Comparing arm exercise methods for stroke recovery

Comparing Different Rehabilitation Exercise Strategies for Improving Arm Recovery After Stroke

This study is testing whether a special arm exercise program or a movable arm rest can help stroke patients recover better than regular rehab exercises.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 84 Years
• Sex: All
• Sponsor: University of California, Irvine (other)
• Locations: 3 sites (Downey, California and 2 other locations)
• Trial ID: NCT05880940 on ClinicalTrials.gov

What this trial studies

This research aims to evaluate the effectiveness of additional arm exercises alongside standard rehabilitation for stroke patients. Participants will be randomized to either a customized arm exercise program developed by a rehabilitation therapist or a movable wheelchair arm rest device that facilitates arm movement. The study will measure improvements in upper extremity motor recovery using the Fugl-Meyer Motor score over three months. The hypothesis is that the movable arm rest will yield greater recovery than conventional methods without increasing pain or spasticity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 84 who have experienced a stroke within the last 3 to 4 weeks and have a Fugl-Meyer Motor Score of less than 42.

Not a fit: Patients with severe shoulder pain or other neurological disorders affecting motor function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved arm recovery for stroke patients, enhancing their quality of life and independence.

How similar studies have performed: Other studies have shown promising results with similar rehabilitation approaches, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. 18 to 84 years of age
2. Experienced a single stroke or multiple strokes \>3 days and \< 4 weeks prior to study enrollment, and currently admitted or accepted into Acute Rehabilitation program for stroke.
3. UE Fugl-Meyer Motor Score \<42/66
4. Absence of moderate to severe shoulder pain while using the movable wheelchair arm rest device (\<6 on the 10-point visual analog pain scale)
5. Absence of severe tone at the affected UE (score \<4 on the Modified Ashworth Spasticity Scale)
6. Deem to be an appropriate candidate for manual wheelchair by ARU clinicians. A patient who has been able to transfer into a wheelchair while at ARU (with or without assistance) and has tolerated sitting in the wheelchair for at least 30 minutes.

Exclusion Criteria:

1. Subarachnoid hemorrhage
2. Presence of other neurological or psychological disorders affecting motor functions
3. Moderate to severe pain in the stroke-affected upper extremity (score \> 6 on 10-point visual analog pain scale), while using the movable wheelchair arm rest device
4. Severe tone at the affected upper extremity (score \> 4 on the Modified Ashworth Spasticity scale)
5. Severe aphasia (score of 2 or higher on the NIH stroke scale - question 9). PI may dismiss this criterion if the participant is deemed able to follow all study instructions.
6. Deficits in vision, language, attention, neglect, or other cognitive functions severe enough to interfere with safe operation of wheelchair or the movable wheelchair arm rest device.
7. Currently pregnant
8. Difficulty in understanding or complying with instructions given by the experimenter.
9. Inability to perform the experimental task that will be studied.
10. Not part of another upper extremity motor-related interventional study

Where this trial is running

Downey, California and 2 other locations

• Rancho Research Institute — Downey, California, United States (RECRUITING)
• University of California Irvine — Orange, California, United States (RECRUITING)
• Casa Colina Hospital and Centers for Healthcare — Pomona, California, United States (RECRUITING)

Study contacts

• Principal investigator: An Do, MD — University of California, Irvine
• Study coordinator: Vicky Chan, PT, DPT

Conditions: Stroke, Cerebral Vascular Accident