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NCT Number: NCT06213272

Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

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.

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Key information

Conditions

Stroke Aphasia Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Communication Disorders Dyslexia Language Disorders Learning Disabilities Mental Disorders Motor Activity Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Reading Disorder Signs and Symptoms Specific Learning Disorder Speech Disorders Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location status: Recruiting

Location contact

Olga Boukrina, Ph.D.

CONTACT

[email protected]

9733243587

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phono-Motor Therapy

Behavioral

The goal of PMT is to build orthographic and phonological awareness and phonological sequence knowledge. During PMT, participants will complete a series of tasks manipulating minimal sound units (consonants (C) & vowels (V)), combining these units into syllables (CVC, CVCC, CCVC) and syllable sequences (real words and readable nonwords). PMT will aim to engage 5 modalities: visual, acoustic, tactile kinesthetic, motor, and orthographic. Multisyllabic stimuli used during treatment will consist of 40 real words and 68 readable nonword letter strings.

Aerobic Exercise Training (AET)

Behavioral

Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down.

Stretching

Behavioral

Light stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.

Primary outcomes

  1. Reading Aloud

    Time frame: 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. 2 Alternative Forced Choice Computer Tasks

    Time frame: 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.

  3. Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)

    Time frame: 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.

  4. Cerebral Blood Flow (CBF)

    Time frame: 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

  5. Resting State Functional Connectivity (rsFC)

    Time frame: 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.

  6. Task-induced fMRI activation

    Time frame: 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 outcomes

  1. Western Aphasia Battery Revised

    Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

    A comprehensive assessment of language impairments in aphasia

  2. Philadelphia Naming Test (Short)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Matthew R Weiner

CONTACT

[email protected]

973-323-3745

Olga Boukrina, PhD

CONTACT

[email protected]

19733243587

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jan 19, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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