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

NCT05659875 | Completed

• 1 other identifier: HSC-MS-22-0434
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Stroke

Keywords

chronic stroke; stroke; arm impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (1)

ARM-program

EXPERIMENTAL

Other: Standard Occupational Therapy Arm Exercise Program

Interventions

Standard Occupational Therapy Arm Exercise Program 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.

Also known as: standard occupational therapy arm exercises

ARM-program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sean Savitz, MD

  UTHealth Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: December 21, 2022
• Study Start: February 21, 2023
• Primary Completion: March 21, 2024
• Study Completion: March 21, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)