Does More Practice Improve Arm Movement After Stroke?

NCT01146379 | Completed Phase 2 Results DMC

• 1 other identifier: 10-0230
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; upper extremity; paresis; function; translational research

Outcome Measures

Primary Outcomes (1)

• 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.

  9 weeks

Study Arms (4)

Low Movement Dose, 3200 total reps

EXPERIMENTAL

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.

Other: Intensive task-specific upper extremity rehabilitation

Medium Movement Dose, 6400 total reps

EXPERIMENTAL

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.

Other: Intensive task-specific upper extremity rehabilitation

High Movement Dose, 9600 total reps

EXPERIMENTAL

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.

Other: Intensive task-specific upper extremity rehabilitation

Individual Maximum High Movement Dose

EXPERIMENTAL

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.

Other: Intensive task-specific upper extremity rehabilitation

Interventions

Intensive task-specific upper extremity rehabilitation OTHER

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.

High Movement Dose, 9600 total reps; Individual Maximum High Movement Dose; Low Movement Dose, 3200 total reps; Medium Movement Dose, 6400 total reps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (9)

• 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.

  PMID: 24458962 BACKGROUND

• 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.

  PMID: 24553104 BACKGROUND

• 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.

  PMID: 25068258 BACKGROUND

• 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.

  PMID: 25497517 BACKGROUND

• 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.

  PMID: 25742378 BACKGROUND

• 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.

  PMID: 25776118 BACKGROUND

• 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.

  PMID: 25896988 BACKGROUND

• 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.

  PMID: 26146964 BACKGROUND

• 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.

  PMID: 26402404 BACKGROUND

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Catherine Lang
• Organization: Washington University School of Medicine

langc@wustl.edu

314-286-1945

Study Officials

• Catherine E Lang, PT, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy, Neurology, and Occupational Therapy

Study Record Dates

• First Submitted: June 3, 2010
• First Posted: June 17, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 24, 2017
• Results First Posted: February 24, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)