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

CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Stroke
• Intervention / Treatment: Other: Standard Occupational Therapy Arm Exercise Program

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sean Savitz, MD; Phone Number: (713) 500-7083; Email: Sean.I.Savitz@uth.tmc.edu
• Study Contact Backup: Name: Emily Stevens, OTR; Phone Number: 713-500-7914; Email: emily.a.stevens@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas Health Science Center at Houston
      • Contact: Emily Stevens, OTR; Phone Number: 713-500-7914; Email: emily.a.stevens@uth.tmc.edu
      • Contact: Sean Savitz, MD; Phone Number: 713-500-7083; Email: Sean.I.Savitz@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARM-program	Other: 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.; Other Names: standard occupational therapy arm exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, month 4, month 8, month 12, month 16, month 20, month 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).	Baseline, month 24
Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation	Baseline, month 4, month 8, month 12, month 16, month 20, month 24

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Sean Savitz, MD, UTHealth Houston

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: December 12, 2022
• First Submitted That Met QC Criteria: December 12, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: stroke; chronic stroke; arm impairment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-MS-22-0434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No