Combined Exercise and Targeted Therapy for Post-Stroke Reading Deficits

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06213272
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Phono-Motor Therapy — BEHAVIORAL
    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) — BEHAVIORAL
    Stationary ergometer cycling at 60% heart rate range for 20 minutes, plus 5 minutes of warm up and cool down.
  • Stretching — BEHAVIORAL
    Light stretching activities targeting the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, ankle/foot.

Study Details

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.

Key Dates

Start date
Apr 18, 2024
Status verified
May 2025
Primary completion
Mar 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.
  • 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.

Primary Outcome Measure

Reading Aloud [ Time Frame: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Olga Boukrina, Ph.D.
[email protected]
9733243587

Find similar trials in West Orange, NJ

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Kessler Foundation· West Orange, NJ

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