ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?

This study is currently recruiting participants.
Verified by National Institute of Child Health and Human Development (NICHD), March 2007

Sponsors and Collaborators: National Institute of Child Health and Human Development (NICHD)
Burke Medical Research Institute
Information provided by: 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:

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

MedlinePlus related topics:   Rehabilitation   

U.S. FDA Resources

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

Further study details as provided by 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:

  1. naïve subjects who have never experienced robot-assisted therapy as inpatients or outpatients;
  2. first single focal unilateral lesion with diagnosis verified by brain imaging (MRI or CT scans) that has occurred at least 6 months prior;
  3. cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects);
  4. 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);
  5. 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

Investigators
Principal Investigator:     Hermano I Krebs, PhD     MIT    
  More Information

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

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

Keywords provided by National Institute of Child Health and Human Development (NICHD):
Stroke  
movement therapy  
robotics  
rehabilitation robotics  
shoulder, elbow, wrist  

Study placed in the following topic categories:
Cerebral Infarction
Stroke
Vascular Diseases
Brain Ischemia
Central Nervous System Diseases
Ischemia
Brain Infarction
Brain Diseases
Infarction
Cerebrovascular Disorders

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 29, 2008




Links to all studies - primarily for crawlers