Strategies for Recovery of Dexterity Post Stroke

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by New York University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01977027
First received: August 23, 2013
Last updated: May 7, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Stroke With Hemiparesis
Other: Alternate Hand Training or Affected Hand Training
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Strategies for Recovery of Dexterity Post Stroke

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • For Phase 1: Adaptation of fingertip forces and movements during grasping. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.

  • For Phase 2: Change in Hand function [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.


Secondary Outcome Measures:
  • Phase 2 - Maintenance of hand function [ Time Frame: 6 weeks after end of training ] [ Designated as safety issue: No ]
    Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments 6-weeks after the end of training.


Estimated Enrollment: 180
Study Start Date: August 2013
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stroke & age-matched Controls

Alternate Hand Training or Affected Hand Training:

40 patients with stroke and 40 control subjects will participate over 7 visits. After completion of informed consent, subjects will undergo clinical assessments (Visit 1) which will involve testing for kinesthetic, visual, tactile and motor impairments and upper limb function. Visit 2, subjects will undergo no contrast MRI to identify lesion location. Healthy controls will not be imaged.

Visits 3-7 will involve psychophysical experiments to test adaptation with short-term Alternate Hand Training and Affected Hand Training. During 5 visits the subjects will grasp and lift an instrumented grip device of different weights, textures and shapes while data is being collected via surface electrodes from, upper arm and back muscles.

Other: Alternate Hand Training or Affected Hand Training
Participants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone.
Phase 2 - Stroke ONLY

Alternate Hand Training or Affected Hand Training:

Subjects will be randomized into two groups one receiving Alternate Hand Training and the other receiving Affected Hand Training. The groups will be matched by age, gender, handedness, side of lesion, extent of motor impairment and lesion location. They will complete 17 Study visits.

Visits 1 and 2 will involve clinical assessments and MRI. Visit 3. Pre-intervention assessments involving grasping and lifting objects of different weights, textures and shapes while fingertip forces, finger and arm movements. Muscle activity and performance is measured.

Visits 4-15. Subjects will participate in 12 training visits for 1 hour a day, twice a week for 6 weeks.

Visits 16-17. Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments (in 2 visits) immediately after 6-weeks of training, and another 6 weeks later.

Other: Alternate Hand Training or Affected Hand Training
Participants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone.

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977027

Contacts
Contact: Preeti Raghavan, MD 212-263-0344 preeti.raghavan@nyumc.org
Contact: Zena Moore, MS 212-263-0344 zena.moore@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Preeti Raghavan, MD    212-263-0344    preeti.raghavan@nyumc.org   
Contact: Zena Moore, BA    212-263-0344    zena.moore@nyumc.org   
Principal Investigator: Preeti Raghavan, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Preeti Raghavan, MD New York University School of Medicine
  More Information

No publications provided

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01977027     History of Changes
Other Study ID Numbers: S12-03117, 1R01HD071978-01A1102617
Study First Received: August 23, 2013
Last Updated: May 7, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by New York University School of Medicine:
Rehabilitation
Fingers
Grasp
Strength
Hand Function
Motor Function
Post Stroke
Brain Infraction
Biomechanis
Neuronal Plasticity
Weight-Bearing

Additional relevant MeSH terms:
Paresis
Stroke
Cerebral Infarction
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 21, 2014