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

Primary Purpose

Chronic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Occupational Therapy Arm Exercise Program
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring chronic stroke, stroke, arm impairment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at HoustonRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARM-program

Arm Description

Outcomes

Primary Outcome Measures

change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
This is a 33 item assessment and each is scored from 0 [unable to perform as instructed] - 2 [faultless performance] with a maximum score of 66. A higher number indicates better arm function.

Secondary Outcome Measures

Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).
Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation

Full Information

First Posted
December 12, 2022
Last Updated
March 29, 2023
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT05659875
Brief Title
CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program
Official Title
CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stroke
Keywords
chronic stroke, stroke, arm impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM-program
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standard Occupational Therapy Arm Exercise Program
Other Intervention Name(s)
standard occupational therapy arm exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment
Description
This is a 33 item assessment and each is scored from 0 [unable to perform as instructed] - 2 [faultless performance] with a maximum score of 66. A higher number indicates better arm function.
Time Frame
Baseline, month 4, month 8, month 12, month 16, month 20, month 24
Secondary Outcome Measure Information:
Title
Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).
Time Frame
Baseline, month 24
Title
Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation
Time Frame
Baseline, month 4, month 8, month 12, month 16, month 20, month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean Savitz, MD
Phone
(713) 500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
Organizational Affiliation
UTHealth Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Savitz, MD
Phone
713-500-7083
Email
Sean.I.Savitz@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Emily Stevens, OTR
Phone
713-500-7914
Email
emily.a.stevens@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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