Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorKessler Foundation
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
contraindication to MRI
prior neurological disease
developmental learning or reading disability (i.e., developmental dyslexia)
contraindication to exercise
Trial design
Design model
Parallel
Treatments tested in this trial
Phono-Motor Therapy
BehavioralThe 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)
BehavioralStationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down.
Stretching
BehavioralLight stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Aerobic Exercise Treatment (AET) combined with Phono-Motor Therapy (PMT)Experimental treatment 2 interventions
Group B: Stretching and PMTActive comparator 2 interventions
Trial outcomes
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)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)Sponsors and contacts
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Source ClinicalTrials.gov