Therapy to improve arm movement after stroke
Progressive Abduction Loading Therapy: A Phase IIb Stroke Rehabilitation Trial With Longitudinal Tracking
This study is testing a new therapy to help people who have had a stroke improve their arm movement so they can reach out better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 3 sites (Chicago, Illinois and 2 other locations) |
| Trial ID | NCT04118998 on ClinicalTrials.gov |
What this trial studies
This study aims to reduce a common movement impairment known as 'flexion synergy' that occurs after a stroke, making it difficult for patients to reach outward with their arm. Eighty-six individuals with severe hemiparetic stroke will be recruited upon admission to the Shirley Ryan AbilityLab for rehabilitation. Participants will receive either experimental or comparison therapy in addition to standard rehabilitation treatments and will be monitored for one year to assess their progress. Evaluations will occur weekly during therapy and bi-monthly after discharge.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who have experienced a severe hemiparetic stroke within the last 90 days.
Not a fit: Patients with pre-existing disabilities or chronic neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly improve arm mobility and overall rehabilitation outcomes for stroke patients.
How similar studies have performed: Other studies have shown promise in using targeted rehabilitation approaches for stroke recovery, suggesting potential for success in this novel intervention.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Hemiparesis confined to one side, (CMSA Stage 2 or 3 out of 7) 2. Stroke impacting parenchyma of the middle cerebral artery distribution 3. Within 90 days post-stroke 4. 18 to 85 years old 5. No or Mild-to-moderate Aphasia (NIHSS #9 Best Language. = 0 or 1- Describe picture; No or Mild-to-moderate Aphasia) 6. No or Mild extinction and inattention (NIHSS 11 Extinction and Inattention. = 0 or 1- No abnormality or Inattention to one modality.) 7. Ability to perform a 3-step motor command with the unaffected arm 8. Capacity to provide informed consent Exclusion Criteria: 1. Premorbid and persistent disability or motor impairment of the upper extremities 2. Brainstem and/or cerebellar lesion 3. Comorbidity medically contraindicating motor assessments 4. Any other chronic neurological condition 5. Pain or hypersensitivity limiting motor assessments 6. Limb edema limiting study motor assessments
Where this trial is running
Chicago, Illinois and 2 other locations
- Department of Physical Therapy and Human Movement Sciences — Chicago, Illinois, United States (Active_not_recruiting)
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
- Northwestern Medicine Marianjoy Rehabilitation Hospital — Wheaton, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Michael D Ellis, PT, DPT — Northwestern University
- Study coordinator: Michael D Ellis, PT, DPT
- Email: m-ellis@northwestern.edu
- Phone: 3125034435
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.