Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
This study is testing a new way to help people with reading difficulties (reading deficits) after a stroke. It combines a special reading treatment called Phono-Motor Therapy (PMT) with either aerobic exercise (like cycling) or light stretching. The goal is to see if adding exercise can improve reading and language skills more than PMT alone. Researchers believe exercise might increase blood flow to the brain, helping to repair damaged areas. You might be able to join if you are 18-85 years old, had your first stroke more than three months ago, have reading difficulties, and live within 50 miles of Kessler Foundation. The study will measure reading aloud, computer tasks, and reading comprehension to see if the treatments are successful. The current status of this study is unclear.
- Study design
- This is an interventional, randomized controlled trial planning to enroll 70 participants.
- What's involved
- You would complete 40 sessions of treatment, along with three MRI scans and behavioral tests before and after the intervention.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your reading abilities will be measured within two weeks of completing treatment, which is about 10 weeks from the start of the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
At a glance
Conditions
NCT06213272
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Kessler Foundation
West Orange, New Jerseystudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Olga Boukrina · PRINCIPAL_INVESTIGATOR · Kessler Foundation
Who to contact
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Inclusion
Exclusion
What this trial measures
- Reading AloudBaseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Participants will read aloud 120 words and 80 nonwords, some of which will be selected for PMT based on individual accuracy (treated items). A subset of these will not be treated and will be used to assess generalization.
- 2 Alternative Forced Choice Computer TasksBaseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Touch-screen computer tests of semantics, phonology, \& orthography (composite score). Participants choose one of two examples on the screen that matches a target in meaning (semantics), rhymes with the target (phonology), or chose a letter string that more closely resembles a word.
- Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.
- Cerebral Blood Flow (CBF)Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
CBF will be measured using an Arterial Spin Labeling MRI sequence
- Resting State Functional Connectivity (rsFC)Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
RsFC will be measured using fMRI acquired with rapid simultaneous multi-slice echo-planar imaging (EPI) (TR=1.5s, TE=30ms, 44 slices, gap = .5mm, 2mm isotropic voxels, N volumes=400, eyes open). To standardize the rest condition across participants, we will instruct participants to look at a centrally presented fixation dot for the duration of the scan.
- Task-induced fMRI activationBaseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Data will be collected using fMRI sequence above. Participants will perform a reading aloud task where words or nonwords are presented on the screen one at a time. The order of reading blocks (words/nonwords) will be randomized (9 blocks of each\*2 runs). Each 32 s reading block will have 8 words (blocked by condition, e.g., high imagery, frequency, and consistency) or nonwords, presented for 1 s and followed by \~3s response period. The onset of each word or nonword stimulus will be randomly jittered by 100-400ms to provide the ability to model errors. Voice responses will be collected via an MR microphone (FOMRI III+, Optoacoustics) and used to score reading accuracy. Reading aloud accuracy will be evaluated by 2 independent raters, and disagreements will be resolved by discussion. The reading aloud blocks will be alternated with baseline fixation blocks (12s) and rest blocks (8s) for a total duration of 52s for each block cycle (7.8 min run)