Recruiting

Combined Exercise

Sponsor:

Kessler Foundation

Code:

NCT06213272

Conditions

Stroke

Aphasia

Reading Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Phono-Motor Therapy

Aerobic Exercise Training (AET)

Stretching

Study Details

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

Study ID

NCT06213272

Start date

Apr 18, 2024

Status verified date

Aug, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

active comparator: Stretching and PMT

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.

Interventions

Phono-Motor Therapy

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)

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

Stretching

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

Primary outcome measure

  • Reading Aloud [ Time Frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset) ]
  • 2 Alternative Forced Choice Computer Tasks [ Time Frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset) ]
  • Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2) [ Time Frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset) ]
  • 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) ]
  • 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) ]
  • Task-induced fMRI activation [ Time Frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset) ]

Central Contacts and Locations

Central contacts

Olga Boukrina, PhD

19733243587oboukrina@kesslerfoundation.org

Matthew R Weiner

973-323-3745mweiner@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Olga Boukrina, Ph.D.

9733243587oboukrina@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2026-08-13.