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Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06213272
Enrollment
70
Registered
2024-01-19
Start date
2024-04-18
Completion date
2029-03-01
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphasia, Reading Disorder, Stroke

Keywords

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

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.

Interventions

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.

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

BEHAVIORALStretching

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

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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)
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.
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.

Secondary

MeasureTime frameDescription
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.
Western Aphasia Battery RevisedBaseline and within 2 weeks of treatment completion (~10 weeks from study onset)A comprehensive assessment of language impairments in aphasia

Countries

United States

Contacts

Primary ContactOlga Boukrina, PhD
oboukrina@kesslerfoundation.org19733243587
Backup ContactMatthew R Weiner
mweiner@kesslerfoundation.org973-323-3745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026