PRALINE: study protocol for a phase IIb inpatient stroke rehabilitation randomized controlled trial investigating longitudinal outcomes after progressive abduction loading therapy
Bibliographic record
Abstract
BACKGROUND: Stroke is the leading cause of long-term disability with paucity of evidence-based interventions for individuals with severe upper extremity impairment in the affected arm. Loss of independent joint control limits reaching distance and velocity contributing to activity and participation limitations. Emerging evidence demonstrates improved independent upper extremity joint movement with training combining shoulder abduction loading during high repetition, task-specific reaching practice. The purpose of this study is to compare outcomes for one-year post-stroke for participants who receive reaching training with vs without progressive shoulder abduction loading during upper extremity reaching training using a standardized mechantronic device. METHODS: This is a phase II, double-blinded randomized clinical trial conducted at two inpatient rehabilitation hospitals. Eighty-six individuals will be recruited upon admission to acute inpatient rehabilitation and randomly allocated to either the experimental or active comparator intervention groups. Both groups will receive reaching training with the affected upper extremity in a standardized mechatronic device 4 days per week while in inpatient or day rehabilitation. Outcomes will be assessed at baseline, weekly while in inpatient and day rehabilitation, and every other month after discharge until one year post-stroke. Primary outcomes include change in reaching function of the affected upper extremity, measured by kinematic evaluation. This captures the loss of independent joint control due to flexion synergy expression. Secondary outcomes include measures of severity of flexion synergy motor impairment, Action Research Arm Test, Fugl-Meyer Assessment, and the Stroke Impact Scale. DISCUSSION: This study will test the efficacy of progressive shoulder abduction loading during reaching training using a mechatronic device. The results of this study have the potential to inform clinical practice for upper extremity reaching training for individuals with severe upper extremity impairment post-stroke to reduce flexion synergy expression. TRIAL REGISTRATION: Clinicaltrials.gov, NCT04118998. Registered on 8 October 2019.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.032 | 0.035 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.012 | 0.005 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.004 | 0.003 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.004 | 0.002 |
| Research integrity | 0.007 | 0.009 |
| Insufficient payload (model declined to judge) | 0.137 | 0.023 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".