Clinical trial NCT01977027: Strategies for Recovery of Dexterity Post Stroke
Official title: Strategies for Recovery of Dexterity Post Stroke
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke With Hemiparesis
Keywords: Rehabilitation
Fingers
Grasp
Strength
Hand Function
Motor Function
Post Stroke
Brain Infraction
Biomechanis
Neuronal Plasticity
Weight-Bearing
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2013-11-06
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: For Phase 1: Adaptation of fingertip forces and movements during grasping.
timeFrame: 6 weeks
measure: For Phase 2: Change in Hand function
timeFrame: 6 weeks
Secondary outcomes:
measure: Phase 2 - Maintenance of hand function
timeFrame: 6 weeks after end of training
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: John R Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
References: