Improving Reading Competence in Aphasia With Combined Aerobic Exercise and Phono-Motor Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants will not be informed about study hypotheses. Outcome Assessors will be masked to participants' assigned condition. Treating therapists (care providers) will be masked to participants baseline and outcome scores.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •contraindication to MRI
- •prior neurological disease
- •developmental learning or reading disability (i.e., developmental dyslexia)
- •contraindication to exercise
- •concurrent speech and language therapy
研究组 & 干预措施
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.
干预措施: Phono-Motor Therapy (Behavioral)
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.
干预措施: Aerobic Exercise Training (AET) (Behavioral)
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.
干预措施: Phono-Motor Therapy (Behavioral)
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.
干预措施: Stretching (Behavioral)
结局指标
主要结局
Reading Comprehension Battery for Aphasia - 2nd edition (RCBA-2)
时间窗: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
Letter, word, sentence, paragraph, and text-level reading comprehension test for aphasia.
Reading Aloud
时间窗: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
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.
2 Alternative Forced Choice Computer Tasks
时间窗: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
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.
Cerebral Blood Flow (CBF)
时间窗: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
CBF will be measured using an Arterial Spin Labeling MRI sequence
Resting State Functional Connectivity (rsFC)
时间窗: Baseline, after a single session of acute exercise, and within 2 weeks of treatment completion (~10 weeks from study onset)
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.
Task-induced fMRI activation
时间窗: Baseline and within 2 weeks of treatment completion (~10 weeks from study onset)
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)
次要结局
- Philadelphia Naming Test (Short)(Baseline and within 2 weeks of treatment completion (~10 weeks from study onset))
- Western Aphasia Battery Revised(Baseline and within 2 weeks of treatment completion (~10 weeks from study onset))
研究者
Olga Boukrina
Research Scientist
Kessler Foundation