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Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke

Primary Purpose

Stroke, Hemiparesis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simultaneous Bimanual training
Conventional Occupational Therapy
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Stroke focused on measuring Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Hand Function, Post Stroke, Neural mechanisms, Motor Control, Motor Function

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking.
  • Subjects must have had a unilateral stroke

Exclusion Criteria:

  • Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion.
  • Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
  • Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
  • History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
  • Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
  • Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol

Sites / Locations

  • New York Univeristy School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control Group

Arm Description

Simultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.

Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.

Outcomes

Primary Outcome Measures

Measurement of hand function
The outcome measures using the devices will include: hand function range of motion stiffness extent of impairment on the affected side temperature differences between the two sides of the body, and skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.

Secondary Outcome Measures

Measurement of Hand Function
The outcome measures using the devices will include: hand function range of motion stiffness extent of impairment on the affected side temperature differences between the two sides of the body, and skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.

Full Information

First Posted
August 19, 2011
Last Updated
August 18, 2020
Sponsor
NYU Langone Health
Collaborators
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT01422005
Brief Title
Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke
Official Title
Simultaneous Bimanual Training to Improve Motor Function Post-Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (Actual)
Primary Completion Date
December 12, 2019 (Actual)
Study Completion Date
December 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Icahn School of Medicine at Mount Sinai

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to examine if practicing joint movements using specially designed devices can help in the recovery of muscle function in the arm/hand after a stroke. Subjects may qualify for participation in this study because they had a stroke and have had difficulty using their affected arm/hand ever since.
Detailed Description
Stroke is a leading cause of long-term adult disability in the United States, and hemiparesis is the most common motor impairment that frequently leads to persistent deficits in hand function. The mechanisms of recovery of hand motor function after stroke are poorly understood, and the protocols used in clinical practice lack a solid scientific rationale. The long-term objective of this research is to understand the neural mechanisms underlying the recovery of voluntary motor functions in brain-injured patients in order to provide a more objective and scientific basis to rehabilitation protocols used in clinical practice. These devices will be used to facilitate the training of either unimanual or bimanual movements that can be used both in the acute and chronic post-stroke period, even when there is little active movement in the affected upper extremity. The specially designed mechanical devices (BAT, PST and WIFIT), Psychophysical methods using an instrumented glove, and electromyographic recordings from upper extremity muscles to investigate the following specific aims in patients with post-stroke hemiparesis will lead to: greater extensor muscle activation and out of synergy movement compared with unimanual training facilitated by an external agent (e.g. another person). Bimanual training with the specially designed mechanical devices (BAT, PST and WIFIT) over 6 weeks will produce greater functional recovery in the affected upper extremity in patients with post-stroke hemiparesis, compared with conventional therapy. The gains in motor control and function will be greater in patients who begin bimanual training in the acute post-stroke phase (0-6) months, compared with those that begin in the chronic post-stroke phase (> 6 months).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis
Keywords
Rehabilitation, Fingers, Grasp, Hand, Strength, Brain Infraction, Hand Function, Post Stroke, Neural mechanisms, Motor Control, Motor Function

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Simultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.
Intervention Type
Other
Intervention Name(s)
Simultaneous Bimanual training
Other Intervention Name(s)
Device group, Control group
Intervention Description
Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices. Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy.
Intervention Type
Other
Intervention Name(s)
Conventional Occupational Therapy
Other Intervention Name(s)
Control Group
Intervention Description
Conventional Occupational Therapy will be given to patients in the control group.
Primary Outcome Measure Information:
Title
Measurement of hand function
Description
The outcome measures using the devices will include: hand function range of motion stiffness extent of impairment on the affected side temperature differences between the two sides of the body, and skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Measurement of Hand Function
Description
The outcome measures using the devices will include: hand function range of motion stiffness extent of impairment on the affected side temperature differences between the two sides of the body, and skin sensitivity to pressure. Testing of independent finger movements and grasp-release during a functional task will be measured using an instrumented glove with concurrent electromyographic and 3-D Motion analysis of joint movements and muscle activity patterns.
Time Frame
Day 84

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to follow study instructions and likely to complete all required visits; ability to comply with the therapy protocol as assessed by the investigator; must be English speaking. Subjects must have had a unilateral stroke Exclusion Criteria: Severe upper extremity spasticity suggested by an Ashworth score of >3 at any joint, or restriction of full passive range of motion. Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression. Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study. History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance. Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease. Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John R Rizzo, MD
Organizational Affiliation
New York Univeristy School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York Univeristy 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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Study of the Recovery of Muscle Function in the Arm/Hand After a Stroke

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