Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?

This study is currently recruiting participants.

Verified by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), March 2007

First Received: March 27, 2007 Last Updated: March 19, 2008 History of Changes

Sponsor:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator:	Burke Medical Research Institute
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00453843

Purpose

We will test on persons with chronic impairment due to stroke:

whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).
whether we should train the shoulder, elbow, and wrist at the same time or on different days.

Condition	Intervention	Phase
Stroke	Device: rehabilitation robotics Procedure: Movement therapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Proximal and Distal Training on Stroke Recovery

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation

U.S. FDA Resources

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:

Fugl-Meyer
Motor Power

Secondary Outcome Measures:

Wolf Motor Function
SIS

Estimated Enrollment:	160
Study Start Date:	June 2004
Estimated Study Completion Date:	August 2009

Detailed Description:

The Effect of Proximal and Distal Training on Stroke Recovery:

Specific Aim 1. Test whether task specific wrist robotic training improves motor performance among persons with chronic impairment after stroke.

Specific Aim 2. Test whether the order in which robot therapy is delivered influences outcomes (shoulder-and-elbow before wrist vs. wrist before shoulder-and-elbow).

Specific Aim 3. Test whether there is generalization across different joints (shoulder & elbow vs wrist).

Specific Aim 4: Test whether there is any interference between training across different joints among persons with chronic impairment after stroke.

Briefly we will invite persons with chronic impairment due to stroke to participate in a study that will train them first on wrist for 6 weeks and then on the shoulder-and-elbow for an additional 6 weeks or vice-versa. A third group will train in alternate days for 12 weeks on the shoulder-and-elbow or the wrist, while a fourth group will be trained on the shoulder, elbow, and wrist on the same day. Outcomes will be measured using standard instruments as well as robot-based measures. We expect that results from this study will provide an objective basis for maximizing this kind of therapy.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients will be included in the study if they meet the following criteria:

naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
average Motor Power score >= 1/5 or <= 3/5 (neither hemiplegic nor fully recovered motor function in 6 muscles of the shoulder, elbow, and wrist);
informed written consent to participate in the study.

Exclusion Criteria:

Patients will be excluded from the study if they have a fixed contraction deformity in the affected limb.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453843

Contacts

Contact: Avrielle Rykman, O Therapist	(914)597-2220	arykman@burke.org
Contact: Bruce T Volpe, MD	(914)597-2835	BVOLPE@burke.org

Locations

United States, New York
Burke Medical Research Institute	Recruiting
White Plains, New York, United States, 10605
Contact: Avrielle Rykman, O Therapist 914-597-2220 arykman@burke.org
Contact: Bruce T Volpe, MD (914)597-2835 BVOLPE@burke.org
Principal Investigator: Bruce T Volpe, MD

Sponsors and Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Burke Medical Research Institute

Investigators

Principal Investigator:

Hermano I Krebs, PhD

MIT

More Information

Additional Information:

click here for directions This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	R01HD045343
Study First Received:	March 27, 2007
Last Updated:	March 19, 2008
ClinicalTrials.gov Identifier:	NCT00453843 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Stroke
movement therapy
robotics
rehabilitation robotics
shoulder, elbow, wrist

Additional relevant MeSH terms:

Cerebral Infarction
Nervous System Diseases
Stroke
Vascular Diseases
Brain Ischemia

Central Nervous System Diseases
Cardiovascular Diseases
Brain Infarction
Brain Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on November 25, 2009