search
Back to results

Fatiguing Arm Exercise Following Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
submaximal exercise (grip)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke focused on measuring hemiparesis

Eligibility Criteria

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

Inclusion Criteria:

  • individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis
  • Non-Veteran Participants are eligible

Exclusion Criteria:

  • multiple strokes
  • strokes in both hemispheres
  • brainstem/medullary/cerebellar stroke
  • seizure disorder
  • metal implants in head or neck
  • pacemaker or other implanted device
  • inability to produce any measurable grip force

Sites / Locations

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Task-failure, Extended Session

Arm Description

Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period

Outcomes

Primary Outcome Measures

Short Intracortical Inhibition (SICI)
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
SICI Ratio
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.

Secondary Outcome Measures

Full Information

First Posted
October 14, 2016
Last Updated
June 1, 2020
Sponsor
VA Office of Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT03194464
Brief Title
Fatiguing Arm Exercise Following Stroke
Official Title
Neural Mechanisms Mediating Interlimb Transfer Following Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2016 (Actual)
Primary Completion Date
May 21, 2018 (Actual)
Study Completion Date
May 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study investigates the effects of sub-maximal exercise to task-failure (e.g., fatigue) with the less involved, or so-called non-paretic hand, in people who have experienced a stroke. In previous work the investigators found that non-paretic hand exercise to task-failure increased excitability of the motor cortex in the more involved hemisphere and produced behavioral improvements in the unexercised paretic hand. Importantly, the magnitude of increased brain excitability is greater than what has been observed following brain stimulation with either repetitive transcranial magnetic stimulation (TMS) or transcranial direct current stimulation (tDCS) and lasts longer. This approach could be implemented in the clinical setting and could be accessible to a greater number of people than brain stimulation. The investigators' goals in the current study are to: repeat previous findings in a different group of participants and investigate the neural mechanisms that produce brain and behavioral facilitation in order to inform development of this approach for clinical implementation.
Detailed Description
The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand. The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis: . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure. . Behavioral effects using a motor task involving manipulation and dexterity. . Determine the persistence and consistency of neural and behavioral facilitation.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, repeated measures
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Task-failure, Extended Session
Arm Type
Experimental
Arm Description
Repeated sub-maximal gripping exercise with the less affected hand to task-failure - followed by repeated measurements (5) during recovery period
Intervention Type
Other
Intervention Name(s)
submaximal exercise (grip)
Intervention Description
participants perform repeated gripping with visual feedback to task failure
Primary Outcome Measure Information:
Title
Short Intracortical Inhibition (SICI)
Description
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
Time Frame
baseline, post task-failure (minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
Title
SICI Ratio
Description
SICI is a neurophysiologic measure of intra-cortical inhibition, obtained using transcranial magnetic stimulation (TMS) measured here in the ipsilesional hemisphere (IH) at each point to determine how it is modulated in response to task-failure. SICI is quantified as a ratio where values <1 reflect inhibition and >1 disinhibition or relative excitation. In health, SICI is ~0.5. Thus if SICI = 0.8, while <1 it would indicate less inhibition than expected in health. Transient change in SICI from 0.8 to 1.1 over the course of this experimental paradigm would reflect a period of relative excitation in response to the exercise paradigm.
Time Frame
Baseline, pre-exercise of 8 repeated sessions
Other Pre-specified Outcome Measures:
Title
Box and Blocks Test (BBT)
Description
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured at each time point: baseline, post-task failure, 45min post, 90min post, 135min post, 180min post, 225min post-task failure to determine the change in paretic hand BBT performance following exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
Time Frame
baseline, post task-failure (requires variable timeline from minutes to an hour), every 45 min up to 3.5 hours post-task-failure (7 points total)
Title
Box and Blocks Test (BBT)
Description
The BBT measures motor function/dexterity, scored as the number of blocks transferred in 1 minute. Here function of the paretic hand was measured prior to exercise at each of 8 repeated sessions conducted twice weekly for 4 weeks to determine the change in paretic hand BBT performance following repeated sessions of exercise to task-failure. Scores are numeric ranging from 0 (no blocks transferred) to whatever the participant is able to achieve. Healthy age-matched adults without motor disability score in the range of 60 (+/- 10) blocks transferred in 1 minute.
Time Frame
baseline, pre-exercise of 8 repeated sessions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: individuals at least 6 months post-stroke in the cortical or sub-cortical distribution with residual upper-extremity hemiparesis Non-Veteran Participants are eligible Exclusion Criteria: multiple strokes strokes in both hemispheres brainstem/medullary/cerebellar stroke seizure disorder metal implants in head or neck pacemaker or other implanted device inability to produce any measurable grip force
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolynn Patten, PhD
Organizational Affiliation
North Florida/South Georgia Veterans Health System, Gainesville, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Florida/South Georgia Veterans Health System, Gainesville, FL
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Fatiguing Arm Exercise Following Stroke

We'll reach out to this number within 24 hrs