Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Kessler Foundation

Status: Enrolling

Conditions: Stroke; Reading Disorder; Aphasia

Treatments: Behavioral: Stretching; Behavioral: Aerobic Exercise Training (AET); Behavioral: Phono-Motor Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06213272

R-1242-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Behavioral: Phono-Motor Therapy

Behavioral: Aerobic Exercise Training (AET)

Stretching and PMT

Active Comparator group

Description:

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.

Treatment:

Behavioral: Phono-Motor Therapy

Behavioral: Stretching