Patient Targeted Upper Extremity Rehabilitation After Stroke

NCT ID: NCT01819506

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-01
• Study Completion Date: 2017-03-31

Brief Summary

Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.

Detailed Description

The overwhelming majority of individuals who survive stroke have persistent upper extremity (UE) motor deficits which interfere with re-engagement in meaningful activities. While advances from neuroscience are spurring development of new rehabilitation strategies, the development of novel measurement methods has not kept pace. Currently, there is no comprehensive measurement framework to objectively quantify impairment, match a rehabilitation therapy program to a patient's impairment level, and measure specific therapy effects. Therefore there has not been a rehabilitation trial where a measurement framework is the basis for designing the treatment as well as defining the outcome. The investigators redesigned the Fugl-Meyer UE Assessment (FMA-UE) using item response theory Rasch analysis and developed a first of its kind measurement framework that locates a patient along a continuum of impairment and directs a personalized therapy program tailored to patients' specific impairments and ability levels. The purpose of this proposed research is to empirically test this framework.

The objective of this project is to empirically test the FMA-UE measurement framework.

This study hypothesizes that therapeutic task practice at the just-right challenge of difficulty will maximize post-stroke motor skill reacquisition. It is expected that "targeted task-practice", will increase UE motor ability because task goal difficulty will be matched and systematically progressed according to patients' initial and evolving levels of ability.

This is a single-blinded study with parallel arm design, stratified sampling and blocked randomization. 120 individuals with post-stroke UE hemiparesis will be enrolled; 40 participants per 3 UE impairment levels as defined by the investigators' measurement framework. Participants will engage in 12 sessions (3x/wk for 4 weeks, 2 hrs/session) of reach-to-grasp task-practice. Within each impairment level, subjects will be randomized to a treatment group; 20 to targeted task-practice and 20 to non-targeted task-practice. Targeted task-practice is personalized to patient-specific UE motor deficits with initial targets (goals) defined according to baseline measures and targets continually progressed after every 3 therapy sessions so that the goals match the patient's evolving level of ability. Non-targeted task practice is defined as a standard of care task-practice intervention intended to increase UE use but not alter specific impairments. Data analyses will include (1) ANOVA to test the effects of targeted vs. non-targeted therapy on UE motor ability, (2) multiple regression to model the relationship between therapy and movement adaptions occurring pre- to post-rehabilitation, and (3) growth mixture modeling to define responders and non-responders.

This project is significant because there is a pressing need for a comprehensive measurement framework to guide novel interventions designed to improve post-stroke UE motor function and define their effects.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Targeted Task Practice

Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.

Group Type: EXPERIMENTAL

Task Practice Physical Rehabilitation Therapy

Intervention Type: BEHAVIORAL

Similar to stroke rehabilitation occupational therapy.

Non-Targeted Task Practice

Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.

Group Type: ACTIVE_COMPARATOR

Task Practice Physical Rehabilitation Therapy

Intervention Type: BEHAVIORAL

Similar to stroke rehabilitation occupational therapy.

Interventions

Task Practice Physical Rehabilitation Therapy

Similar to stroke rehabilitation occupational therapy.

Intervention Type: BEHAVIORAL

Other Intervention Names

Task Practice

Eligibility Criteria

Inclusion Criteria

Individuals are eligible for this study if they have:

• experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
• exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
• impairment with overhead reach and wrist circumduction and fine motor dexterity.
• passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion Criteria

Individuals are not eligible for this study if they have:

• a lesion in the brainstem or cerebellum.
• another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
• pain in the affected upper extremity that would limit participation in the study intervention.
• difficulty understanding and following 3-step directions.
• difficulty sitting independently without postural support.
• an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
• are unable to travel to and remain in Charleston SC for the duration of the 4-week study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelle L. Woodbury, PhD

Role: PRINCIPAL_INVESTIGATOR

Ralph H. Johnson VA Medical Center, Charleston, SC

Locations

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States

Countries

United States

References

Woodbury ML, Velozo CA, Richards LG, Duncan PW, Studenski S, Lai SM. Dimensionality and construct validity of the Fugl-Meyer Assessment of the upper extremity. Arch Phys Med Rehabil. 2007 Jun;88(6):715-23. doi: 10.1016/j.apmr.2007.02.036.

Reference Type: BACKGROUND

PMID: 17532892 (View on PubMed)

Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.

Reference Type: BACKGROUND

PMID: 22234665 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

N0799-R

Identifier Type: -

Identifier Source: org_study_id