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Randomized Controlled Trial
. 2019 Jul;33(7):523-537.
doi: 10.1177/1545968319846120. Epub 2019 May 25.

Long-Dose Intensive Therapy Is Necessary for Strong, Clinically Significant, Upper Limb Functional Gains and Retained Gains in Severe/Moderate Chronic Stroke

Janis J Daly  1   2 , Jessica P McCabe  3 , John Holcomb  4 , Michelle Monkiewicz  3 , Jennifer Gansen  3 , Svetlana Pundik  3   5
Affiliations
Randomized Controlled Trial

Long-Dose Intensive Therapy Is Necessary for Strong, Clinically Significant, Upper Limb Functional Gains and Retained Gains in Severe/Moderate Chronic Stroke

Janis J Daly et al. Neurorehabil Neural Repair. 2019 Jul.

Abstract

Background. Effective treatment methods are needed for moderate/severely impairment chronic stroke. Objective. The questions were the following: (1) Is there need for long-dose therapy or is there a mid-treatment plateau? (2) Are the observed gains from the prior-studied protocol retained after treatment? Methods. Single-blind, stratified/randomized design, with 3 applied technology treatment groups, combined with motor learning, for long-duration treatment (300 hours of treatment). Measures were Arm Motor Ability Test time and coordination-function (AMAT-T, AMAT-F, respectively), acquired pre-/posttreatment and 3-month follow-up (3moF/U); Fugl-Meyer (FM), acquired similarly with addition of mid-treatment. Findings. There was no group difference in treatment response (P ≥ .16), therefore data were combined for remaining analyses (n = 31; except for FM pre/mid/post, n = 36). Pre-to-Mid-treatment and Mid-to-Posttreatment gains of FM were statistically and clinically significant (P < .0001; 4.7 points and P < .001; 5.1 points, respectively), indicating no plateau at 150 hours and benefit of second half of treatment. From baseline to 3moF/U: (1) FM gains were twice the clinically significant benchmark, (2) AMAT-F gains were greater than clinically significant benchmark, and (3) there was statistically significant improvement in FM (P < .0001); AMAT-F (P < .0001); AMAT-T (P < .0001). These gains indicate retained clinically and statistically significant gains at 3moFU. From posttreatment to 3moF/U, gains on FM were maintained. There were statistically significant gains in AMAT-F (P = .0379) and AMAT-T P = .003.

Keywords: coordination; function; rehabilitation; stroke; upper limb.

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Conflict of interest statement

Declaration of Conflicting Interests: The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.
Figure 1.
Patient flow CONSORT (Consolidated Standards of Reporting Trials) diagram. No adverse events occurred as a result of participation in the study.
Figure 2a.
Figure 2a.
No plateau at mid-treatment indicated by clinically and statistically significant gain in coordination from mid- to posttreatment. *Clinically and statistically significant improvements from pre- to mid- and from mid- to posttreatment, and overall from pre- to posttreatment. The minimum clinically important difference (MCID) for Fugl-Meyer is 4.25.
Figure 2b.
Figure 2b.
Gain in Fugl-Meyer. *N = 36; other comparisons, N = 31. †P < .0001. І = standard error.
Figure 3a.
Figure 3a.
Arm Motor Ability Test Function (AMAT-F) clinically and statistically significant improvement from pre-treatment to follow-up. *Clinically and statistically significant gain from pretreatment to follow-up. Minimum clinically important change for AMAT-F is 0.44 points. Statistically significant gain from posttreatment to follow-up.
Figure 3b.
Figure 3b.
Gain in Arm Motor Ability Test Function (AMAT-F). *P < .0001. †P = .0379. І, standard error.
Figure 4a.
Figure 4a.
Arm Motor Ability Test Time (AMAT-T) statistically significant improvement from pre- to posttreatment and from posttreatment to follow-up. *Statistically significant improvement (P < .05).
Figure 4b.
Figure 4b.
Gain in Arm Motor Ability Test Time (AMAT-T). *P < .0001. †P = .0003. І, standard error.
See this image and copyright information in PMC

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