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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05659875
• Other study ID #: HSC-MS-22-0434
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Sean Savitz, MD
• Phone: (713) 500-7083
• Email: Sean.I.Savitz[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

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