Back to resultsStrategies for Recovery of Dexterity Post Stroke
Primary Purpose
Stroke With Hemiparesis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Alternate Hand Training or Affected Hand Training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke With Hemiparesis focused on measuring Rehabilitation, Fingers, Grasp, Strength, Hand Function, Motor Function, Post Stroke, Brain Infraction, Biomechanis, Neuronal Plasticity, Weight-Bearing
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Stroke & age-matched Controls
Phase 2 - Stroke ONLY
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
For Phase 1: Adaptation of fingertip forces and movements during grasping.
5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.
For Phase 2: Change in Hand function
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
Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments 6-weeks after the end of training.
Full Information
NCT ID
NCT01977027
First Posted
August 23, 2013
Last Updated
August 20, 2020
Sponsor
NYU Langone Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01977027
Brief Title
Strategies for Recovery of Dexterity Post Stroke
Official Title
Strategies for Recovery of Dexterity Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
PI left insitution
Study Start Date
August 2013 (undefined)
Primary Completion Date
May 10, 2019 (Actual)
Study Completion Date
May 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke With Hemiparesis
Keywords
Rehabilitation, Fingers, Grasp, Strength, Hand Function, Motor Function, Post Stroke, Brain Infraction, Biomechanis, Neuronal Plasticity, Weight-Bearing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stroke & age-matched Controls
Arm Type
Other
Arm Description
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.
Arm Title
Phase 2 - Stroke ONLY
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Alternate Hand Training or Affected Hand Training
Intervention Description
Participants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone.
Primary Outcome Measure Information:
Title
For Phase 1: Adaptation of fingertip forces and movements during grasping.
Description
5 experiments will be performed over 7 visits to examine the best approach to retrain adaptation.
Time Frame
6 weeks
Title
For Phase 2: Change in Hand function
Description
Subjects will be randomized to Alternate Hand Training or Affected Hand Training arms and receive training twice a week for 6 weeks.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Phase 2 - Maintenance of hand function
Description
Recovery of hand function will be measured by repeating the pre-intervention clinical and grasping assessments 6-weeks after the end of training.
Time Frame
6 weeks after end of training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Rizzo, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
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Strategies for Recovery of Dexterity Post Stroke
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