Full Text View
Tabular View
No Study Results Posted
Related Studies
Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
This study is currently recruiting participants.
Study NCT00453843   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: March 27, 2007   Last Updated: March 19, 2008   History of Changes

March 27, 2007
March 19, 2008
June 2004
 
  • Fugl-Meyer
  • Motor Power
Same as current
Complete list of historical versions of study NCT00453843 on ClinicalTrials.gov Archive Site
  • Wolf Motor Function
  • SIS
Same as current
 
Shoulder, or Elbow, or Wrist: What Should we Train First After a Stroke?
The Effect of Proximal and Distal Training on Stroke Recovery

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Stroke
  • Device: rehabilitation robotics
  • Procedure: Movement therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
160
August 2009
 

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.

Both
21 Years and older
No
Contact: Avrielle Rykman, O Therapist (914)597-2220 arykman@burke.org
Contact: Bruce T Volpe, MD (914)597-2835 BVOLPE@burke.org
United States
 
NCT00453843
 
R01HD045343
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Burke Medical Research Institute
Principal Investigator: Hermano I Krebs, PhD MIT
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
March 2007

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