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

Not Applicable

Completed

• Conditions: Chronic Stroke
• Interventions: Other: Standard Occupational Therapy Arm Exercise Program

• Registration Number: NCT05659875
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-12
• Study First Submitted QC: 2022-12-12
• Study First Posted: 2022-12-21
• Study Start: 2023-02-21
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARM-program	Standard Occupational Therapy Arm Exercise Program	-

Primary Outcome Measures

Name	Time	Method
change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment	Baseline, month 4, month 8, month 12, month 16, month 20, month 24	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

Name	Time	Method
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

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States