Strategies for Recovery of Dexterity Post Stroke

NCT ID: NCT01977027

Last Updated: 2020-08-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2019-05-10

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.

Conditions

Stroke With Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Alternate Hand Training or Affected Hand Training

Intervention Type: OTHER

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.

Group Type: OTHER

Alternate Hand Training or Affected Hand Training

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John R Rizzo, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

1R01HD071978-01A1102617

Identifier Type: OTHER

Identifier Source: secondary_id

1R01HD071978-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-03117

Identifier Type: -

Identifier Source: org_study_id