StrokeNCT06213272
Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
A study testing Phono-Motor Therapy, Aerobic Exercise Training (AET) and Stretching in people with Stroke and Aphasia, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Aphasia, Reading Disorder
- What is being tested?
- Phono-Motor Therapy, Aerobic Exercise Training (AET) and Stretching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2024to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- contraindication to MRI
- prior neurological disease
- developmental learning or reading disability (i.e., developmental dyslexia)
- contraindication to exercise
- concurrent speech and language therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
West Orange, New Jersey, 07052
Olga Boukrina, Ph.D., 9733243587, oboukrina@kesslerfoundation.org
About this study
Official title: Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment
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.
Read the 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.
- Conditions
- Stroke, Aphasia, Reading Disorder
- Being tested
- Phono-Motor Therapy, Aerobic Exercise Training (AET), Stretching
- Keywords
- exercise, stroke, aphasia, reading therapy, phono-motor therapy, aerobic exercise treatment, MRI
- Medical subject headings
- Stroke, Aphasia, Dyslexia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phono-Motor TherapyBehavioural
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)Behavioural
Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down.
StretchingBehavioural
Light stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Phono-Motor Therapy; Behavioral: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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)
Measured: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Secondary outcomes (2)
Western Aphasia Battery Revised
A comprehensive assessment of language impairments in aphasia
Measured: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Philadelphia Naming Test (Short)
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.
Measured: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start18 Apr 2024
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olga Boukrina, Kessler Foundation
- Investigators
- Olga Boukrina, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06213272
- Sponsor's protocol ID
- R-1242-23
- Status last verified
- Aug 2026
- First submitted
- 26 Dec 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The scientific data and metadata generated by this project will be securely archived in several repositories. Our study design will be hosted on ClinicalTrials.gov, the code will be stored on GitHub, and the neuroimaging data alongside behavioral datasets will be deposited on OpenNeuro.org. Each repository will contain links to the others, ensuring seamless accessibility and discoverability of all associated data and metadata across the platforms.
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment
- ClinicalTrials.gov ID
- NCT06213272
- Acronym / sponsor ID
- R-1242-23
- Conditions
- Stroke, Aphasia, Reading Disorder
- Keywords
- exercise, stroke, aphasia, reading therapy, phono-motor therapy, aerobic exercise treatment, MRI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT) | Experimental | Behavioral: Phono-Motor Therapy, Behavioral: Aerobic Exercise Training (AET)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. |
| Stretching and PMT | Active comparator | Behavioral: Phono-Motor Therapy, Behavioral: StretchingPatients 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- contraindication to MRI
- prior neurological disease
- developmental learning or reading disability (i.e., developmental dyslexia)
- contraindication to exercise
- concurrent speech and language therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phono-Motor TherapyThe 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. | Behavioural | Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT), Stretching and PMT |
| Aerobic Exercise Training (AET)Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down. | Behavioural | Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT) |
| StretchingLight stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot. | Behavioural | Stretching and PMT |
Primary outcome
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 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.
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.
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
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.
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)
2 secondary outcomes
Western Aphasia Battery Revised
Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Philadelphia Naming Test (Short)
Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: Yes. The scientific data and metadata generated by this project will be securely archived in several repositories. Our study design will be hosted on ClinicalTrials.gov, the code will be stored on GitHub, and the neuroimaging data alongside behavioral datasets will be deposited on OpenNeuro.org. Each repository will contain links to the others, ensuring seamless accessibility and discoverability of all associated data and metadata across the platforms.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olga Boukrina principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phono-Motor Therapy, Aerobic Exercise Training (AET) and Stretching in people with Stroke and Aphasia, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olga Boukrina, PhD (19733243587, oboukrina@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading Aloud (time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.