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Does More Practice Improve Arm Movement After Stroke?

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intensive task-specific upper extremity rehabilitation
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, upper extremity, paresis, function, translational research

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Low Movement Dose, 3200 total reps

Medium Movement Dose, 6400 total reps

High Movement Dose, 9600 total reps

Individual Maximum High Movement Dose

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in Action Research Arm Test (ARAT) Score Per Week
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.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2010
Last Updated
January 3, 2017
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01146379
Brief Title
Does More Practice Improve Arm Movement After Stroke?
Official Title
Dose Response of Movement Practice During Stroke Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, upper extremity, paresis, function, translational research

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low Movement Dose, 3200 total reps
Arm Type
Experimental
Arm Description
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.
Arm Title
Medium Movement Dose, 6400 total reps
Arm Type
Experimental
Arm Description
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.
Arm Title
High Movement Dose, 9600 total reps
Arm Type
Experimental
Arm Description
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.
Arm Title
Individual Maximum High Movement Dose
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Intensive task-specific upper extremity rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Action Research Arm Test (ARAT) Score Per Week
Description
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.
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine E Lang, PT, PhD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24458962
Citation
Bailey RR, Lang CE. Upper-limb activity in adults: referent values using accelerometry. J Rehabil Res Dev. 2013;50(9):1213-22. doi: 10.1682/JRRD.2012.12.0222.
Results Reference
background
PubMed Identifier
24553104
Citation
Urbin MA, Hong X, Lang CE, Carter AR. Resting-state functional connectivity and its association with multiple domains of upper-extremity function in chronic stroke. Neurorehabil Neural Repair. 2014 Oct;28(8):761-9. doi: 10.1177/1545968314522349. Epub 2014 Feb 18.
Results Reference
background
PubMed Identifier
25068258
Citation
Bailey RR, Klaesner JW, Lang CE. An accelerometry-based methodology for assessment of real-world bilateral upper extremity activity. PLoS One. 2014 Jul 28;9(7):e103135. doi: 10.1371/journal.pone.0103135. eCollection 2014.
Results Reference
background
PubMed Identifier
25497517
Citation
Urbin MA, Waddell KJ, Lang CE. Acceleration metrics are responsive to change in upper extremity function of stroke survivors. Arch Phys Med Rehabil. 2015 May;96(5):854-61. doi: 10.1016/j.apmr.2014.11.018. Epub 2014 Dec 9. Erratum In: Arch Phys Med Rehabil. 2016 Jan;97(1):178.
Results Reference
background
PubMed Identifier
25742378
Citation
Urbin MA, Bailey RR, Lang CE. Validity of body-worn sensor acceleration metrics to index upper extremity function in hemiparetic stroke. J Neurol Phys Ther. 2015 Apr;39(2):111-8. doi: 10.1097/NPT.0000000000000085.
Results Reference
background
PubMed Identifier
25776118
Citation
Bailey RR, Birkenmeier RL, Lang CE. Real-world affected upper limb activity in chronic stroke: an examination of potential modifying factors. Top Stroke Rehabil. 2015 Feb;22(1):26-33. doi: 10.1179/1074935714Z.0000000040. Epub 2015 Jan 21.
Results Reference
background
PubMed Identifier
25896988
Citation
Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.
Results Reference
background
PubMed Identifier
26146964
Citation
Waddell KJ, Birkenmeier RL, Bland MD, Lang CE. An exploratory analysis of the self-reported goals of individuals with chronic upper-extremity paresis following stroke. Disabil Rehabil. 2016;38(9):853-7. doi: 10.3109/09638288.2015.1062926. Epub 2015 Jul 6.
Results Reference
background
PubMed Identifier
26402404
Citation
Lang CE, Lohse KR, Birkenmeier RL. Dose and timing in neurorehabilitation: prescribing motor therapy after stroke. Curr Opin Neurol. 2015 Dec;28(6):549-55. doi: 10.1097/WCO.0000000000000256.
Results Reference
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Does More Practice Improve Arm Movement After Stroke?

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