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CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program

NCT ID: NCT05659875

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-21

Study Completion Date

2024-03-21

Brief Summary

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The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.

Detailed Description

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Conditions

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Chronic Stroke

Keywords

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chronic stroke stroke arm impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARM-program

Group Type EXPERIMENTAL

Standard Occupational Therapy Arm Exercise Program

Intervention Type OTHER

Standard exercise program will be provided addressing shoulder, elbow, forearm, wrist, and hand with expectation that participant will complete 3 times a week. Exercise program will be updated at assessment timepoints as needed with change in arm function.

Interventions

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Standard Occupational Therapy Arm Exercise Program

Standard exercise program will be provided addressing shoulder, elbow, forearm, wrist, and hand with expectation that participant will complete 3 times a week. Exercise program will be updated at assessment timepoints as needed with change in arm function.

Intervention Type OTHER

Other Intervention Names

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standard occupational therapy arm exercises

Eligibility Criteria

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Inclusion Criteria

* Single qualifying stroke event as confirmed by CT or MRI
* At least 1 month post stroke
* Score of at least 2-/5 on Manual Muscle Test for wrist flexors or extensors, indicating adequate movement to complete robotic device use
* Able to follow written instructions

Exclusion Criteria

* Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
* Underlying brain pathologies such as metastatic or primary brain malignancies, comorbid multiple sclerosis, etc.
* Prior significant drug or alcohol abuse
* Diagnosed with dementia
* Pre-stroke baseline modified Rankin Scale (mRS) \>3
* History of seizure/epilepsy
* History of clinically significant ischemic or hemorrhagic stroke prior to index stroke resulting in prior arm injury or weakness.
* Pregnancy
* Contraindication to MRI or Transcranial Magnetic Stimulation (TMS).
* Medical instability assessed by the treating stroke physician to participate to the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Sean Savitz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sean Savitz, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth Houston

Locations

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The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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HSC-MS-22-0434

Identifier Type: -

Identifier Source: org_study_id