Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Browse trials for

• Stroke 8,255
• Aphasia 338
• Dyslexia 127
• Motor Activity 9,798

Keywords

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

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 70 is above the median of 49 across 6,024 interventional studies indexed under Stroke.

Lead sponsor

Kessler Foundation is the lead sponsor of 175 studies on the registry; 61 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study 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.

  Behavioral: Phono-Motor Therapy · Behavioral: Aerobic Exercise Training (AET)

• 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.

  Behavioral: Phono-Motor Therapy · Behavioral: Stretching

Interventions

• BehavioralPhono-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.

• BehavioralAerobic Exercise Training (AET)

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

• BehavioralStretching

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

Primary outcomes

1. 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.

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

2. 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.

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

3. Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)

   Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

4. Cerebral Blood Flow (CBF)

   CBF will be measured using an Arterial Spin Labeling MRI sequence

   Time frame: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)

5. 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.

   Time frame: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)

6. 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)

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

Secondary outcomes

1. Western Aphasia Battery Revised

   A comprehensive assessment of language impairments in aphasia

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

2. 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.

   Time frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)

Individual participant data

Plan to share: Yes — The scientific data and metadata generated by this project will be securely archived in several repositories. Our study design will be hosted on ClinicalTrials.gov, the code will be stored on GitHub, and the neuroimaging data alongside behavioral datasets will be deposited on OpenNeuro.org. Each repository will contain links to the others, ensuring seamless accessibility and discoverability of all associated data and metadata across the platforms.

Supporting information: Study protocol, Clinical study report, Analytic code

Time frame: Data sharing will occur no later than the time of an associated publication of primary study outcomes or 1 year from the end of the performance period, whichever comes first. Data stored in repositories such as OpenNeuro.org, GitHub, and ClinicalTrials.gov are typically retained long term, often without a predetermined deletion date. Therefore, barring any unforeseen changes to these platforms' policies, the data from this project will be available for an indefinite period of time, allowing scientific community to access and utilize the available information.

Access criteria: Access to the scientific data will require users to create an account with the respective repository (GitHub or OpenNeuro.org). After this step, they will be able to freely access and use the data, following the repository's terms of use. Study design data, which will be hosted on ClinicalTrials.gov, will be available to users without registration.

Data sharing details ↗ · openneuro.org