Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

NCT06213272 | Recruiting DMC

• 1 other identifier: R-1242-23
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Aphasia; Reading Disorder

Keywords

exercise; stroke; aphasia; reading therapy; phono-motor therapy; aerobic exercise treatment; MRI

Outcome Measures

Primary Outcomes (6)

• Reading Aloud

  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.

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

• 2 Alternative Forced Choice Computer Tasks

  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.

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

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

  Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.

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

• Cerebral Blood Flow (CBF)

  CBF will be measured using an Arterial Spin Labeling MRI sequence

  Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)

• Resting State Functional Connectivity (rsFC)

  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.

  Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)

• Task-induced fMRI activation

  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)

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

Secondary Outcomes (2)

• Western Aphasia Battery Revised

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

• Philadelphia Naming Test (Short)

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

Study Arms (2)

Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT)

EXPERIMENTAL

Patients will receive 40, once-daily 2-hour intervention sessions administered 4-5 times per week by trained research assistants. Sessions will begin with a 5-min warm-up, followed by 20 min of aerobic exercise (cycling, 60% heart rate range), and a 5-min cool-down. Participants will rate their perceived effort every 5 minutes and complete a log at the end of each session to characterize their experience. When HR returns to near resting levels (i.e., 5-min after cool-down), participants will undertake the PMT for the remaining 90 min.

Behavioral: Phono-Motor Therapy; Behavioral: Aerobic Exercise Training (AET)

Stretching and PMT

ACTIVE COMPARATOR

Patients will receive 40, once-daily 2-hour intervention sessions administered 4-5 times per week by trained research assistants. Sessions will begin with a 5-min warm-up, followed by 20 min of stretching and a 5-min cool-down. Stretching activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot. Participants will complete a log at the end of each session to characterize their experience, and within 5 min of completing the last stretching activity, participants will undertake PMT for the remaining 90 min of a given session.

Behavioral: Phono-Motor Therapy; Behavioral: Stretching

Interventions

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 Treatment (AET) combined with Phono-Motor Therapy (PMT); Stretching and PMT

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.

Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT)

Stretching BEHAVIORAL

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

Stretching and PMT

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• fluent and literate in English prior to stroke
• st 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.

You may not qualify if:

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

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Aphasia; Dyslexia; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Olga Boukrina

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Boukrina, PhD

CONTACT

19733243587; oboukrina@kesslerfoundation.org

Matthew R Weiner

CONTACT

973-323-3745; mweiner@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants will not be informed about study hypotheses. Outcome Assessors will be masked to participants' assigned condition. Treating therapists (care providers) will be masked to participants baseline and outcome scores.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Model Details: Participants will be randomly assigned to one of the 2 intervention groups: combined aerobic exercise and phono-motor therapy, or combined light stretching and phono-motor therapy. Randomization will be stratified by aphasia severity.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 19, 2024
• Study Start: April 18, 2024
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE
• Time Frame: Data sharing will occur no later than the time of an associated publication of primary study outcomes or 1 year from the end of the performance period, whichever comes first. Data stored in repositories such as OpenNeuro.org, GitHub, and ClinicalTrials.gov are typically retained long term, often without a predetermined deletion date. Therefore, barring any unforeseen changes to these platforms' policies, the data from this project will be available for an indefinite period of time, allowing scientific community to access and utilize the available information.
• Access Criteria: Access to the scientific data will require users to create an account with the respective repository (GitHub or OpenNeuro.org). After this step, they will be able to freely access and use the data, following the repository's terms of use. Study design data, which will be hosted on ClinicalTrials.gov, will be available to users without registration.

Locations

US (1)