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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Combined Exercise and Therapy for Post-Stroke Reading Deficits?

Research shows that exercise-based treatments can significantly improve reading fluency and cognitive skills related to literacy in children with reading difficulties. Additionally, oculomotor rehabilitation, which involves eye movement training, has been shown to improve reading abilities in individuals with acquired brain injuries, including stroke. ^{1 2 3 4 5}

Is the combined exercise and therapy treatment for post-stroke reading deficits safe for humans?

The research mentions various therapies like fitness and circuit training, which are generally considered safe for humans when supervised properly. However, specific safety data for the combined exercise and therapy treatment for post-stroke reading deficits is not directly available in the provided studies. ^{1 6 7 8 9}

How is Phono-Motor Therapy different from other treatments for post-stroke reading deficits?

Phono-Motor Therapy is unique because it combines exercises that target both phonological skills (sound-related skills) and motor skills (movement-related skills) to improve reading abilities, which is different from treatments that focus solely on reading practice or physical rehabilitation. ^{1 2 4 10 11}

Research Team

Olga Boukrina, PhD

Principal Investigator

Kessler Foundation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of intensive phonomotor treatment on reading in eight individuals with aphasia and phonological alexia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of an exercise-based treatment for children with reading difficulties. [2007]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Oculomotor rehabilitation for reading in acquired brain injury. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Can treatment for pure alexia improve letter-by-letter reading speed without sacrificing accuracy? [2019]

5. England pubmed.ncbi.nlm.nih.gov

Multimodal therapy of word retrieval disorder due to phonological encoding dysfunction. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Motor speech treatment protocol for developmental motor speech disorders. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Treatment of reading impairment after stroke. [2013]

8. Germany pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Ultrasound biofeedback treatment for persisting childhood apraxia of speech. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

How much exercise does the enhanced gait-oriented physiotherapy provide for chronic stroke patients? [2016]

11. Egypt pubmed.ncbi.nlm.nih.gov

Physical activity in the prevention and treatment of stroke. [2021]