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Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tracking training
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria include:

  • Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke
  • Subcortical location of stroke
  • Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002)
  • At least 18 years of age - to maximize pool of candidate subjects
  • Mini-Mental State Examination score >24 - to ensure satisfactory cognition to perform tasks
  • Satisfactory corrected vision - to see computer screen during training and testing
  • Active range of MP joint at paretic index finger of at least 10 degrees - based on minimal movement required to perform training task successfully, and that larger amplitudes would reduce the pool of subjects available for participating in the study.
  • Ability to pronate the forearm so that index finger extension movement during training is vertically upward and relaxation results in the finger falling back to the flexed starting position
  • not currently receiving any other therapy - to avoid confounding treatment effects
  • Approval for participation by a neurologist - to ensure subject is reasonably safe to receive TMS testing. Subjects with proprioceptive loss or expressive aphasia will be included, providing they can carryout the training task.

Exclusion criteria include:

  • Inability to follow 3-step commands
  • A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them
  • History of seizures
  • Family member with history of seizures
  • Presence of any other neuromuscular disorders
  • Pregnancy
  • Claustrophobia
  • Indwelling metal or medical devices/implants incompatible with functional fMRI testing
  • History of exposure to finger tracking training.
  • Informed consent will be obtained and TMS/fMRI safety screenings will be conducted prior to testing procedures.
  • Subjects will be recruited as volunteers from letters sent to previous research subjects inviting their participation, through visits to local stroke support groups meetings, newspaper advertisements and referrals from neurologists.

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Slow tracking training

Fast tracking training

Arm Description

Outcomes

Primary Outcome Measures

Hand function improvement
Jebsen Taylor test, Box & Block Test, and Finger extension force test

Secondary Outcome Measures

corticospinal excitability
TMS
cognitive function

Full Information

First Posted
March 19, 2012
Last Updated
October 30, 2019
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01575366
Brief Title
Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke
Official Title
Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aim 1. Determine whether higher-velocity finger tracking training improves hand function more than slower velocity training. Working hypotheses: The higher-velocity training will have significantly greater functional improvement compared to the lower-velocity training, as measured by standardized upper extremity functional tests (Jebsen Taylor test, Box & Block Test, and Finger extension force test) Aim 2. Ascertain whether higher-velocity finger tracking training differentially induces cortical reorganization as compared to lower-velocity finger tracking training. Working hypotheses: The higher-velocity training will have significantly greater cortical reorganization compared to the lower-velocity training, as measured by: TMS - increased amplitude of motor evoked potentials (MEP) from paretic extensor digitorum muscle in response to paired-pulse TMS to ipsilesional primary motor area (M1). fMRI - increased volume of activation, signal intensity, and laterality of ipsilesional M1. Aim 3. Explore whether the functional improvements correlate with the cortical reorganization. Working hypotheses: The functional improvements will correlate with the cortical reorganization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Slow tracking training
Arm Type
Experimental
Arm Title
Fast tracking training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Tracking training
Intervention Description
The paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases.
Primary Outcome Measure Information:
Title
Hand function improvement
Description
Jebsen Taylor test, Box & Block Test, and Finger extension force test
Time Frame
taken at weekly intervals for the whole study length, 20 weeks.
Secondary Outcome Measure Information:
Title
corticospinal excitability
Description
TMS
Time Frame
taken at weekly intervals for the whole study length, 20 weeks.
Title
cognitive function
Time Frame
at the beginning and at the end of the study, which are 1st and 20th week.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria include: Ischemic stroke - due to higher risk of seizures in hemorrhagic stroke Subcortical location of stroke Stroke after 6 months - lower limit of 6 months to avoid confounding from spontaneous recovery (Jorgensen, Nakayama et al. 1995) and no upper limit to maximize pool of candidate subjects while still showing training effect (Carey, Kimberley et al. 2002) At least 18 years of age - to maximize pool of candidate subjects Mini-Mental State Examination score >24 - to ensure satisfactory cognition to perform tasks Satisfactory corrected vision - to see computer screen during training and testing Active range of MP joint at paretic index finger of at least 10 degrees - based on minimal movement required to perform training task successfully, and that larger amplitudes would reduce the pool of subjects available for participating in the study. Ability to pronate the forearm so that index finger extension movement during training is vertically upward and relaxation results in the finger falling back to the flexed starting position not currently receiving any other therapy - to avoid confounding treatment effects Approval for participation by a neurologist - to ensure subject is reasonably safe to receive TMS testing. Subjects with proprioceptive loss or expressive aphasia will be included, providing they can carryout the training task. Exclusion criteria include: Inability to follow 3-step commands A visual field cut that causes subjects not to see all indicators on a computer screen positioned centrally in from of them History of seizures Family member with history of seizures Presence of any other neuromuscular disorders Pregnancy Claustrophobia Indwelling metal or medical devices/implants incompatible with functional fMRI testing History of exposure to finger tracking training. Informed consent will be obtained and TMS/fMRI safety screenings will be conducted prior to testing procedures. Subjects will be recruited as volunteers from letters sent to previous research subjects inviting their participation, through visits to local stroke support groups meetings, newspaper advertisements and referrals from neurologists.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huiqiong Deng, MD, MS
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Movement Velocity Effect on Cortical Reorganization and Finger Function in Stroke

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