Skip to main content
OpenTrials
Completed

NCT Number: NCT00453843

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Burke Medical Research Institute

White Plains, New York, 10605, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rehabilitation robotics

Device

sequence of intervention

Other names: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)

Movement therapy

Procedure

sequence of intervention

Other names: InMotion2.0 (InMotion Arm) and InMotion3.0 (InMotion Wrist)

Primary outcomes

  1. Fugl-Meyer

    Time frame: 3 times at baseline, midpoint, completion intervention, and at follow-up

  2. Motor Power

    Time frame: 3 times at baseline, midpoint, completion intervention, and at follow-up

Secondary outcomes

  1. Wolf Motor Function

    Time frame: 3 times at baseline, midpoint, completion intervention, and at follow-up

  2. SIS

    Time frame: 3 times at baseline, midpoint, completion intervention, and at follow-up

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

  • Burke Medical Research Institute

Registry information

Official study title

The Effect of Proximal and Distal Training on Stroke Recovery

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Mar 29, 2007
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.