Chronic StrokeNCT05659875
CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program
A study testing Standard Occupational Therapy Arm Exercise Program in people with Chronic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- Standard Occupational Therapy Arm Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2023to 21 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)
The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.
- Conditions
- Chronic Stroke
- Being tested
- Standard Occupational Therapy Arm Exercise Program
- Keywords
- chronic stroke, stroke, arm impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Occupational Therapy Arm Exercise ProgramOther
Also called standard occupational therapy arm exercises
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.
| Study group | Role | What they receive |
|---|---|---|
| ARM-program | Experimental | Not described Receives: Other: Standard Occupational Therapy Arm Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Baseline, month 24
Change in motor evoked potential as assessed by Transcranial Magnetic Stimulation
Measured: Baseline, month 4, month 8, month 12, month 16, month 20, month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start21 Feb 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Savitz, The University of Texas Health Science Center, Houston
- Investigators
- Sean Savitz, MD, Principal investigator, UTHealth Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659875
- Sponsor's protocol ID
- HSC-MS-22-0434
- Status last verified
- Dec 2024
- First submitted
- 12 Dec 2022
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CompARing Long terM Outcomes in Chronic Stroke Survivors Across Investigational Assessments Following a Prescribed Upper Extremity Exercise Program (ARM-PROGRAM)
- ClinicalTrials.gov ID
- NCT05659875
- Acronym / sponsor ID
- HSC-MS-22-0434
- Conditions
- Chronic Stroke
- Keywords
- chronic stroke, stroke, arm impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare assessments of arm function following a standard exercise program in chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARM-program | Experimental | Other: Standard Occupational Therapy Arm Exercise Program |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Occupational Therapy Arm Exercise ProgramAlso: standard occupational therapy arm exercisesStandard 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 | ARM-program |
Primary outcome
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.
2 secondary outcomes
Change in integrity of corticospinal tract fibers as assessed by MRI with Diffusion Tensor Imaging (DTI).
Time frame: Baseline, month 24
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Savitz, MD principal investigator
UTHealth Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Occupational Therapy Arm Exercise Program in people with Chronic Stroke, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.