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

This study has been completed.
Sponsor:
Collaborator:
Burke Medical Research Institute
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00453843
First received: March 27, 2007
Last updated: October 28, 2012
Last verified: March 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Proximal and Distal Training on Stroke Recovery

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Fugl-Meyer [ Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up ] [ Designated as safety issue: No ]
  • Motor Power [ Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wolf Motor Function [ Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up ] [ Designated as safety issue: No ]
  • SIS [ Time Frame: 3 times at baseline, midpoint, completion intervention, and at follow-up ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: June 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: proximal to distal training Device: rehabilitation robotics
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Procedure: Movement therapy
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Experimental: distal to proximal Device: rehabilitation robotics
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Procedure: Movement therapy
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Experimental: proximal and distal on alternate days Device: rehabilitation robotics
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Procedure: Movement therapy
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Experimental: proximal and distal same day Device: rehabilitation robotics
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)
Procedure: Movement therapy
sequence of intervention
Other Name: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)

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

Locations
United States, New York
Burke Medical Research Institute
White Plains, New York, United States, 10605
Sponsors and Collaborators
Burke Medical Research Institute
Investigators
Principal Investigator: Hermano I Krebs, PhD MIT
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00453843     History of Changes
Other Study ID Numbers: R01HD045343
Study First Received: March 27, 2007
Last Updated: October 28, 2012
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:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 22, 2014