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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Chronic Stroke

Treatments

Other: Standard Occupational Therapy Arm Exercise Program

Study type

Interventional

Funder types

Other

Identifiers

NCT05659875
HSC-MS-22-0434

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1 participants in 1 patient group

ARM-program
Experimental group
Treatment:
Other: Standard Occupational Therapy Arm Exercise Program

Trial contacts and locations

1

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Central trial contact

Emily Stevens, OTR; Sean Savitz, MD

Data sourced from clinicaltrials.gov

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