Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Stroke Clinical Trial

Official title:

Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213272
• Other study ID #: R-1242-23
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2024
• Est. completion date: September 30, 2029

Study information

• Verified date: June 2024
• Source: Kessler Foundation
• Contact: Olga Boukrina, PhD
• Phone: 19733243587
• Email: oboukrina[@]kesslerfoundation.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 30, 2029
• Est. primary completion date: September 30, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Dyslexia
• Reading Disorder
• Stroke

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Primary	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.	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Primary	Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)	Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Primary	Cerebral Blood Flow (CBF)	CBF will be measured using an Arterial Spin Labeling MRI sequence	Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
Primary	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.	Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
Primary	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)	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Secondary	Western Aphasia Battery Revised	A comprehensive assessment of language impairments in aphasia	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Secondary	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.	Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)