Stroke Trial, Recruiting NCT07095920 Sponsor: University of Florida Condition: Stroke
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Stroke Trial, Recruiting

NCT07095920
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People whose affected arm has a specific level of partial movement impairment, measured by a standard stroke assessment tool called the Fugl-Meyer, with a score between 22 and 50 out of 66 (confirm with trial site)
  • People whose Fugl-Meyer arm score stayed roughly the same (within 3 points) between two early study visits
  • People aged 18 to 80 years old
  • People whose stroke was caused by a blocked blood vessel or a bleed within the brain
  • People who are between 6 months and 5 years past the date of their stroke
  • People whose affected arm can move at least one block in the Box & Block Test, a simple task involving moving small blocks within 60 seconds
  • People who are able to sit and use the study device for 40 minutes in a row
  • People who are able to follow a three-step spoken instruction, or an equivalent non-verbal instruction
  • People who are willing to take part in physical exercises during the study sessions
  • People who have a family member or carer available who is able to attend training and provide support during treatment sessions at the study site and at home throughout the study
  • Women who are not pregnant, not breastfeeding, and not planning a pregnancy during the study period
  • People who are able to give their own informed consent to participate

Who may not be able to join:

  • People with severe neglect (a condition where the brain ignores one side of the body or space) that would interfere with assessments or treatment
  • People with severe depression, based on a specific depression screening score (confirm with trial site)
  • People who have an implanted device that is not safe for use near MRI equipment, or who have a life-sustaining device such as a pacemaker or internal defibrillator
  • People with active epilepsy, people currently taking medication specifically for a seizure disorder, or people who have had any epileptic seizure in the past 5 years
  • People who have received Botulinum toxin (such as Botox) injections to the affected arm in the past 3 months, or for whom such injections are planned before the 6-month study visit
  • People with severe stiffness or muscle tightness in the affected arm, specifically a score of 3 or higher on a standard spasticity scale in the bicep or chest muscle
  • People with a pre-existing neurological condition (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, brain injury, or spinal cord injury) or a physical limitation that would significantly affect participation or make results harder to interpret
  • People with significant vision problems — whether pre-existing or caused by the stroke — that cannot be corrected and would significantly affect participation or make results harder to interpret
  • People with an unstable or serious medical condition (such as active cancer, severe heart failure, or a serious active psychiatric condition), or a life expectancy of less than 12 months
  • People with a history of alcohol or illicit drug misuse in the past 6 months that is likely to affect their ability to fully take part in the trial
  • People currently participating in another clinical trial that could conflict with this study
  • People who are currently receiving upper limb rehabilitation from a licensed therapist within 4 weeks of the screening visit and through to the primary study endpoint
  • Employees of the company sponsoring the trial
  • People who are currently in prison

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Emily Fox, PT, DPT, MHS, PhD, University of Florida & Brooks Rehabilitation

Phone: 904-742-2500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
27 August 2025
Est. completion
1 September 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Fugl-Meyer Assessment - Upper Extremity; Change from Baseline in Modified Rankin Scale (mRS)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov