Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Not Applicable

Recruiting

• Conditions: Aphasia; Stroke; Reading Disorder

• Registration Number: NCT06213272
• Lead Sponsor: Kessler Foundation

Brief Summary

The goal of the proposed project is to test the effectiveness of a novel hybrid approach to treatment of reading disorders after stroke, in which exercise training will be used in combination with a targeted reading treatment. This approach is expected to increase cerebral circulation and help to rebuild and strengthen the damaged phonological neural networks. Through this combinatory approach, the study aims to enhance the reading and language improvements seen with existing treatments.

Detailed Description

Close to 2.5 million Americans are currently living with post-stroke aphasia, a debilitating communication disorder affecting multiple language modalities. Most stroke survivors with aphasia have acquired reading deficits, which persist chronically and severely limit life participation and autonomy. There is an urgent need for effective treatments grounded in stroke neurobiology which yield robust functional improvements. This project is a randomized controlled trial, which will recruit 70 individuals with chronic left-hemisphere stroke. Participants will complete 40 sessions of targeted reading treatment combined with either 20 minutes of moderate aerobic exercise or light stretching. Participants will undergo 3 Magnetic Resonance Imaging (MRI) scans, administered before the intervention, after the initial exercise session, and after the full course of treatment. They will also complete behavioral testing before and after the intervention. The outcome of this study has the potential to radically change how reading treatments are applied, increasing their effectiveness, and ultimately improving the lives of 2.5 million Americans living with stroke-related aphasia. In addition, it is likely that the results will contribute to the understanding of stroke recovery mechanisms thereby fundamentally advancing the field of neurorehabilitation.

Study Timeline

• Study First Submitted: 2023-12-26
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-19
• Study Start: 2024-04-18
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2029-03-01
• Study Completion: 2029-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• fluent and literate in English prior to stroke
• 1st ever stroke
• more than 3 months post-stroke
• post-stroke reading deficits, defined as reading aloud accuracy <83% for single words or <65% for readable nonwords
• living within a 50-mile radius from Kessler Foundation.

Exclusion Criteria

• contraindication to MRI
• prior neurological disease
• developmental learning or reading disability (i.e., developmental dyslexia)
• contraindication to exercise
• concurrent speech and language therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reading Aloud	Baseline 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 Tasks	Baseline 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.
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
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.
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 activation	Baseline 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)

Secondary Outcome Measures

Name	Time	Method
Western Aphasia Battery Revised	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)	A comprehensive assessment of language impairments in aphasia
Philadelphia Naming Test (Short)	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)	A 30-tem picture naming test designed to identify word finding difficulties. It is presented on a computer using line drawn images of animate and inanimate objects and is audio recorded.

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 West Orange, New Jersey, United States