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Does More Practice Improve Arm Movement After Stroke?

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ClinicalTrials.gov Identifier: NCT01146379
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : February 24, 2017
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Catherine E. Lang, Washington University School of Medicine

June 3, 2010
June 17, 2010
October 31, 2016
February 24, 2017
February 24, 2017
May 2010
October 2015   (Final data collection date for primary outcome measure)
Change in Action Research Arm Test (ARAT) Score Per Week [ Time Frame: 9 weeks ]
The Action Research Arm Test (ARAT) is a standardized assessment of upper extremity functional capacity. Criterion scores are awarded by a trained assessor as the person performs 19 different items requiring reaching, grasping, and manipulation of various objects. Maximum total score is 57. Minimum total score is 0. Higher scores represent better arm and hand functional capacity. In this study, scores were assesses weekly and the analysis evaluated the rate of change over time in units/week.
Action Research Arm Test (ARAT) [ Time Frame: 9 weeks ]
Standardized assessment of upper extremity function
Complete list of historical versions of study NCT01146379 on ClinicalTrials.gov Archive Site
Not Provided
  • Motricity Index [ Time Frame: 9 weeks ]
    Impairment scale measuring upper extremity strength
  • Stroke Impact Scale [ Time Frame: 9 weeks ]
    Questionnaire measuring self-perception of upper extremity function
  • Motor Activity Log [ Time Frame: 9 weeks ]
    Questionnaire measuring self-perception of how the upper extremity is used to participate in everyday life
Not Provided
Not Provided
 
Does More Practice Improve Arm Movement After Stroke?
Dose Response of Movement Practice During Stroke Rehabilitation
Arm weakness happens a lot after a stroke. People often get physical or occupational therapy after their stroke to learn how to use their arm again. This study will help figure out how much therapy should be given to restore as much arm function as possible.

Dose has emerged as a key factor promoting functional recovery after stroke. Currently, a lack of data on the dose-response relationship impedes progress in the field of stroke rehabilitation. The goal of the proposed project is to define the range of doses of movement practice that produce the greatest improvements in outcomes in people with chronic stroke. Borrowing from animal models of stroke, dose in humans can be quantified by the number of repetitions of task-specific practice.

Our central hypothesis is that there exists a range of doses for people with stroke, below which, there is minimal benefit, and above which, further practice does not result in further benefit. The range of beneficial doses is likely to vary based on the severity of motor deficits and the presence of non-motor deficits in other domains. Using a randomized, parallel dose-response design, we will evaluate the benefits of four different doses of task-specific upper extremity training with matched schedules of 1 hr sessions, 4 sessions/wk for 8 wks, in 100 people with chronic stroke. Total repetition doses to be evaluated (3200, 6400, 9600, & individualized-maximum) are based on our preliminary data. The individualized-maximum group may extend their sessions beyond 8 wks until meeting defined stop criteria.

Our primary aim will test whether larger total doses result in better outcomes than smaller total doses. Benefits of the four doses will be evaluated at the impairment, activity, and participation levels, since understanding the dose-response relationship at all levels of measurement is critical for advancing rehabilitation research. We hypothesize that improvements will be greatest in the 9600 and individualized-maximum, followed by the 6400, and then the 3200 repetition dose groups. Our secondary aim is to characterize the dose-response relationship of upper extremity task-specific practice. With data from multiple assessment points, individual curve modeling will be used to estimate dose ranges, below which, there is minimal benefit, and above which, further practice does not result in further benefit. Furthermore, we will determine how various factors modify the dose estimates. We hypothesize that the severity of motor deficits will be the primary modifier of the dose-response relationship, with larger doses needed for those with more mild motor deficits. We further expect that needed doses will be larger for those with depression and hemispatial neglect.

Our team is well-positioned to investigate the critical issue of dose because of our expertise in stroke rehabilitation research and measurement, our understanding of the challenges of clinical practice and clinical research, and our ready access to this patient population. Expected outcomes from this project are empirically-driven estimates indicating the amount of movement practice required to drive maximal improvements and how these estimates can be individually modified for people undergoing stroke rehabilitation. Our estimates will immediately impact rehabilitation research and clinical practice. The importance of this project transcends stroke rehabilitation; our primary results will be of high value to many other rehabilitation populations also impeded by the lack of knowledge regarding dose-response relationships.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
Other: Intensive task-specific upper extremity rehabilitation
The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
  • Experimental: Low Movement Dose, 3200 total reps
    he experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
    Intervention: Other: Intensive task-specific upper extremity rehabilitation
  • Experimental: Medium Movement Dose, 6400 total reps
    he experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
    Intervention: Other: Intensive task-specific upper extremity rehabilitation
  • Experimental: High Movement Dose, 9600 total reps
    he experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
    Intervention: Other: Intensive task-specific upper extremity rehabilitation
  • Experimental: Individual Maximum High Movement Dose
    he experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
    Intervention: Other: Intensive task-specific upper extremity rehabilitation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
85
100
October 2015
October 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ischemic or hemorrhagic stroke as determined by a stroke neurologist and consistent with neuroimaging
  • Time since stroke will include subjects 6-months or more post-stroke
  • Cognitive skills to actively participate (score of 0-1 on items 1b and 1c of the NIH Stroke Scale (NIHSS)
  • Unilateral upper extremity weakness (score of 1-3 on item 5 (arm item) on the NIHSS)

Exclusion Criteria:

  • Subject unavailable for 2-month follow-up
  • Inability to follow-2-step commands
  • Psychiatric diagnoses
  • Current participation in other stroke treatment (i.e.- Botox)
  • Other neurological diagnoses
  • If participant lives further than one hour away and is unwilling to travel for assessment and treatment sessions.
  • Pregnancy
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01146379
10-0230
Yes
Not Provided
Plan to Share IPD: No
Catherine E. Lang, Washington University School of Medicine
Washington University School of Medicine
Not Provided
Principal Investigator: Catherine E Lang, PT, PhD Washington University School of Medicine
Washington University School of Medicine
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP