Fatiguing Arm Exercise Following Stroke

NCT ID: NCT03194464

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2018-05-21

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:

1. . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure.

2. . Behavioral effects using a motor task involving manipulation and dexterity.

3. . Determine the persistence and consistency of neural and behavioral facilitation.

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Task-failure, Extended Session

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

Group Type: EXPERIMENTAL

submaximal exercise (grip)

Intervention Type: OTHER

participants perform repeated gripping with visual feedback to task failure

Interventions

submaximal exercise (grip)

participants perform repeated gripping with visual feedback to task failure

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carolynn Patten, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Gainesville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

N1759-P

Identifier Type: -

Identifier Source: org_study_id