Strategies for Recovery of Dexterity Post Stroke

NCT01977027 | Terminated DMC

• 3 other identifiers: 12-031171R01HD071978-01A11026171R01HD071978-01
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke With Hemiparesis

Keywords

Rehabilitation; Fingers; Grasp; Strength; Hand Function; Motor Function; Post Stroke; Brain Infraction; Biomechanis; Neuronal Plasticity; Weight-Bearing

Outcome Measures

Primary Outcomes (2)

• 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.

  6 weeks

• 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.

  6 weeks

Secondary Outcomes (1)

• Phase 2 - Maintenance of hand function

  6 weeks after end of training

Study Arms (2)

Stroke & age-matched Controls

OTHER

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

Phase 2 - Stroke ONLY

OTHER

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

Interventions

Alternate Hand Training or Affected Hand Training OTHER

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

Phase 2 - Stroke ONLY; Stroke & age-matched Controls

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

Study Officials

• John R Rizzo, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: November 6, 2013
• Study Start: August 1, 2013
• Primary Completion: May 10, 2019
• Study Completion: May 10, 2019
• Last Updated: August 24, 2020

Record last verified: 2020-08

Locations

US (1)