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

Simultaneous Bimanual Training to Improve Motor Function Post-Stroke

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiparesis
• Intervention / Treatment: Other: Simultaneous Bimanual training; Other: Conventional Occupational Therapy

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).

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York Univeristy School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Simultaneous Bimanual training: Patients who have had either an acute/subacute and a Chronic stroke will get training on the devices.	Other: Simultaneous Bimanual training; 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.; Other Names: Control group; Device group
Active Comparator: Control Group; Conventional Occupational Therapy: Patients who have had either an acute/subacute and Chronic Stroke with hemiperisis will get conventional therapy.	Other: Conventional Occupational Therapy; Conventional Occupational Therapy will be given to patients in the control group.; Other Names: Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 84

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: John R Rizzo, MD, New York Univeristy School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: August 19, 2011
• First Submitted That Met QC Criteria: August 22, 2011
• First Posted (Estimate): August 23, 2011

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 18, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Rehabilitation; Hand; Motor Control; Strength; Hand Function; Fingers; Grasp; Motor Function; Post Stroke; Brain Infraction; Neural mechanisms
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Paresis
• Other Study ID Numbers: 11-00118; R#: 11-00118 (Other Identifier: Institutional Review Board - NYU School of Medicine)