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Completed

NCT Number: NCT05659875

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

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

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Key information

Conditions

Chronic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: standard occupational therapy arm exercises

Primary outcomes

  1. change in arm impairment as assessed by Fugl Meyer - Upper Extremity assessment

    Time frame: 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 outcomes

  1. Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).

    Time frame: Baseline, month 24

  2. 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

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 21, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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