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Clinical Trials/NCT01977027
NCT01977027
Terminated
N/A

Strategies for Recovery of Dexterity Post Stroke

NYU Langone Health1 site in 1 country91 target enrollmentAugust 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke With Hemiparesis
Sponsor
NYU Langone Health
Enrollment
91
Locations
1
Primary Endpoint
For Phase 2: Change in Hand function
Status
Terminated
Last Updated
5 years ago

Overview

Brief Summary

Motor learning can be affected by the sensory difficulties that may be experienced as a result of a stroke. This study will help us better understand what kinds of sensory information can help with the re-learning of grasping with the affected hand despite the sensory difficulties produced by the stroke.

Detailed Description

The purpose of this study is to develop, refine and test the 'alternate hand training strategy' to facilitate adaptation, repetition and relearning to restore hand function after stroke. The three aims are: to restore adaptation (Aim 1), facilitate grasp efficiency and normal directional biases during repetition (Aim 2), and enhance the rate of learning to improve hand function and quality of life post stroke (Aim 3). Hypotheses: We hypothesize that alternate hand training will increase the rate of learning and lead to greater improvement in hand function. The results will inform dosing of therapy for optimal relearning.

Registry
clinicaltrials.gov
Start Date
August 2013
End Date
May 10, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Ability to read/write in English
  • Age \> 18 yrs
  • Radiologically verified stroke \> 4 months old (3T structural MRI)
  • Moderate arm motor impairment (Fugl-Meyer Scale \< 60/66)
  • Ability to reach, grasp and lift the test objects with the affected side as assessed by the PI
  • Willingness to complete all clinical assessments and MRI, and comply with training protocols
  • Ability to give informed consent and HIPPA certificationsPlease list all exclusion criteria for study:

Exclusion Criteria

  • Sensorimotor impairments in the unaffected hand
  • Severe visual or sensory impairment, including neglect on the affected side
  • Significant cognitive dysfunction (score \< 24 on Folstein's Mini Mental Status Examination)
  • Severe or unstable spasticity on treatment with Botulinum toxin or intrathecal baclofen
  • Depression (Geriatric Depression Scale score \<11)
  • Major disability (modified Rankin Scale \> 4)
  • Previous neurological illness, complicated medical condition, or significant injury to either upper extremity

Outcomes

Primary Outcomes

For Phase 2: Change in Hand function

Time Frame: 6 weeks

Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.

For Phase 1: Adaptation of fingertip forces and movements during grasping.

Time Frame: 6 weeks

5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.

Secondary Outcomes

  • Phase 2 - Maintenance of hand function(6 weeks after end of training)

Study Sites (1)

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