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

Stroke Clinical Trial

Official title:

The Effect of Proximal and Distal Training on Stroke Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453843
• Other study ID #: R01HD045343
• Status: Completed
• Phase: Phase 2
• First received: March 27, 2007
• Last updated: October 28, 2012
• Start date: June 2004
• Est. completion date: December 2010

Study information

• Verified date: March 2007
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• rehabilitation robotics
sequence of intervention

Procedure:
• Movement therapy
sequence of intervention

Locations

Country	Name	City	State
United States	Burke Medical Research Institute	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Burke Medical Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fugl-Meyer		3 times at baseline, midpoint, completion intervention, and at follow-up	No
Primary	Motor Power		3 times at baseline, midpoint, completion intervention, and at follow-up	No
Secondary	Wolf Motor Function		3 times at baseline, midpoint, completion intervention, and at follow-up	No
Secondary	SIS		3 times at baseline, midpoint, completion intervention, and at follow-up	No

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