Remediation of the Non-Paretic Arm in Stroke

NCT03062930 | Completed

• 2 other identifiers: STUDY0000293716GRNT31010001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Stroke survivors with severe contralesional paresis often have substantial control and coordination deficits in the non-paretic arm. Because this arm must serve as the primary controller, these deficits can be functionally devastating. The investigators now hypothesize that the combination of severe paresis (Upper Extremity Fugl-Meyer Score ≤35) and persistent motor deficits in the non-paretic arm limits functional independence in chronic stroke survivors. The investigators predict that remediation, focused on the non-paretic arm should improve functional independence. The investigators propose a randomized study design with two tracts, two periods and four assessments. The investigators envision this study as the first step in establishing the basis for a rehabilitation approach that focuses on remediation of BOTH arms, which constitutes a substantial change from current remediation protocols focused only on the contralesional arm.

Conditions

Stroke

Keywords

stroke; hemiparesis; lesion hemisphere; ipsilesional deficits; contralesional deficits; rehabilitation; remediation; paretic arm

Outcome Measures

Primary Outcomes (1)

• Change in performance time on Jebsen Taylor Hand Function Test

  test of unimanual arm function on the non-paretic arm

  week -3, week 0, week 3, week 6, week 9

Secondary Outcomes (4)

• Change in Barthel Index

  week -3, week 0, week 3, week 6, week 9

• Change in Kinematic analysis

  week -3, week 0, week 3, week 6, week 9

• Change in Grooved Pegboard

  week -3, week 0, week 3, week 6, week 9

• Change in Upper Extremity Fugl Meyer Assessment

  week -3, week 0, week 3, week 6, week 9

Study Arms (2)

Track 1

ACTIVE COMPARATOR

Training of non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks followed by sham condition (playing board games/computer games) for 3 weeks

Behavioral: Track 1; Behavioral: Track 2

Track 2

SHAM COMPARATOR

Sham condition (playing board games/computer games) for 3 weeks followed by training of the non-paretic arm for 3 weeks consisting of occupational therapy and kinematic tasks

Behavioral: Track 1; Behavioral: Track 2

Interventions

Track 1 BEHAVIORAL

Training of non-paretic arm followed by sham condition

Also known as: remediation of non-paretic arm followed by sham training

Track 1; Track 2

Track 2 BEHAVIORAL

Same procedures as track 1, but completed in opposite order, starting with sham condition followed by the non-paretic arm training

Also known as: sham condition followed by remediation of non-paretic arm

Track 1; Track 2

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be between 21 and 85 years old of either gender
• Subjects will demonstrate cognitive abilities required to follow commands and engage in the experimental task
• Subjects will have had a unilateral stroke at least 3 months prior to participation resulting in upper extremity motor deficits

You may not qualify if:

• hospitalization for substance abuse and/or a major psychiatric diagnosis (schizophrenia);
• non-stroke neurological diseases that may affect ability to perform task or upper limb motor function
• certain peripheral movement restrictions, such as neuropathy
• neuroradiological confirmation of concomitant damage to the cerebellum or brain stem or extensive periventricular white matter changes (based on consultation with neuroradiology)

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State College of Medicine; Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Sainburg, Phd

  Penn State College of Medicine, Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology and Neurology

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: February 24, 2017
• Study Start: August 20, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)