Strategies for Recovery of Dexterity Post Stroke

Stroke With Hemiparesis Clinical Trial

Official title:

Strategies for Recovery of Dexterity Post Stroke

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01977027
• Other study ID #: 12-03117
• Secondary ID: 1R01HD071978-01A
• Status: Terminated
• Phase: N/A
• Start date: August 2013
• Est. completion date: May 10, 2019

Study information

• Verified date: August 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 91
• Est. completion date: May 10, 2019
• Est. primary completion date: May 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Paresis
• Stroke
• Stroke With Hemiparesis

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	6 weeks after end of training