Status verified
May 2026
Primary completion
Dec 22, 2022
Completion
Dec 22, 2022

Study Design

Enrollment
14 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Conventional Physical Therapy Intervention
    The training sessions will consist of high repetitions of finger flexion/extension and grip/object manipulation tasks, wrist flexion/extension and radial/ulnar deviation and forearm supination/pronation tasks performed while seated, standing or lying comfortably. All activities are typical of those conducted in physical therapy post-stroke except for the high number of repetitions. Some example tasks might include using a mallet to hammer pegs into a hole, pouring water from one cup into another, or spinning a pencil with the fingertips. Difficulty of tasks will be scaled to the capability level of each individual so that at least 200 repetitions of each exercise can be completed with 50-85% accuracy and a patient-reported difficulty of 5-9 out of 10.

Primary Outcome Measure

Goodness of fit (R^2) of a model predicting change in Upper Extremity Fugl-Meyer score from pre-post task changes in resting-state functional connectivity [ Time Frame: Brain connectivity is measured during the MRI visit conducted at Baseline. rsFMRI scans are collected within 10 minutes before and after a motor task. FM-UE is assessed once at Baseline and once at the end of the five week enrollment period. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Biomedical and Brain ImagingNewarkDelaware19713-
STAR Health Sciences ComplexNewarkDelaware19713-

Find similar trials in Newark, DE

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Center for Biomedical and Brain Imaging· Newark, DESTAR Health Sciences Complex· Newark, DE

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