Combined Exercise and Therapy for Post-Stroke Reading Deficits

Overseen By Matthew R Weiner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Neurological disease, Dyslexia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

Duration: 8-10 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat reading difficulties experienced by some stroke survivors. It combines aerobic exercise with Phono-Motor Therapy (PMT), a therapy focused on improving reading and language skills. Participants will engage in either aerobic exercise or stretching before starting PMT in each session. The trial seeks individuals who had their first stroke more than three months ago, have trouble reading, and live within 50 miles of the Kessler Foundation. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery options for stroke survivors.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this combined exercise and therapy approach is safe for post-stroke reading deficits?

A previous study found aerobic exercise safe for people who have had a stroke. It suggests that combining aerobic and strength training can improve thinking skills without major risks. Similarly, a detailed review of physical therapy methods has shown that stretching exercises are safe and helpful for stroke recovery.

For Phono-Motor Therapy, research shows it is well-tolerated by stroke patients. Studies have examined its role in improving reading skills after a stroke, and no major negative effects have been reported. Overall, current research indicates that combining aerobic exercise or stretching with Phono-Motor Therapy is safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combined exercise and therapy approach for post-stroke reading deficits because it introduces a novel blend of physical and cognitive rehabilitation. Unlike traditional treatments that mainly focus on cognitive therapy alone, this method incorporates aerobic exercise or stretching with Phono-Motor Therapy (PMT), aiming to enhance brain function through increased blood flow and neural engagement. This dual approach not only addresses reading deficits but also promotes overall physical health, potentially leading to more holistic recovery outcomes. By integrating physical activity with targeted cognitive exercises, researchers hope to discover more effective ways to improve post-stroke rehabilitation.

What evidence suggests that this trial's treatments could be effective for post-stroke reading deficits?

This trial will compare two treatment combinations for post-stroke reading deficits. Research has shown that combining aerobic exercise with phono-motor therapy can significantly enhance reading and language skills in individuals with post-stroke reading difficulties. Participants in one arm of this trial will receive Aerobic Exercise Training (AET) combined with Phono-Motor Therapy (PMT). Studies have found that aerobic exercise enhances brain function and language skills, which is particularly beneficial for stroke recovery. Phono-motor therapy, focusing on sounds and movement, helps rebuild brain connections related to reading.

Participants in another arm will receive Stretching combined with PMT. While some studies found only small improvements in reading comprehension for groups, certain individuals demonstrated positive changes. Together, these treatments aim to improve blood flow in the brain and repair damaged reading networks, offering a promising approach to enhancing reading abilities after a stroke. ^{6 7 8 9 10}

Who Is on the Research Team?

Olga Boukrina, PhD

Principal Investigator

Kessler Foundation

Are You a Good Fit for This Trial?

This trial is for right-handed individuals who were fluent in English and literate before their first-ever stroke, which occurred over 3 months ago. They must have reading deficits as defined by specific accuracy percentages for words and nonwords, be cleared for exercise by a physician, and live within 50 miles of the Kessler Foundation. People with MRI contraindications, prior neurological diseases, or those currently undergoing speech therapy cannot participate.

Inclusion Criteria

Fluent and literate in English prior to stroke

I have had my first stroke.

Reading deficits, defined as reading aloud accuracy <83% for single words or <65% for readable nonwords

Exclusion Criteria

Contraindication to MRI

I have had a neurological disease before.

Contraindication to exercise

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 40 sessions of targeted reading treatment combined with either aerobic exercise or stretching

8-10 weeks

40 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

MRI and Behavioral Testing

Participants undergo MRI scans and complete behavioral testing before and after the intervention

Throughout the study

What Are the Treatments Tested in This Trial?

Interventions

• Aerobic Exercise Training (AET)
• Phono-Motor Therapy
• Stretching

Trial Overview

The study tests a new treatment method combining physical exercises (stretching and aerobic training) with Phono-Motor Therapy to improve reading abilities after a stroke. The goal is to boost brain circulation and repair damaged language networks through this dual approach.

How Is the Trial Designed?

Group I: Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT) Experimental Treatment 2 Interventions

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.

Group II: Stretching and PMT Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Published Research Related to This Trial

In a study involving 20 chronic stroke patients, a three-week gait-oriented physiotherapy program provided a total of 19 hours of instructed therapy and 28 hours of self-initiated training, emphasizing the importance of active practice in rehabilitation.

The combination of various training methods, including electromechanical gait trainers and self-initiated exercises, led to significant improvements in gait ability, highlighting the effectiveness of structured and diverse rehabilitation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? Peurala, SH., Pitkänen, K., Sivenius, J., et al.[2016]

The Motor Speech Treatment Protocol (MSTP) showed significant improvements in speech accuracy for five children with severe to profound speech sound disorders, indicating its potential effectiveness in enhancing speech motor control.

All participants, except one, demonstrated positive changes in both practiced and untrained words, suggesting that the MSTP not only helps with targeted speech sounds but also promotes generalization to other words.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motor speech treatment protocol for developmental motor speech disorders. Namasivayam, A., Pukonen, M., Hard, J., et al.[2018]

Constraint-induced movement therapy and Botulinum toxin type A are the most effective treatments for motor rehabilitation in stroke patients with focal spasticity, based on evidence from randomized controlled trials and systematic reviews.

Other effective interventions include serotonin re-uptake inhibitors, L-dopa, mirror therapy, virtual reality, and electromechanical devices for walking, while therapies like bilateral arm training and robot-assisted arm therapy did not show significant benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence-based methods in motor rehabilitation after stroke]. Liepert, J.[2022]

An exercise-based program called DDAT significantly improved various skills related to literacy in 35 children at a Warwickshire junior school, including reading fluency and phonological skills, after six months of daily home practice.

The intervention group showed substantial improvements in balance, dexterity, and cognitive skills compared to a control group, indicating that physical exercise can positively impact literacy outcomes for children at risk of dyslexia and related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of an exercise-based treatment for children with reading difficulties. Reynolds, D., Nicolson, RI., Hambly, H.[2007]

The experimental treatment for a patient with pure alexia involved a two-stage approach that first improved reading accuracy through tactile-kinesthetic strategies, followed by a focus on increasing reading speed.

After the treatment, the patient demonstrated significant improvements in both accuracy and speed when reading trained and untrained words, as well as at the sentence level.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can treatment for pure alexia improve letter-by-letter reading speed without sacrificing accuracy? Nitzberg Lott, S., Friedman, RB.[2019]

The study involved 6 children aged 9-15 years who underwent 18 treatment sessions using ultrasound biofeedback to improve speech sound accuracy related to childhood apraxia of speech (CAS).

All participants achieved at least 80% accuracy on treated sound sequences, with significant improvements maintained for 2 months post-treatment, indicating that ultrasound biofeedback is an effective method for addressing speech sound errors in children with CAS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback treatment for persisting childhood apraxia of speech. Preston, JL., Brick, N., Landi, N.[2022]

A multimodal treatment called phonomotor treatment significantly improved phonological processing and oral reading abilities in 8 individuals with phonological alexia after 60 hours of therapy over 6 weeks, with improvements maintained 3 months later.

While overall reading comprehension did not show group improvement, one participant did demonstrate gains, suggesting that individual responses to treatment can vary and may depend on specific factors like treatment intensity and severity of alexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intensive phonomotor treatment on reading in eight individuals with aphasia and phonological alexia. Brookshire, CE., Conway, T., Pompon, RH., et al.[2022]

In a study involving 14 adults with acquired brain injuries (5 with stroke and 9 with traumatic brain injury), an 8-week oculomotor rehabilitation program significantly improved reading abilities, as confirmed by both objective eye movement recordings and subjective questionnaires.

The combination of visual and auditory feedback during training appeared to enhance the effectiveness of the rehabilitation, suggesting that integrating multiple feedback types may lead to better outcomes in reading-related oculomotor rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oculomotor rehabilitation for reading in acquired brain injury. Ciuffreda, KJ., Han, Y., Kapoor, N., et al.[2016]

Phonological multimodal therapy significantly improved verbal naming abilities in a 52-year-old woman with a lexical phonological naming disorder, with results showing improvement for both trained and untrained words (p < 0.001).

The improvements in naming were maintained for at least 3 months post-therapy, and there was also a notable enhancement in daily communication (p < 0.05), indicating the therapy's effectiveness and potential for real-life application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multimodal therapy of word retrieval disorder due to phonological encoding dysfunction. Weill-Chounlamountry, A., Capelle, N., Tessier, C., et al.[2019]

Physical activity plays a crucial role in both preventing strokes and aiding recovery in stroke survivors, with a growing body of evidence supporting its effectiveness in rehabilitation.

The review highlights the importance of considering factors like gender and exercise intensity when prescribing physical activity, and it calls for more research to optimize exercise guidelines for stroke prevention and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity in the prevention and treatment of stroke. Gallanagh, S., Quinn, TJ., Alexander, J., et al.[2021]

Acquired alexia, a reading impairment following stroke, is increasingly understood, leading to targeted rehabilitation therapies that focus on specific types of alexia, such as improving reading eye movements in hemianopic alexia and enhancing whole-word recognition in pure alexia.

Despite advancements in therapy, most studies remain descriptive and based on single cases, highlighting the need for more systematic research to establish effective rehabilitation strategies for the diverse disorders associated with acquired alexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of reading impairment after stroke. Leff, AP., Behrmann, M.[2013]

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